Join us for a 90 min webinar focused on the new EU Medical Device Regulations (MDR/IVDR) which represent the single largest regulatory change in the EU in decades. This program will highlight what the regulatory changes are, how these changes will affect your business, and what you can do to better prepare.
Agenda topics include:
- What are the changes in the regulations?
- How will these changes affect research and development, and what impact will there be on (i) high risk devices, (ii) drug/device combinations, and (iii) mobile and telemedicine?
- How will the new framework affect market access?
Dr. Lincoln Tsang, PhD, JD
Partner, Arnold & Porter Kaye Scholer
Dr. Lincoln Tsang, formerly a senior regulator qualified as a lawyer, and a pharmacist with post-graduate training in toxicology and cancer pharmacology, concentrates his practice on regulatory, compliance, enforcement and public policy matters affecting the life sciences industry: pharmaceuticals, biotechnology, medical devices, in vitro diagnostic devices, cosmetics and food. Dr. Tsang has extensive experience in advising clients in developing strategies for research and development, product life-cycle management, product acquisition, and risk and crisis management, as well as internal investigations. He regularly represents clients before various regulatory bodies on matters concerning approval, advertising and promotion, manufacture, vigilance, product recall and health technology appraisal for medicines and medical devices.
Jacqueline Mulryne, JD
Counsel, Arnold & Porter Kaye Scholer
Jackie Mulryne advises clients in the life sciences, medical devices, cosmetics and foods sectors, and has a broad practice providing regulatory compliance and public policy advice. She advises on UK and EU law, and has experience with a range of regulatory issues that arise throughout the product life cycle, including borderline classification, clinical research, authorization and assessment, advertising and labeling, and pricing and reimbursement. She has assisted a number of life science and medical device companies in developing and implementing cross-border regulatory action and compliance programs, with internal investigations, and with challenges to the decisions of regulatory authorities. She also works on product liability matters on behalf of pharmaceutical and medical device companies, and has assisted on large multiparty actions, and in defending individual personal injury and product liability claims.
The webinar will take place from 1:00-2:30pm ET on October 4, 2017.
All registrants will receive login instructions within 24 hours of the start time. All registrants will receive the recording and slides for the presentations, even if unable to participate live.