MAINTENANCE OF MEDICINAL PRODUCTS WITH KNOWN ACTIVE SUBSTANCES – VARIATIONS

Track:
Known Active Substances

Day & Time:
March 5, 2:00PM - 3:30PM

Session Number:
1003

Room Number:
D201/D202

Type:
Session

Title:
MAINTENANCE OF MEDICINAL PRODUCTS WITH KNOWN ACTIVE SUBSTANCES – VARIATIONS

Chair(s):
Susanne A. Winterscheid, PMP
Head of Project Management of Licensing Division 3
BfArM, Germany

Description:
Experiences with the maintenance of medicinal products by variation procedures are presented from different point of views: Authority representatives will present statistics on grouping and work sharing. Industry representatives will show examples on the efforts and necessary actions in keeping product licences up-to-date. Furthermore, the impact of the new pharmacovigilance legislation on the maintenance of medicinal products will be discussed.

Presentation(s) & Speaker(s):
Success of Grouping and Work sharing
Susanne A. Winterscheid, PMP
Head of Project Management of Licensing Division 3
BfArM, Germany

Case Study of a Centralised Product Highly Active in Product Maintenance Activities
Beatrix Marianne Metzner, PhD
Director - Head of Global Regulatory Oncology EU I
Merck KGaA, Germany

Impact of the Pharmacovigilance Legislation on Variations for Generic Products
Beata Stepniewska, MPharm
Deputy Director , Head of Regulatory Affairs
European Generics Medicines Association EGA, Belgium