Pharmaceutical Development of ATMPs

This course has been designed to provide a comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs).

Industry expterts 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.

Benefits of attending:

• Understand the GMP requirements for clinical trials in US and Europe
• Gain a practical insight into other markets
• Determine critical quality attributes
• Develop a successful QC strategy
• Examine the major differences between GMP for ATMPs and conventional therapies
• Overcome potential pitfalls when manufacturing cells
• Discuss multi-manufacturing sites for autologous products
• Consider stability issues
• Examine risk analysis for biological materials and understand Annex 16
• Gain an introduction to GMO approval requirements

This seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.