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November 2017

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 @ 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 @ 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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February 2018

Battelle Webinar: Insidious Cardiotoxicity

February 16 @ 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 @ 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 @ 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 @ 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 @ 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 @ 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 @ 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 @ 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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NAMSA Webinar: Leveraging Post-Market Data to Support EU MDR Compliance

March 28 @ 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 @ 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 @ 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 @ 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 @ 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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R&Q Webinar: EU MDR – Proactive Post-Market Surveillance

April 24 @ 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 @ 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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OAI Lunch and Learn: CWRU Siegal Lifelong Learning Program

May 24 @ 12:00 pm - 1:00 pm
Ohio Aerospace Institute, 22800 Cedar Point Road
Cleveland, OH 44142 United States
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Join BioOhio members Ohio Aerospace Institute and Case Western Reserve University for a lunch and learn event on May 24 at 12pm. The event will feature the CWRU Siegal Lifelong Learning Program, offering courses, lectures and workshops for adults of all ages who wish to pursue their love of learning in Northeast Ohio.  Agenda: 12-12:15 p.m. Introductions and Overview of CWRU Siegal Lifelong Learning Program Continuing Professional Studies, Brian Amkraut, Executive Director, The Laura and Alvin Siegal Lifelong Learning Program, CWRU 12:15 p.m.…

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