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IPEC Europe

Supporting the interests of pharmaceutical excipient developers, producers, distributors and users.

News Detail / Event Detail

08-11-17

APV seminar on 'Definition of starting materials – scientific and regulatory aspects'

APV is glad to invite you to its seminar on pharmaceutical professionals in R&D, as well as in quality control/assurance and regulatory affairs departments of pharma-ceutical industry and API manufacturers.

 

Taking place on 8 November, this seminar will cover all relevant aspects concerning the definition of starting materials:

 

• ICH Q11 and other relevant guidelines
• Requirements from authority’s perspective
• Experiences after submissions and consequences for drug substance
   development and lifecycle management
• Scientific data in regulatory submissions
• Starting materials for biologicals

 

Please follow this link to download the final programme as a PDF file.  

 

Don't miss this unique chance to share experiences with colleagues and authorities. Register right now by clicking here.

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