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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)
Sonja Beken, PHD, MSC
Chair 3Rs Working Party, EMA; Coordinator Non Clinical Evaluators, Federal Agency for Medicines and Health Products, Belgium
Implementing the 3R’s – Regulatory Perspective
Natasa Zamurovic, DRSC
TA Head Immunology Preclinical Safety, Novartis, Switzerland
3 R's: Understand the Safety Risks Early and Reduce Animal Use for Early Development Programs
Christophe Lahorte
Head of National Innovation Office and Scientific-Technical Advice Unit, Federal Agency for Medicines and Health Products, Belgium
Scientific Advice: Clinical Trial Related Multi-National Scientific-Regulatory Advice within the European Medicines Regulatory Network: Quo Vadis?
Gunilla Andrew-Nielsen
Head of Clinical Trials, Swedish Medical Products Agency (läkemedelsverket), Sweden
Panelist
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