CMC Documentation & Quality-Related Variations
Organization: FORUM Institut für Managemnt Insitut
Venue: Pullman Cologne
|Event Date/Time: Feb 21, 2013 / 8:30 am - (GMT +1:00 hours)||End Date/Time: Feb 22, 2013|
•Quality control of drug products/substances - the updated regulatory framework
•Variations: Revision of the classification guideline, post-approval change management
•Update on ASMF and CEP
•Update on genotoxic and metal impurities
•Quality challenges in biotech products
This conference addresses the needs of regulatory affairs and quality assurance co-workers in the pharmaceutical industry who need a detailed CMC regulatory update. It discusses qualityrelated questions from the IMPD to the CTD compilation, to quality changes/variations.
May I invite you to a regulatory update on
•ICH Q8, Q9, Q10, Q11
•the revised variation classifi cation guideline
•the revised variations stability guideline
•the ASMF guideline
•the genotoxic and metal impurities guideline
and much more?
I am looking forward to meeting you.