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Global Regulatory Convergence- State of Play and Outlook for the Future
Session Chair(s)
Iman Barilero, PHARMD, PHD
Vice President, Regulatory Science & Pharmacovigilance
Agenus, United States
Spiros Vamvakas, MD
Scientific Advior on Human Medicines
European Medicines Agency, Netherlands
The session will provide examples of initiatives undertaken by regulators to support innovative drug development and regulatory science-based decision making, and will present initiatives with enhanced patient perspectives on the medicines R&D processes of the treatment development life cycle. We will also explore the views from a patient group, FDA, and EMA on the impact of regulatory convergence and ways forward to maintain sustainable global drug development and an effective regulatory process.
Speaker(s)
EMA-FDA Collaboration in the Context of Scientific Advice, Including the Parallel Qualification Procedures and ‘PRIME Breakthrough’
Tomas Salmonson, DrMed, PHD
Critical Path Institute, Netherlands
Robert Hemmings, MSC
Critical Path Institute, Netherlands
ICH E17 Multi Regional Trials and Addendum E6
Armin Koch, DRSC
Hannover Medical School, Germany
Head, Institute of Biometry
Conversion from a Patient Engagement Perspective at Key Decision Points of Drug Development: How Can We Find a Common Approach to Supporting Innovation and Drug Development - and Possible Areas of FDA-EMA Collaboration?
Dimitrios Athanasiou, MBA
WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece
Patient Advocate