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NEW ACTIVE SUBSTANCES AND KNOWN ACTIVE SUBSTANCES – DESIGNATION, IMPLICATIONS

Track:
New and Known Substances - how to fit the rules to needs

Day & Time:
March 27, 9:00AM - 10:30AM (Central European Standard Time)

Session Number:
1505

Room Number:
5AB

Type:
Session

Title:
NEW ACTIVE SUBSTANCES AND KNOWN ACTIVE SUBSTANCES – DESIGNATION, IMPLICATIONS

Chair(s):
Carla Schoonderbeek, LLM
Partner in Law Firm
Hoyng Monegier, Netherlands

Description:
The subject for the session is Regulatory Data Protection (RDP) for New Active Substances (NAS), Known Active Substances (KAS) and combination products. As these issues usually concern matters of both law and science, the session will focus both on the application of the law and the application of the relevant scientific tests. The session aims to address the issues from a legal, regulatory and public policy perspective in an interactive manner. The speakers will make presentations focusing on the relevant legal provisions as well as the guidance, application in practice and as yet unresolved issues. This will be followed by a panel discussion between the audience and the speakers.

Presentation(s) & Speaker(s):
NAS: Designation and Consequences (legal aspects)
Carla Schoonderbeek, LLM
Partner in Law Firm
Hoyng Monegier, Netherlands

NAS: Designation and Consequences (regulatory aspects)
Henk F. Schuring, PhD
Director, Regulatory Affairs EU
Genzyme Europe B.V., Netherlands

KAS: Fresh Periods of RDP for Known Active Substances and RDP for Combination Products
Barbara Lange
Senior Legal Counsel
Novartis Pharma AG, Switzerland

Decision Makers and Unresolved Issues
Lidia Retkowska-Mika, LLM
Director Legal DPT
Office For Registration of Med. Products, Medical Devices and Biocides, Poland