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Opportunities for Regulatory Dialogue to Accelerate Innovation in the EU
Session Chair(s)
Ursula Busse, PHD, MBA
CMC Regulatory Affairs Advisor
Self employed, France
Veronika Jekerle, PHD, RPH
Head of Pharmaceutical Quality
European Medicines Agency, Netherlands
The recently published EU Pharmaceutical strategy puts enhanced regulatory dialogue and readily adaptable regulatory procedures to accelerate the development of novel therapies as flagship initiatives. To achieve this it will be necessary to look at how industry, regulators and academia engage with each other in the course of the discovery and development of potential therapies to provide clarity or share perspectives that can enable rapid decision making and ultimately speed up the development process. This session will share a range of novel therapeutic platforms and delivery systems of the future, share examples of the benefits of early and continued dialogue in the ATMP area to facilitate a roundtable discussion on potential opportunities to adapt the procedures for gaining regulatory contributions to the development of new medicines.
Speaker(s)
New Drug Platforms and Delivery Systems
Anders Holmén, PHD, MSC
Astrazeneca, Sweden
Vice President and Head of Pharmaceutical Sciences, BioPharmaceuticals R&D,
Benefits of an Enhanced Dialogue Between Industry and Regulators: Learnings from the ATMP Journey
Kowid Ho, PHARMD
F. Hoffmann-La Roche Ltd, Switzerland
Pharma Technical Regulatory Policy
How Can Academics Effectively Engage with Regulators?
Teun van Gelder
Leiden University Medical Center, Netherlands
Panelist
Nick Lee, PHD
Health Products Regulatory Authority (HPRA), Ireland
Executive Pharmaceutical Assessor