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MAINTENANCE OF MEDICINAL PRODUCTS WITH KNOWN ACTIVE SUBSTANCES – VARIATIONS
Session Chair(s)
Susanne Winterscheid, PMP
Head of Licensing Division 3
Federal Institute for Drugs and Medical Devices (BfArM), Germany
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.
Speaker(s)
Success of Grouping and Work sharing
Susanne Winterscheid, PMP
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Head of Licensing Division 3
Case Study of a Centralised Product Highly Active in Product Maintenance Activities
Beatrix Marianne Metzner, PhD
Merck KGaA, Germany
Director - Head of Global Regulatory Oncology EU I
Impact of the Pharmacovigilance Legislation on Variations for Generic Products
Beata Stepniewska, MPharm
Medicines for Europe, Belgium
Deputy Director , Head of Regulatory Affairs
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