EU Medical Device Regulation: Your Questions Answered

With the European Union (EU)’s new Medical Device Regulation (MDR) taking effect in May 2020, device manufacturers transitioning to the EU MDR face a host of questions. Among them are:

• Is it possible to avoid compliance with the MDR?
• When should I be compliant?
• How will this affect my new product development?
• How does this affect my products currently on the market?
• Which notified body should I use?
• How will Brexit affect my company?
• Where do I begin?

This webinar will address these and other critical questions and will pave the way to strategic planning for compliance with the EU MDR. New product development teams will discover that the timeline for MDR is extremely limited compared to existing products on the market. Post-market surveillance teams will discover the implications of the Post-Market Clinical Follow-up requirement and the European Database on Medical Devices.

In this webinar, our featured speakers will review the importance of: 

• Having a robust regulatory strategy
• Conducting a gap analysis of current technical documents and products
• Investing in budgetary and human resources
• Communicating with your Notified Body
• Adopting to MDR within the allotted regulatory timelines

Speakers

Nach Davé, RPh, MS, Vice President, Development Strategy, Premier Research

Mr. Nach Davé oversees Premier Research’s regulatory affairs service offerings across its broad range of therapeutic focus areas, bringing to his position more than 20 years of experience in the pharmaceutical and contract research industries. He previously served the company as Director of Regulatory Affairs and rejoined Premier Research after two years as Senior Director of Regulatory Affairs at PRA Health Sciences.

He also led clinical and regulatory affairs at Maxx Orthopedics, a developer of orthopedic medical devices, and has held roles in clinical operations, business development, strategic consulting and medical affairs at companies such as Merck, Bristol-Myers Squibb, Aventis Pharmaceuticals and Mitsubishi Pharma America.

Mr. Davé holds a Master’s degree in drug regulatory affairs from Long Island University and a Bachelor’s degree in pharmacy from the Philadelphia College of Pharmacy and Sciences. He is a registered pharmacist in the state of New Jersey.

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John Pappan, MA, MS, Director, Regulatory Affairs, Medical Device & Business Strategy, Premier Research

John Pappan is a seasoned executive regulatory affairs professional who focuses primarily on project management and regulatory compliance within the medical device, pharmaceutical and healthcare industries. John has both academic and professional experience in medical device regulatory affairs as well as pharmaceutical and healthcare administration.

A vital component of his professional career in regulatory affairs is to formulate strategies for regulatory submissions and build multidisciplinary teams to resolve regulatory hindrance. John works to assure strategic planning and preparation of 510(k)’s, premarket approvals (PMA)’s, CE Marking and International Registrations. He also resolves regulatory concerns that arise via deficiency letters, product complaints, adverse events, recalls and oversees remediation activities to maintain regulatory compliance. He is well-versed in managing both internal and external regulatory audits. He also has professional experience in implementing the new EU MDR.

John’s core expertise is to bring “safe and effective”  healthcare products and services from new product development to global market transfer and commercial release. He has worked with regulatory authorities and healthcareprofessionals from the US Food and Drug Administration, US Department of Health, EU Notified Bodies and Competent Authorities, Health Canada, Australia’s Therapeutic Good Administration (TGA), China’s State Food and Drug Administration (CFDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and other international authorities of Latin America, Asia-Pacific and the Middle East. John also has directorship and graduate academic experience in teaching regulatory affairs to students pursuing a PhD in Pharmaceutics, a Doctor of Pharmacy and Master’s of Science in Pharmacology and Toxicology, Industrial Pharmacy, Cosmetic Science and Drug Regulatory Affairs.

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