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Online Event, OH United States

July 2017

Webinar: The Value of Preclinical Studies from Concept to Commercialization

July 13, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA on July 13 for this upcoming webinar. It is a common misconception within the medical device industry that preclinical studies only occur during the design phase of the Product Development Process (PDP). In reality, they have value at every stage of the development lifecycle – from concept efforts through product launch, and post-market support. Join us for our upcoming webinar as we discuss the critical role preclinical studies play throughout the PDP process. Presenter Mike Bravo (Director, Preclinical…

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Webinar: Understanding the FDA/CMS Parallel Review Process

July 18, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

NAMSA is excited to present a special joint webinar with the Medical Alley Association (MAA). Learn direct from medical device industry experts, Ken Skodacek (Policy Analyst), FDA Center for Devices and Radiological Health; and Seth Goldenberg (Director of Product Development Strategy), NAMSA, as they discuss the FDA/CMS Parallel Review Process. There are numerous stakeholders that must be considered when bringing a medical device to market. These include regulatory agencies, healthcare payers, healthcare providers, patients, and healthcare technology assessment organizations, just…

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Webinar: Understanding Medical Device Regulatory Pathways in China and Japan

July 20, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

The Countries of China and Japan each present their own unique set of challenges pertaining to medical device development. This is especially true for foreign manufacturers as they strive to stay abreast of the quickly changing device regulations and product approval processes in these sometimes tough-to-navigate geographies. Join NAMSA for a webinar with XTalks on July 20, 2017, as NAMSA regulatory experts Lei Yang, Medical Research Manager (China); and Kei Yoshikawa, Medical Research Manager (Japan), present information that will assist…

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Webinar: Cybersecurity for Medical Devices

July 25, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Register for July's R&Q Intelligence Series webinar. The free session will be held on Tuesday, July 25 from 1:00pm - 2:00pm EST, and the presentation slides and webinar recording will be made available to all registrants. The emphasis on security is here. And here to stay. The regulations at the federal level mandate that healthcare organizations, financial institutions, and federal agencies should protect their systems, the information they collect, and consider the risks to their user population. This webinar will outline…

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Webinar: Monitor, Measure, Evaluate, Evolve

July 26, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

PR needs to re-establish itself. All too often it's undervalued as a tool in a company's arsenal. But you know it's essential, because it builds your brand, generates trust, and ultimately drives revenue. So how can you prove it? Serena Ehrlich, director of social and evolving media for Business Wire, is going to share with us exactly how to MONITOR, MEASURE, EVALUATE, and EVOLVE, so you can fearlessly execute your communications strategy. Webinar is sponsored by Agility PR Solutions. On…

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August 2017

MHSRS Webinar presented by G2G, August

August 2, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Background: In this webinar, you will learn about government opportunities for biosciences with a focus on the upcoming MHSRS Conference. The MHSRS (Military Health System Research Symposium Conference) is the largest military medical conference of the year. It is in Kissimmee, FL on August 27-30, 2017. Many DoD, DHA and USAMRMC leadership, program managers, clinicians, researchers, academia and industry attend and are eager to learn about medical innovations and ways to collaborate and bring them to market.Topics to be covered:…

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R&Q Webinar: Risk-Based Approach to ISO 13485:2016

August 22, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS. The concepts of risk management are not new. In previous editions of ISO 13485, risk management primarily focused on product risk using design risk. ISO 13485:2016 places greater…

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NAMSA Webinar: ISO 13485:2016 – Ensuring a Smooth Transition Through Effective Preparation

August 31, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

In 2016, significant revisions were made to the quality management standard ISO 13485, an internationally recognized standard for all medical product manufacturers. The updated changes to ISO 13485 – the first since 2003 – demonstrate the increasing Quality System requirements for the global medical device industry and how organizations must adhere to the forthcoming and revised standard. Join NAMSA’s regulatory expert, Linda Mummah Schendel, Principal Medical Research Manager, as we discuss the steps that medical device manufacturers should take now…

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September 2017

NAMSA Webinar: The Value of Preclinical Studies from Concept to Commercialization – September

September 7, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA for this webinar on September 7. It is a common misconception within the medical device industry that preclinical studies only occur during the design phase of the Product Development Process (PDP). In reality, they have value at every stage of the development lifecycle – from concept efforts through product launch, and post-market support. Join us for our upcoming webinar as we discuss the critical role preclinical studies play throughout the PDP process. Presenter Mike Bravo (Director, Preclinical Strategy-NAMSA) will…

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Barnes Business Coaching Webinar: Better Communication for Better Business Results

September 7, 2017 @ 12:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join Michael Barnes, Barnes Business Coaching, an ActionCOACH Franchise for this webinar on Thursday, September 7 at 12:00pm. Have you ever had an experience where you and another person are talking and they just don't get what you're saying? If so, you know how much of a challenge this can be. Miscommunication can cost you dearly! Prospects: Lose the sale Clients: Get an unhappy client Bosses: Have your boss question your abilities Employees: Not get the work done you need Friends:…

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Charles River Webinar: 3D Tumors To Change Your Preclinical Approach

September 14, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join Charles River for this complimentary webinar on using 3D tumor models to predict better in vivo and translational results. In a constant battle to find more efficient and effective ways to test oncology preclinical candidates, 3D in vitro culture methods for PDX-derived tumor cells have shown promise of in vivo-like growth characteristics, invasion, and responses to therapeutics. With these methods, we can perform high-throughput in vitro PDX screening that identifies active and selective molecules, and select favorable PDX tumor…

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BIO Webinar: Small Business Funding Opportunities from the National Cancer Institute

September 14, 2017 @ 1:00 pm - 2:30 pm
Webinar Online Event, OH United States

Join our national partner BIO for this informational webinar on September 14, 2017. Are you looking for funding to advance your cancer technology? Join Michael Weingarten and Christie Canaria of National Cancer Institute Small Business Innovation Research (NCI SBIR) Development Center for an online information session on Thursday, September 14, 2017! They will be presenting funding opportunities and other resources for startups in cancer technology. You will also learn about new targeted funding opportunities in cancer detection, diagnosis, and treatment in…

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ShareVault Webinar: Corporate Risk Reduction: How to Create a Culture of Compliance

September 14, 2017 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join ShareVault for a cybersecurity webinar on September 14. With cybersecurity vulnerabilities flowing unabated, securing client information continues to be an ongoing challenge. Ensuring your IT staff is trained and ready is no longer sufficient. Organizations need to educate employees at every level in order to attain a culture of compliance from within. Beginning at the top, organizations must gain visibility and control over internal and external risk. This webinar will provide insight into creating an effective governance, risk and compliance…

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Smithers Pira Webinar: Medical Devices – Introduction to Design Verification Physical Testing

September 26, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Design verification testing is used to demonstrate and document that medical devices conform with their design requirements. Smithers Pira experts Chris Berry and Nikki Lucas make this complex topic accessible in a new webinar. In 60 minutes they will provide an overview of design verification testing for the physical and functional characteristics of medical devices. The webinar will explore key considerations when developing a test program. Presenters Chris and Nikki will discuss the development of standard and bespoke test methods…

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R&Q Webinar: EU MDR / CER Portfolio Planning

September 26, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio Leadership Member R&Q for this free webinar on September 26 at 1PM. Know the essential EU MDR Portfolio planning requirements. Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules.…

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Webinar: Orthotopics: A Valuable Investment for Your Preclinical Oncology Studies

September 28, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Imaging is expensive. It always sounds like an amazing addition to a study, especially when you see the pictures and the data that it provides. Considering orthotopics can be more relevant models, you want to say YES, but when you see the price, you almost can’t say NO fast enough. Charles River wants to tell you why it is a key component to preclinical oncology studies.

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ShareVault Webinar: From Founding to Exit: A Life Science Business Founder Perspective

September 28, 2017 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio - BIO Business Solutions® Partner ShareVault for this webinar on September 28 at 2PM.  BIO's preferred VDR partner, ShareVault, presents a FREE opportunity to learn how to move a life science organization from founding to exit. Join us for a web panel discussion on how to successfully move a life science organization from founding to exit. During this discussion, founders will provide guidance on how executive teams can partner business and science together to overcome the stumbling blocks…

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Webinar: 21st Century Cures Act Trusted Exchange Framework and Common Agreement Meeting

September 29, 2017 @ 1:00 pm - 5:00 pm
Webinar Online Event, OH United States

The Office of the National Coordinator for Health Information Technology (ONC) will host the second in a series of meetings and webinars to inform their work in support of the 21st Century Cures Act trusted exchange framework and common agreement provisions outlined in Section 4003 of the law. ONC looks forward to working with stakeholders on implementation of this Cures provision—an integral component of the nationwide network-to-network exchange of health data and a critical part of ONC’s charge to support…

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October 2017

ShareVault Webinar: Practical Application of Artificial Intelligence in Drug Discovery and Development

October 12, 2017 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States + Google Map

Join BioOhio partner ShareVault for a webinar on October 12 at 2 PM. There is a lot of noise around artificial intelligence (AI) and how it is or isn’t changing the drug development landscape. One of the key benefits of AI is finding the signal in the noise, and in this webinar we aim to do the same. In this web panel, we bring together 3 practitioners in the space who are enabling the application of AI in drug discovery…

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Webinar: ISO 13485:2016: How to Incorporate Risk-Based Quality Systems That Lead to Efficient Decision Making

October 19, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

The use of risk management per International Organization for Standardization (ISO) 14971 has been long-established and is typically well understood within the medical device development industry. However, with forthcoming updates to ISO 13485:2016 just on the horizon, there will be an even greater importance placed on utilizing risk-based decision making and planning for quality system elements unrelated to design controls. These changes will require further learning and understanding by medical device manufacturers well in advance of the mandatory compliance date…

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NAMSA Webinar: ISO 13485:2016: How to Incorporate Risk-Based Quality Systems That Lead to Efficient Decision Making

October 19, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on October 19, 2017 at 10AM. The use of risk management per International Organization for Standardization (ISO) 14971 has been long-established and is typically well understood within the medical device development industry. However, with forthcoming updates to ISO 13485:2016 just on the horizon, there will be an even greater importance placed on utilizing risk-based decision making and planning for quality system elements unrelated to design controls. These changes will require further learning and…

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Webinar: Navigating Government, Exerting Influence and Securing Funding for Nonprofits

October 25, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

With decades of experience in public policy, accessing government funding, and advocacy on the Hill and at the Statehouse, G2G Consulting presenters will offer practical insights on how government operates, running effective advocacy campaigns, and securing government funding, including capital funding from the state. Topics include: Federal and State Budget Processes State Capital Budget Requests Key Timelines Grant Tracking and Sources of Government Funding Decision-Makers for Funding and Policy Advocacy Tools & Case Studies Insider Tips on How to Succeed…

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November 2017

Webinar: Preparing Your CER For MDR

November 28, 2017 @ 8:00 am - 5:00 pm
Webinar Online Event, OH United States

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market for a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. The time to plan and act on these changes is now. The Clinical Evaluation Report (CER) is required under the…

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NAMSA Webinar: ISO 10993 Update: Understanding the Use and Value of Biocompatibility Standards for Medical Devices

November 29, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for this webinar on November 29 from 12 pm - 1 pm. Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan. In today’s world, however, the simplicity of the above process is increasingly questioned given the recent requirements of ISO 10993-1: Biological evaluation…

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December 2017

Webinar: U.S. FDA Advisory Panel Meetings, Strategies to Maximize Success, presented by NAMSA

December 7, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

To better understand how to effectively prepare and plan for successful Advisory Panel meetings, NAMSA is partnering with X-Talks to present the webinar, “U.S. FDA Advisory Panel Meetings: Strategies to Maximize Success”

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January 2018

Webinar: Gene & Cell Therapies – It’s Show Time!

January 16, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Until recently, the concept that the genetic status of an individual was fixed and unalterable was widely accepted. However, in the last several years, advances in human genetics, cell biology, and gene therapy have resulted in a fundamental change in this therapeutic paradigm. Today’s physicians are not only using gene and cell therapies to help patients live better with their genetic constitutions, but are also using novel therapies to alter the genetic makeup of the patient. In ShareVault's upcoming webinar,…

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Webinar: QMS for EU MDR

January 23, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

New EU regulations for medical devices come into full application by May 2020. The parallel regulations for IVDs apply from 2022. This particularly affects those organizations that may have not been previously been subject to regulation (e.g., distributors, importers) and those for whom the regulatory requirements have increased (manufacturers, authorized representatives). Medical device organizations must have an adequate quality management system in place to maintain access to the EU market and other markets that recognize EU authorizations. They need to…

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Webinar: NCATS SBIR & STTR Funding Support for Entrepreneurs and Researchers in Biotech

January 30, 2018 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Are you an entrepreneur launching a biotech or healthcare technology business and finding the funding landscape to be complex? The National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) may be able to assist through its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. This webinar is brought to you by NCATS, NC Biosciences Organization and Virginia BIO. Featured Speaker Lili M. Portilla, M.P.A., Director, Strategic Alliances, NCATS, NIH, U.S. Department of Health and Human Services…

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February 2018

Battelle Webinar: Insidious Cardiotoxicity

February 16, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio member Battelle and the SOT Cardiovascular Toxicology Specialty Section for Insidious Cardiotoxicity: Ubiquitous and important, but difficult and expensive to predict! Cardiovascular (CV) functions may be affected adversely by drugs within seconds of exposure or insidiously requiring weeks to decades during or after exposure (e.g., doxorubicin, trastuzumab, sunitinib, digitalis, fenfluramine). Insidious toxicity occurs when a sublethal set of signs results from lengthy exposures to a chemical. It is simple to predict acute deaths to strychnine, but is infinitely more challenging to identify…

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NAMSA Webinar: How to Use Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

February 21, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for this webinar on February 21 from 1-2 PM. Often, real-world data (RWD) routinely collected during patient treatment and management provides tangible information pertaining to the experiences of medical device end-users. These data sources range from medical device registries, electronic health records (EHRs), claims and billing data, patient-generated information, and even data gathered from mobile devices. Under the right conditions, information derived from these sources can be utilized to support various medical device regulatory pathways and…

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R&Q Intelligence Series Webinar: Technical Documentation for EU MDR

February 27, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

This webinar will provide the background and requirements that medical device manufacturers will need for their technical documentation to meet the requirements of the European Medical Device Regulations (EU MDR). This is designed to set the foundation for your planning of next steps to keep your product on the market in Europe. It's time to know the essential EU MDR requirements. It's also time to plan and act. The upcoming EU MDR changes are significant, potentially impacting your device classification…

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Webinar: Getting Treatment Options to Rare Disease Patients Faster: Putting Patients First in Clinical Trials

February 28, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

The theme for Rare Disease Day, February 28, 2018 is “research.” In clinical research, the relationship between patient and researcher is symbiotic – the patient community needs researchers for cures and treatments and researchers need patients to participate to ensure meaningful outcomes. With rare disease, this relationship is intensified on both sides: patients and their caregivers often have few treatment options while researchers have a smaller pool of potential participants. Join us on Rare Disease Day as experts from Medpace,…

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Webinar: Benefit Trends and Strategies for Life Sciences Organizations

February 28, 2018 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio member Aon for the webinar Benefits Trends and Strategies for Life Sciences Organizations on February 28 at 2PM. For life sciences organizations, devising an effective and engaging employee benefits strategy can be especially difficult in today’s environment. Mobile and diverse workforces, multiple locations, multi-generational employees, manufacturing concerns, and union-related issues are just some of the additional variables adding to the complexity of this challenge. Join Aon experts as they discuss how life sciences organizations can take on these…

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March 2018

Webinar: Leveraging the Evolving Regulatory Landscape to Accelerate Drug & Medical Devices Development

March 1, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Please join BioOhio partner YourEncore on March 1 for the webinar Leveraging the Evolving Regulatory Landscape to Accelerate Drug & Medical Devices Development. The FDA is consistently introducing and evolving policies to drive innovation, reduce risk, and improve patient safety. Your company’s ability to understand and respond to these shifts can make your company stand out or fall behind the competition. Join YourEncore’s Minnie Baylor-Henry and Dr. Tim Franson as they discuss these evolving regulatory shifts (e.g. 21st Century Cures, PDUFA…

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G2G Webinar: Military Medical Funding – How it Works & What You Need to do Now to Prepare for MHSRS 2018

March 6, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Please join BioOhio member G2G for a webinar on March 6 from 12-1pm. Once you RSVP with gkapcar@G2Gconsulting.com, you will receive the link to participate in the webinar. This webinar will give you an up-to-the-minute analysis of what is happening with the federal budget process and timing for the coming year, best opportunities for biosciences, and preparation for successful participation in the largest military medical R&D conference hosted by the Military Health System Research Symposium (MHSRS). Submitting an abstract and being selected…

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Webinar – Combination Product Updates

March 20, 2018 @ 3:00 pm - 4:30 pm
Webinar Online Event, OH United States

Join the FDA on March 20 for the webinar Combination Product Updates for “Acceptance and Filing Reviews for Premarket Approval Applications” and “Refuse to Accept Policy for 510(k)s”. On January 30, 2018, the FDA issued updated final guidance documents: Refuse to Accept Policy for 510(k)s Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) These guidance documents explain the procedures and criteria the FDA intends to use in accepting or refusing a 510(k) or PMA submission. It includes checklists to identify…

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R&Q Intelligence Series Webinar: Risk Management Updates

March 27, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q on March 27 for their Intelligence Series Webinar: Risk Management Updates. This webinar will provide the background and requirements that medical device manufacturers will need for creating, updating or otherwise remediating the risk management files to meet the requirements of the European Medical Device Regulations (EU MDR), In vitro Diagnostic Regulation (IVDR) and other worldwide requirements. This presentation is designed to set the foundation for your medical device risk management files in alignment with Clinical Evaluation Reports…

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NAMSA Webinar: Leveraging Post-Market Data to Support EU MDR Compliance

March 28, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for Leveraging Post-Market Data to Support EU MDR Compliance on March 28 at 10AM. Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities have historically been a critical part of conformity with the Medical Device Directive 93/42 EEC (MDD) and Active Implantable Device Directive 90/385/EEC (AIMD). However, over the last year, there has been an increased emphasis on PMS and PMCF compliance initiatives under the new EU Medical Device Regulation 2017/745 (MDR). The amplified focus on…

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Ohio Manufacturers’ Association Webinar: Setting Your Industry Sector Partnership Strategy, A Case Study

March 28, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join the Ohio Manufacturers' Association for Setting Your Industry Sector Partnership Strategy, A Case Study, a webinar on Wednesday, March 28 from 10:00 - 11:00 a.m. Manufacturers across Ohio are embracing Industry Sector Partnerships as a strategy to solve workforce issues. In this webinar, participants will hear from one of Ohio’s established partnerships, ConxusNEO, to learn how local manufacturers are collaborating with area workforce suppliers to solve pressing talent and skill shortages. Please join us to learn how the industry sector…

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BIO Webinar: Not if, but When: Preparing for Cyber Perils

March 29, 2018 @ 3:00 pm - 4:00 pm
Webinar Online Event, OH United States

Join BioOhio members BIO, Aon, and Chubb on March 29 at 3:00 pm for a discussion on preparing for cyber perils, as well as the launch of the new BIO Network Security and Privacy Liability Panel. The pervasiveness of Cyber in day-to-day business operations introduces serious legal, business and reputational risks to life sciences companies. Increasing regulations and customer, employee and shareholder expectations implore firms to identify, mitigate and transfer cyber risk. Click here to register. After the Webinar: Click here to learn how…

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April 2018

NAMSA Webinar: Understanding the Use & Value of Biocompatibility Standards for Medical Devices under ISO 10993-1

April 11, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA on April 11 for the webinar Understanding the Use & Value of Biocompatibility Standards for Medical Devices under ISO 10993-1. Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan. In today’s world, however, the simplicity of the above process is increasingly questioned given the…

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Webinar: Securing Seed Funding: Support for Women in Science

April 12, 2018 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Are you an entrepreneur or researcher working to advance innovation biotech or healthcare technology and finding the funding landscape to be complex? The National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) may be able to assist through its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. On Thursday, April 12, 2018, 2:00 – 3:00 p.m. ET, join NCATS and the Association for Women in Science (AWIS) for a webinar about SBIR and STTR…

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Webinar: Introduction to Additive Manufacturing

April 17, 2018 @ 1:00 pm - 2:30 pm
Webinar Online Event, OH United States

In this session, MAGNET will introduce various concepts related to 3D Printing/Additive Manufacturing. In it, presenters will walk through the AM process from design to finished part, discuss AM industry trends and its relative place in the manufacturing ecosystem, and end with a few general use case applications.

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R&Q Webinar: EU MDR – Proactive Post-Market Surveillance

April 24, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for April's free Intelligence Series webinar: EU MDR – Proactive Post-Market Surveillance: The requirements and staff it will take to do it. The session will be on Tuesday, April 24ᵗʰ from 1:00pm - 2:00pm EST. The presentation slides, webinar recording, and Q&A will be made available to registrants - whether you can attend the live presentation or not. Webinar details The EU MDR lays out requirements for a proactive post-market surveillance system that that inputs into the ongoing…

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May 2018

R&Q Intelligence Series Webinar: CERs – Tips, Tricks, and Lessons Learned

May 22, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar CERs – Tips, Tricks, and Lessons Learned on May 22 at 1pm. You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs. And now come the questions... What do these requirements really mean? Why are we doing this? How are we going to get this all done? In this webinar, you’ll get the clinical…

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June 2018

Webinar: Overview of Guidance & Standards for Elemental Impurities, presented by Smithers Rapra

June 14, 2018 @ 10:00 am - 10:45 am
Webinar Online Event, OH United States

BioOhio member Smithers Rapra, a world leader in rubber, plastics, and composites analysis, has opened registration for the final installment of its three-part webinar series providing an overview on selected United States Pharmacopeia (USP) general chapters, featuring Dr. Daniel Norwood, Independent Senior Consultant, and Michael Creese, Manager, Chemical Analysis. The final webinar, titled “Overview of Guidance & Standards for Elemental Impurities,” will take place on Thursday, June 14, at 10 am EST. Dr. Norwood and Mr. Creese will deliver a…

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Webinar: Demystifying Apprenticeships

June 27, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join The Ohio Manufacturers' Association for Demystifying Apprenticeships, a webinar on Wednesday, June 27 from 10:00 - 11:00 a.m. ‘Registered Apprenticeship’ is a hot topic among manufacturers, lawmakers, and educators. Despite the national attention, many are still asking: What exactly is registered apprenticeship and how can it benefit manufacturers? In this webinar, you’ll hear from Ohio’s State Apprenticeship Administrator, as well as two group model apprenticeship sponsors about how registered apprenticeships have been successfully implemented across the state. Details and…

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Webinar: The Design and Development of Preclinical Studies

June 28, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA for the webinar The Design and Development of Preclinical Studies on June 28 at 10AM. Within the medical device development industry, preclinical studies are on the rise as medical technologies become progressively complex. While biocompatibility testing is required for novel devices, biological effects can increasingly be addressed by pairing materials characterization with risk assessment activities. However, the assessment of critical preclinical endpoints are often only achievable through the utilization of in vivo studies, and preclinical studies are typically required to address…

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July 2018

Webinar: AdvaMed presents Global Trade in the Age of Trump

July 11, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Don't miss this webinar from BioOhio partner AdvaMed on July 11 at 10AM. Join Beth Baltzan of American Phoenix Trade Advisory Services and Ralph Ives of AdvaMed for an overview of the current international trading system. During this complimentary webinar, you will learn how U.S. trade policy is formed and receive a structural overview of the global trading system. This introductory webinar is a precursor to a special session on trade at The MedTech Conference in Philadelphia this September: “Is…

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Webinar: Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety

July 12, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Medical device organizations that manufacture products that involve patient contact are almost always required to perform some level chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential…

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Webinar – FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder

July 25, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States + Google Map

On May 30, 2018, the FDA announced the launch of the Devices to Prevent and Treat Opioid Use Disorder Challenge to spur the development of medical devices, including digital health and diagnostic devices, to help combat the opioid crisis and to help prevent and treat Opioid Use Disorder—a serious health condition which can be a devastating outcome of opioid drug use. The FDA’s Center for Devices and Radiological Health will accept applications for this challenge from June 1 through September 30, 2018. Medical…

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Webinar: How to Effectively Navigate Radiation Sterilization Validation Scenarios

July 26, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Radiation sterilization has new and updated methods for conducting terminal sterilization validations on devices intended to be exposed to either gamma or electron beam irradiation processes. For example, flexibility of the minimum terminal sterilization dose can now be determined based on a product’s microbial population (bioburden). NAMSA invites you to join us on July 26, 2018 (10-11 AM ET) as Ed Arscott, Senior Product Development Strategist, discusses the following: Testing approaches for radiation sterilization validation, including New and modified methods…

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2018 MHSRS Webinar for Biosciences, presented by G2G

July 31, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio partner G2G for their annual MHSRS webinar on July 31 at 12pm. Once you RSVP, you will receive the link to participate in the webinar. MHSRS Background: The MHSRS (Military Health System Research Symposium Conference) is the largest military medical conference of the year. It is in Kissimmee, FL on August 20-23, 2018. Many DoD, DHA and USAMRMC leadership, program managers, clinicians, researchers, academia and industry attend and are eager to learn about medical innovations and ways to collaborate…

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August 2018

Webinar: EU MDR 2017/745: Optimizing Clinical Evaluation Reports Within the Medical Device Lifecycle

August 7, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

As there are less than two years remaining prior to the MDR enforcement, it is critical that EU device manufacturers prepare now for conformity by May 2020. In this webinar, NAMSA’s Manager of Medical Writing and Regulatory Services (EMEA), will examine the requirements listed in the MDR and MEDDEV 2.7/1 Rev 4, and discuss why device manufacturers shall not consider the CER a mandatory document for NBs or authorities, but rather as a crucial tool for a smooth transition for MDR and beyond.…

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Webinar: Making Youth Engagement Part of Your Workforce Strategy

August 9, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

We know you need workers today. What about in five years from now? Ten? Working with youth can help ensure you have a viable and diverse workforce for long-term success. The Alliance for Working Together Foundation (AWT) will share lessons learned over more than ten years of working to improve public perception and create awareness about opportunities in manufacturing. Our presenter will discuss why helping schools connect STEM to careers will help the manufacturing talent pipeline and offer avenues for…

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ShareVault Webinar: “The Nuts and Bolts of Selecting a CRO”

August 15, 2018 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio partner ShareVault for the webinar: The Nuts and Bolts of Selecting a CRO on August 15 from 2-3pm. The clinical trial industry is highly regulated with a complex landscape. Contract Research Organizations (CROs) are a big part of any strategic product development life cycle. Sponsoring companies of new drugs, devices or biologics may outsource all or part of their clinical research. These service providers or vendors range from niche to full service capabilities, which a sponsor of a clinical…

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Webinar: Arbitration in Life Sciences Transaction Disputes

August 15, 2018 @ 4:00 pm - 5:00 pm
Webinar Online Event, OH United States

Presented by BioOhio member, Squire Patton Boggs Arbitration is rapidly becoming the preferred dispute resolution mechanism for the life sciences sector. There are numerous reasons for this focus. The most obvious is that increasingly, M&A transactions are cross-border (e.g., Takeda’s acquisition of Shire). The often complex and lengthy process involved in life science transactions can give rise to disputes at various stages. In this live one-hour webinar, senior counsel, Haig Oghigian, F.C.I.Arb., will discuss how to navigate these disputes from…

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Webinar: The New ISO 10993-1:2018 – What Now?

August 27, 2018 @ 10:30 am - 11:30 am
Webinar Online Event, OH United States

This webinar, presented by Don Pohl (Principal Product Development Strategist, NAMSA), will take a look at the major changes introduced within ISO 10993-1:2018, and also discuss how manufacturers can efficaciously prepare for implementation of these new requirements. Questions to be addressed include: What are the changes to the General Principles Applying to Biological Evaluation of Medical Devices? Is there clarification on when chemical characterization testing may or may not be needed? What are the categorization changes and how does that…

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September 2018

R&Q Webinar: Wait, what? That’s a combination product?

September 25, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on September 25 at 1pm. Is there a medical device hiding in your product portfolio? Combination products – defined in 21 CFR 3.2(e) – are often stealthy, and once you’ve discovered one, do you know what to do? This webinar will answer those questions and more. After defining what constitutes a combination product and examining other vital basics, we’ll share numerous case studies that shed light on how other companies of different sizes…

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Charles River Webinar: Integrated Approaches: Leveraging In Vitro and Ex Vivo Tools for Oncology Research

September 27, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join Charles River for the webinar Integrated Approaches: Leveraging In Vitro and Ex Vivo Tools for Oncology Research on September 27 at 11am. Overview Patient-derived xenograft (PDX) models are a valuable instrument in oncology. In this webinar, we will show how cell-based assays performed with low passage, PDX-derived material serve as cost- and time-effective tools to select appropriate models as well as conditions for in vivo efficacy studies. Join us to learn how an integrated approach based on PDX in vitro,…

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October 2018

G2G’s Post-MHSRS Conference Debrief Webinar for Biosciences

October 2, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

In July, G2G held its Annual MHSRS (Military Health System Research Symposium) Webinar for bioscience and high-tech companies to learn how to take full advantage of the largest military medical conference of the year to advance their medical innovations. After attending the MHSRS in August, G2G is hosting this webinar to share insights and key takeaways gleaned from the conference and talking with DoD, DHA, and USAMRMC leadership and program managers that will help companies align with military research priorities…

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Webinar: The Most Pressing Talent Needs of the Life Science Industry: Highlights from the 2018 CSBI National Workforce Trends Report

October 11, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

With the breakneck speed of new discoveries and shifting global and regulatory environments, the need for the right talent to drive innovation in the life science industry (which includes biotechnology, pharmaceuticals, digital health, medical devices, etc.) is a leading concern of life science employers. The 2018 CSBI Workforce Trends Report identifies the most pressing talent needs of the life science industry and the key trends that are driving talent acquisition. Please join the CSBI Chair and Workforce Committee Co-Chair for…

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NAMSA Webinar: EU MDR – General Safety & Performance Requirements for the Biocompatibility of Medical Devices

October 23, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for the webinar EU MDR - General Safety & Performance Requirements for the Biocompatibility of Medical Devices. Are you preparing to upgrade your device technical documentation to meet the European Union’s (EU) Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements? If so, this webinar will provide best practices and meaningful tips for manufacturers with devices sold under CE marks. NAMSA EMEA regulatory expert, Vincent Legay, will explain how the EU MDR requirements supersede current…

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R&Q Webinar: Understanding EU MDR and the Roadmap to Compliance

October 23, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on October 23 at 1pm. The EU MDR date of application is approaching faster than you might think. With changing schedules and increased scrutiny from the notified bodies, as well as an overwhelming amount of information out there, it can be difficult to understand the impact of the new regulations and determine where and when to start. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more…

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November 2018

IVD Clinical Trials – Essential Components for Product Launch in 2019 & Beyond

November 6, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on 11/6 at 10am. Webinar Description: As in vitro diagnostic (IVD) markets and regulations change, it’s imperative to stay up-to-date on clinical trial components that are required to facilitate efficient, cost-effective market approvals. During this NAMSA-sponsored webinar, Kristin Jones, MS, CCRA (Principal Medical Research Manager), will discuss the essential mechanisms that must be addressed throughout IVD clinical studies regardless of product type or intended market launch territory. Highlighted will be: An overview of…

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Webinar: Ohio’s Medical Marijuana Law: How it Will Work and Workplace Implications

November 13, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Brian Higgins and Rich Moore from Frost Brown Todd will provide an overview of Ohio’s medical marijuana law and some related federal laws. They will then dive into employment-related issues posed by the law. Click here to register for the webinar.

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Cyber Security for Healthcare Businesses

November 13, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio member Warwick for the webinar Cyber Security for Healthcare Businesses on November 13 at 12pm. 64% of organizations are using some form of managed services. Is your healthcare organization part of that percentage? If not, what are you waiting for? Having a fast, compliant and secure IT environment is essential for all businesses and organizations operating in the healthcare industry in order to comply with HIPAA and maintain the critical confidentiality of patient records. Click here to learn more…

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Webinar: Use Ohio TechNet’s Consortium to Build your Talent Pipeline

November 15, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join The Ohio Manufacturers' Association for the webinar Use Ohio TechNet’s Consortium to Build your Talent Pipeline on November 15 at 10 am. Ohio TechNet is a statewide consortium of 27 colleges/universities focused on accelerated training to meet the needs of Ohio’s manufacturers. This collaborative initiative launched with 11 colleges in 2014, training about 2,300 transitioning adults for careers in manufacturing. Participation of additional colleges and universities expands Ohio TechNet’s capacity to recruit and train your future workforce. Join us for this…

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R&Q Webinar: Economic Operators

November 27, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on November 27 at 1pm. The EU MDR extended the responsibilities of those who handle your information and product, and require you have new systems to interact with them throughout the process. In this webinar we will cover the requirements for authorized representatives, importers, and distributors. We'll also cover what you as the manufacturer need to do to ensure that these entities are prepared and ready for implementation. Key webinar takeaways: Your role…

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January 2019

R&Q Webinar: EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

January 16 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

BioOhio member R&Q is teaming up with Greenlight Guru for a webinar you won't want to miss on January 16th at 1pm ET! In May of 2017 the European Union’s Medical Device Regulation came into force and with that came a three year transition time which ends on May 26th, 2020. But despite the fact that we’re over 50% of the way through the transition, there continues to be anxiety and confusion surrounding how to interpret the EU MDR, what it means to…

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NAMSA Webinar: Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers

January 17 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA For the webinar Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers on January 17 at 10AM. Published in 2018, new medical device standard ISO 19227 builds upon previous French Standard NF S94-091 for orthopedics manufacturers. It not only provides guidelines in parallel to ISO 10993 for biological safety, but also further standardizes approaches for orthopedic implant cleaning. This NAMSA webinar, presented by Nicola Revellin, PhD (Sr. Medical Research Scientist—EU Biological Safety & Validation), will explore the impact…

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February 2019

NAMSA Webinar: Understanding Medical Device Reimbursement Fundamentals to Achieve Commercialization

February 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States + Google Map

Join BioOhio member NAMSA for the webinar Understanding Medical Device Reimbursement Fundamentals to Achieve Commercialization on February 20 at 11am EST. Most medical technology entrepreneurs will tell you that in recent years, reimbursement has become as large of a barrier to successful commercialization as regulatory clearance. Medical device manufacturers that do not plan early for reimbursement risk prolonged delays in bringing products to the market as the FDA approval/clearance process is an extremely important, single, sentinel event. In order to maximize…

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Webinar: Applying ‘Making Ohio’ Research to Your Recruitment Efforts

February 21 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Are you interested in learning more about opportunities to build your workforce pipeline? During this session, the Ohio Manufacturers' Association will share the key findings and implications of a multi-phase research assignment commissioned by The Ohio Manufacturers’ Association and executed by the Fahlgren Mortine agency. The objective of the research was to identify opportunities to build a workforce pipeline for the next generation of Ohio manufacturers. The research explores workforce candidates’ attitudes, beliefs, and preferences about the manufacturing industry to…

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G2G Webinar: Military Medical Funding-How it Works & Preparing for MHSRS 2019

February 21 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio member G2G for a webinar on Military Medical Funding-How it Works & Preparing for MHSRS 2019 on February 21 at 12pm. This webinar will give you updates on what is happening with the federal budget process and timing for the coming year, best opportunities for biosciences, and preparation for successful participation in the largest military medical R&D conference hosted by the Military Health System Research Symposium (MHSRS). Submitting an abstract and being selected to present a poster or speak at the…

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R&Q Webinar: What is sufficient clinical evidence to meet the EU MDR?

February 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar What is sufficient clinical evidence to meet the EU MDR? on February 26 at 1 pm. The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address the expectations for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally, we’ll cover requirements for PMS planning and PMS reporting for all…

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March 2019

Aon Webinar: Cyber Risk Landscape and Evaluation Tool for BIO Members

March 6 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio-Bio Business Solutions partner Aon for the webinar Cyber Risk Landscape and Evaluation Tool for BIO Members on March 6 at 2pm. Beyond a loss to employee data or health records, a life science organization cyber breach has the potential to impact compound advancement, impede the ability to secure funding, and halt operations. Aon’s Cyber Quotient Evaluation (CyQu) tool, an online self-assessment, can be the conduit to uncovering vulnerabilities within your organization’s security controls that could lead to a cyber event and understanding…

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VWR Webinar: Designing Novel Fluid Sampling Systems for GMP Operations

March 19 @ 9:00 am - 10:00 am
Webinar Online Event, OH United States

Join BioOhio member VWR for the webinar Designing Novel Fluid Sampling Systems for GMP Operations on March 19 at 9am EST. Sampling is a requirement in every process step of biopharmaceutical manufacturing, with an increasing demand on accuracy the closer it comes to final finish. The webinar demonstrates a 4-step process, to develop a highly efficient and accurate sampling system. Get a deep insight into the lifecycle of product development design: Product conceptualization considerations Engineering design and proof of concept Quality…

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NAMSA Webinar: Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary

March 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on Design Control: Understanding the Benefits of Starting Early and Why it's Necessary on March 20 at 11 am. While design control has been a quality system requirement since 1996, many medical device organizations struggle to understand these requirements, as well as when to start the process and how to maximize the benefits of the system. For example, it is often mistaken that a design control process must be complex to meet the regulatory requirements and to ensure delivery of a…

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R&Q Webinar: Biocompatibility: EU MDR and the changing regulatory landscape

March 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on Biocompatibility on March 26 at 1pm EST. This webinar will dive into the increased specificity of the EU MDR from a biocompatibility perspective and how the revised 10993-1 fits into the new requirements. We will share our experiences from the viewpoint of testing laboratory experts and regulatory consultants with biocompatibility experience from both science and regulatory affairs backgrounds. Our goal is to help you understand the changing regulatory landscape in light of…

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April 2019

NAMSA Webinar: Use of OUS Clinical Data in Medical Device Product Development

April 17 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on the Use of OUS Clinical Data in Medical Device Product Development on April 17 at 11 am. In February 2018, the U.S. Food & Drug Administration (FDA) issued a final rule on an updated regulation pertaining to the acceptance of data from clinical investigations conducted outside the United States (OUS) to support IDEs or submissions (i.e., PMAs). While it is common for medical device manufacturers to utilize OUS clinically applicable data (including clinical…

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R&Q Webinar: EU MDR for Combination Products

April 23 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q on Tuesday, April 23 at 1pm ET for this month's free webinar: EU MDR for Combination Products. Fresh off of their recent Advanced EU MDR and CER Workshops in Minneapolis and Boston, R&Q's Director of Regulatory Affairs Nancy Morrison will be presenting. The rules have changed with Article 117 and more companies will require notified body involvement. This is the first time devices integral to a drug product will require notified body assessment. Although the requirements…

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Webinar: On-ramps & Talent Pipeline Development to Manufacturing Careers

April 25 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join the Ohio Manufacturers' Association for On-ramps & Talent Pipeline Development to Manufacturing Careers, a webinar on Thursday, April 25, 2019 from 10:00 - 11:00 a.m. OMA recognizes a variety of programs that are designed to be on-ramps to manufacturing careers. In this presentation, participants will learn about four programs designed to be development pipelines to Ohio manufacturing careers, including: Career Connections IGNITE: Mastering Manufacturing The Manufacturing Foundation Certificate ApprenticeOhio Tune in to find out how these programs can support…

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NAMSA Webinar: How to Select the Right EU Notified Body for IVDR Compliance

April 30 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on How to Select the Right EU Notified Body for IVDR Compliance on April 30 at 10am EST. The objective of this webinar is to provide manufacturers who intend to market in vitro diagnostic (IVD) products in the European Union (EU) and/or Canada with general guidance on identifying, selecting and approving a designated EU Notified Body, in accordance with the regulatory requirements of the various current Medical Device Directives and the recently published European In Vitro Diagnostic Regulation (IVDR 2017/746). Topics to be covered during this webinar include: The role of an EU Notified Body overseeing the IVD Regulation (2017/746); Current challenges Notified Bodies are facing…

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May 2019

UIDP Webinar: Finding Order in Chaos

May 1 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join Ohio-based The Solution Infusion for the webinar Finding Order in Chaos, hosted by UIDP (University-Industry Demonstration Partnership), on May 1 from 1-2pm EST. This webinar shares an approach for technical problem solving that efficiently and effectively identifies “out of the box” solutions. The approach is particularly effective for large, diverse groups, such as are common in university-industry partnerships. A key element is creation of functional maps which help enroll and focus all team members on the problem to be solved…

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Squire Patton Boggs Webinar: Understanding and Preparing for the California Consumer Privacy Act

May 7 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Effective January 1, 2020, the California Consumer Privacy Act (CCPA) will impose burdensome GDPR-like transparency and individual rights requirements on almost every company that handles “personal information” regarding California residents, regardless of where the business is based. The Act will impact information regarding not only consumers, but also employees and business contacts. Join BioOhio membe Squire Patton Boggs for the webinar Understanding and Preparing for the California Consumer Privacy Act on May 7, 2019, when Elliot Golding, Phil Zender and Ivan Rothman…

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R&Q Webinar: Integrating CERs and Post-Market Surveillance

May 28 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar Integrating CERs and Post-Market Surveillance on May 28 from 1-2pm. CEP, CER, PMS Plan, PMS Report, PSUR and SSCP: With a variety of new requirements detailed in EU MDR, integrating the clinical, regulatory, and post-market documentation is a difficult and confusing task for both small and large organizations. There are overlapping requirements and consistent information needs to be included in a variety of plans and reports. R&Q will explain how the data inputs and…

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June 2019

Breakthrough Supply Chain Performance Virtual Workshop, presented by Xavier Health

June 4 @ 9:00 am - 4:00 pm
Webinar Online Event, OH United States

Join Xavier Health for the Breakthrough Supply Chain Performance Workshop - an interactive, virtual workshop, from the comfort of your home or office. Facilitated by authors of the newly-released Good Supply Practices for the 21st Century, Viliam Kovac (former VP, Roche Diagnostics), Marla Phillips (former Site Head of Quality, Merck), Jack Solomon (former VP, Allergan), and Cynthia Ipach (President, Compliance Insight), Tuesday, June 4, 2019, from 9am-4pm EDT. The expert trainers are Xavier Health Certified Trainers, signifying that they played a…

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AdvaMed Webinar: China Adverse Event and PMS

June 12 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member AdvaMed on June 12 from 1-2pm EDT for the webinar China Adverse Event and PMS. The session will cover China post market surveillance (PMS).  NMPA (CFDA) has started to put more emphasis on post market supervision than ever before. Three key areas will be discussed: adverse events (AE), recalls and overseas inspection.  Two key regulations were issued in the past year on AEs and overseas inspection. We will cover key requirements of the regulations, discuss its implications…

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G2G Webinar: Updates on Non-Dilutive Government Funding Sources and MHSRS 101: An Introduction

June 13 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio partner G2G for the webinar Updates on Non-Dilutive Government Funding Sources and MHSRS 101: An Introduction on June 13 from 12-1pm. Topics Covered: Funding Opportunities for Biosciences from Congress and Agencies Key Timelines and Sources of Government Funding Ways to Access Decision-Makers Overview of the Upcoming MHSRS, Military Health System Research Symposium - the largest annual military medical conference Case Studies on Securing Funding, Policies and Relationships in Government Insider Tips for Success If you cannot attend and are interested in obtaining…

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Council for Affordable Health Coverage Webinar

June 13 @ 3:30 pm - 4:30 pm
Webinar Online Event, OH United States

Join the Council for Affordable Health Coverage (CAHC) for the webinar Binding Arbitration: Government Price Controls Hiding in Plain Sight on June 13 at 3:30pm ET. As policymakers look to enact solutions improving prescription drug access and affordability, some in Washington are championing a misguided, shadowy process whereby third parties would be allowed to set the price of Medicare drugs following a closed-door evaluation. Politicians call this “independent dispute resolution” or “binding arbitration,” but patients know it as something else:…

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NAMSA Webinar: How to Implement an Effective Internal Audit Program

June 19 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA on June 19 from 11am - 12pm EST for the webinar How to Implement an Effective Internal Audit Program. An organization’s internal audit program is more than meeting the requirements of the 21 CFR 820, ISO 13485 or ISO 9001 standards. An effective internal audit program is an essential part of an effective Quality Management System (QMS), and can be a key communication tool in the promotion of continual improvement throughout the organization, as well as provide insight in areas of…

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Best Practices for Biotech Communications Professionals, presented by Business Wire

June 20 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio member Business Wire for the webinar Best Practices for Biotech Communications Professionals on June 20 at 2pm EST. When it comes to your news, urgency and accuracy matter most. Whether you have FDA approval, company updates or an earnings release, getting your news out promptly, securely and widely is key to your public perception and your ability to control the news narrative. We understand that success means aligning your goals and content with your audience. Our account team…

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Application Deadline for mSpire 2019, presented by MAGNET

June 30
Webinar Online Event, OH United States

Join BioOhio member MAGNET for mspire: Northeast Ohio's only pitch challenge exclusively for product-focused entrepreneurs and small manufacturers. What is mspire? mspire is Northeast Ohio's only pitch challenge exclusively for product-focused entrepreneurs and small manufacturers. Why should I apply? Finalists are given resources and guidance specifically geared to their unique situation. We work hard to ensure that winners are given the help that they need to build their businesses. Who should apply? The event is open to any entrepreneur or…

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July 2019

GCP Annual Meeting Online Show

July 10 @ 12:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio member Greater Cleveland Partnership on Wednesday, July 10 at noon for the GCP Annual Meeting online show to hear more about the work they are doing on behalf of the business community and how you too can get engaged in driving the region’s economic development strategy. Greater Cleveland Partnership is the largest metropolitan chamber of commerce in the country and they have a strong track record of taking on game changing projects that have propelled this region forward.…

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NAMSA Webinar: MDR 10.4: What Should We Really be Doing to be Prepared?

July 19 @ 10:30 am - 11:30 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for the webinar MDR 10.4: What Should We Really be Doing to be Prepared? on July 19 at 10:30 am. In this webinar, NAMSA’s regulatory and testing experts will discuss the restricted materials compliance sections of the Medical Device Regulation (MDR), specifically Section 10.4-Substances. As outlined in this guidance, manufacturers are to reduce risk posed by substances or particles that may be released from a device; however, what does this really mean in practice, and how might sponsors…

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SafeWhite/HaloSmile On-Air @ QVC

July 19 @ 11:00 pm - 11:30 pm
Webinar Online Event, OH United States

Mark your calendars for July 19 at 11pm EST! BioOhio member HaloSmile will be on-air on The QVC Channel and online at QVC.com selling eight (8) Natural White applications for the price of six (6)! HaloSmile is a new way to get a whiter smile. The smile cosmetic is a unique formulation that creates a light and tasteless layer over the surface of your teeth—covering stains rather than removing them. This means no pain or sensitivity. And just like makeup,…

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G2G’s Webinar: MHSRS 201: Maximizing Participation and Engaging the Military to Access Funding and Collaborations

July 23 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio member G2G for the webinar MHSRS 201: Maximizing Participation and Engaging the Military to Access Funding and Collaborations on July 23 at 12pm. Dial-in to learn more about MHSRS 2019 and how you can prepare to participate and access key program managers even if you cannot attend. G2G will give other updates on funding opportunities currently in play and ways to stay on top of the process. Background on MHSRS: The Military Health System Research Symposium (MHSRS) Conference…

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NAMSA Webinar: Biostatistics in IVD Clinical Research – What Can Make or Break your Product’s Commercialization

July 30 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for the webinar Biostatistics in IVD Clinical Research - What Can Make or Break your Product's Commercialization on July 19 at 10:30 am. As an integral part of IVD clinical research, a sound biostatistical strategy is essential to achieving commercialization. Regardless of the intended market, end user or purpose of your product, there is one design element that needs to be the center of your strategy. Learn how to understand your assay’s precision profile and how to apply it to…

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September 2019

NAMSA Webinar: Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management

September 4 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member organization NAMSA for an informative webinar.  Updates to ISO 14971: “Application of Risk Management to Medical Devices,” and its companion Technical Report ISO TR 24971: “Guidance on the Application of ISO 14971,” are soon to be released. Within the ISO 14971 updates, eight major changes are being made to the standard to address risk management of medical devices from inception to post-production. These modifications will impact both the risk management of new product development, as well as…

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R&Q CER Virtual Workshop

September 12 @ 12:00 pm - 3:00 pm
Webinar Online Event, OH United States

Get ready for the CER-EU MDR insight you’ve been waiting for from BioOhio member R&Q with the R&Q CER Virtual Workshop. Inspired by positive feedback from R&Q webinars and in-person workshops this year, R&Q is offering up a free and one-of-a-kind online event this fall unlike anything we’ve seen from the medical device industry. It’s all happening Thursday, September 12th from Noon – 3pm ET. Sign up now and get the free workshop on your calendar. Please note that R&Q…

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