Description
Comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs)
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Industry experts will cover the regulatory landscape and the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges. The differences between GMP for ATMPs and conventional therapies will be discussed, as will the requirements for clinical trials and the preparation of the IMPD. Advice on the specific transportation requirements of these products will also be addressed.
This programme will be of benefit to all those involved with or considering developing an ATMP.
Pharmaceutical Development of ATMPs Training Course (ipi.academy)
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