The programme 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. Comparison of 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 included.
This programme will be of benefit to all those involved with or considering developing an AMTP.
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.
