PHARMACEUTICALS 2011 - Annex 13 GMP guide - Webinar By ComplianceOnline

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Category Pharmaceuticals,conference,event,Webinar

Deadline: February 17, 2011 | Date: February 17, 2011

Venue/Country: Palo Alto, U.S.A

Updated: 2011-02-14 18:10:27 (GMT+9)

Call For Papers - CFP

The European Commission has passed and published the final version of Annex 13 ("Investigational Medicinal Products") to the EC GMP Guide. The new Annex comes into force in July 2010. It calls for special attention in areas to GMP conformity for investigational medicinal product by personnel working on clinical trials. Compliance can be achieved especially thorough training, some possible changes in processes and revision of some GMP standard operating procedures. These enhanced requirements reflected in the revision of Annex 13 are part of the strict regulations now in force in the European Community.

The session will review the guideline to cover the key areas of compliance including: The role of the "Qualified Person", Packaging, labeling, reconciliations that should take place for each product and each production stage, and Comparator product requirements etc.

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