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August 2017

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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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 @ 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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