CMC Documentation + Post-Approval Changes/Variations

- Pharmaceutical Development: traditional approach or quality by design?
- Process Validation Guideline
- Quality risk management - from a regulator's perspective
- Impurities - latest regulatory novelties
- Quality of excipients
- Post approval changes - regulatory flexibility?

Do you work in regulatory affairs, CMC or quality assurance? Then you shouldn't miss out on this event. During the conference very practical questions will be addressed and strategic information on future CMC trends will be provided.

May I invite you to an intensive discussion on new developments such as
- the process validation guideline
- quality risk management
- impurities
- regulatory flexibility with regard to post approval changes,
and much more?

I am very much looking forward to seeing you at the conference!
Kind regards
Dr Henriette Wolf-Klein
Department manager pharma + healthcare

Termin

Datum: 04.03.2015
Ort: Steigenberger Metropolitan
Poststr. 6
-60329 Frankfurt
Preis: 1.790,00 EUR zzgl. MwSt.
 

Zielgruppe

This conference will be of interest to all those working in the pharmaceutical industry dealing with CMC topics. Particularly those working in the following departments will benefit from this event:
- Marketing authorisation/regulatory affairs/CMC
- Quality assurance/quality control/analytics
- Production

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