Date :
Place : Switzerland, Zurich
Contact Person:Paula Edwards
Description:
Course "European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements and other Agencies" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines. EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission,Deadline for abstracts/proposals : 1st August 2017
Organized By :New York Events List
Keynote Speakers : David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by dev
Conference Highlights :Areas Covered in the Session: EMA and many NCAs are involved in the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of GMP. The legal basis and main features of the various types of authorizations Evaluate the various options for the submission of a marketing authorization application for regulatory strategy for the compo
Venue :Hilton Zurich Airport, Hohenbühlstrasse 10, 8152 Opfikon, Switzerland
Check the event website for more details.