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Innovation of Mature Products – New Uses for Old Products
Session Chair(s)
Nick Sykes, MS
Policy Advisor
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)
Opportunities to Protect Innovation after Expiry of Intellectual Property Rights
Genevieve Michaux, LLM
King & Spalding International LLP, Belgium
Partner, Life Sciences
Challenges to Overcome When Obtaining a New Marketing Authorisation for a Mature Product – A Case Study
Sylvia Grace Marianne Jean Lobo, PhD, RPh
Pfizer, United Kingdom
Senior Director, Regulatory- Global Established Products
Regulatory Challenges and Considerations
Joris Langedijk
Utrecht University, Netherlands
Panel Discussion
Peter Bachmann
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Deputy-Head, European Union and International Affairs
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