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March 2018

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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June 2018

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

June 14 @ 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 @ 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 @ 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 @ 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 @ 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 @ 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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2018 MHSRS Webinar for Biosciences, presented by G2G

July 31 @ 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 @ 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 @ 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 @ 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 @ 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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