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The 3R’s: Reinvigorating, Repurposing and Reclassification
Session Chair(s)
Daniel O'Connor, DrMed, PHD, MS
Medical Assessor
Medicines and Healthcare products Regulatory Agency, United Kingdom
Reinvigorating older drugs includes repurposing and reclassification (switch), creating both opportunities and challenges for industry and regulators, whilst maximising the potential public health benefits of medicines for patients. Hear from different experts, with lessons learned from repurposing in oncology, regulators taking up the challenge and switch by design, the proactive structured approach to reclassification.
Learning Objective : Participants will learn over reclassification of a new substance in the EU, understand the constraints and hear advice on how companies can best prepare for a switch
Speaker(s)
Reinvigorating Older Drugs in Oncology
Pan Pantziarka, PHD
The Anticancer Fund, Belgium
Senior Research Manager
Reclassification and Repurposing - Regulatory Initiatives
Keith McDonald, MSC
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Deputy Director, Licensing Division
Switch by Design - Challenges and Opportunities for Reclassification
Christelle Anquez-Traxler, PHARMD
AESGP, Belgium
Regulatory and Scientific Affairs Manager