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How to De-risk Early Development?
Session Chair(s)
Mireille Muller, DRSC, PHD, MSC
Regulatory Policy & Intelligence Director
Novartis Pharma AG, Switzerland
Olga Kholmanskikh Van Criekingen, MD, PHD
Clinical assessor
Federal Agency for Medicines and Health Products, Belgium
Initiatives to de-risk early development of medicines are essential for improving the efficiency, safety, and success rate of medicines development. It benefits both patients and entire development ecosystem by accelerating the availability of effective treatments and decreasing risk associated with medicines development. In this session you will learn the latest initiatives such as 3Rs, Early target de-risking, CT-SNSA to de-risk development and enforce sustainability, innovation, and collaboration.
Speaker(s)
Implementing the 3R’s – Regulatory Perspective
Sonja Beken, PHD, MSC
Federal Agency for Medicines and Health Products, Belgium
Chair 3Rs Working Party, EMA; Coordinator Non Clinical Evaluators
3 R's: Understand the Safety Risks Early and Reduce Animal Use for Early Development Programs
Natasa Zamurovic, DRSC
Novartis, Switzerland
TA Head Immunology Preclinical Safety
Scientific Advice: Clinical Trial Related Multi-National Scientific-Regulatory Advice within the European Medicines Regulatory Network: Quo Vadis?
Christophe Lahorte
Federal Agency for Medicines and Health Products, Belgium
Head of National Innovation Office and Scientific-Technical Advice Unit
Panelist
Gunilla Andrew-Nielsen
Swedish Medical Products Agency (läkemedelsverket), Sweden
Head of Clinical Trials