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Innovation of Mature Products – New Uses for Old Products
Session Chair(s)
Nick Sykes, MS
Policy Advisor, Regulatory Strategy, EFPIA, Belgium
Multiple challenges exist for the development of products that have been on the market for many years; often these products are operating in a multisource market. Such challenges include the regulatory acceptability of new and existing data, and legal protection for new uses. Session in development
Speaker(s)
Genevieve Michaux, LLM
Partner, Life Sciences, King & Spalding International LLP, Belgium
Opportunities to Protect Innovation after Expiry of Intellectual Property Rights
Sylvia Grace Marianne Jean Lobo, PhD, RPh
Senior Director, Regulatory- Global Established Products, Pfizer, United Kingdom
Challenges to Overcome When Obtaining a New Marketing Authorisation for a Mature Product – A Case Study
Joris Langedijk
, Utrecht University, Netherlands
Regulatory Challenges and Considerations
Peter Bachmann
Retired from Head International Liaison Office and Conferences, Executive Depart, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Panel Discussion
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