1 year after the implementation of Annex 1

The new Annex 1 published on August 25, 2023, is focused on reducing the risks of product contamination in the manufacturing processes of a sterile product, especially when it is an aseptic process and not terminal sterilization. It includes regulatory updates, changes in other chapters of the GMP, use of tools described in the ICH Q9 and Q10 guidelines, aims to eliminate ambiguities and considers advances in new technologies.

The conference will address challenges, learning and experience gained one year after the implementation of Annex 1.

Recognized experts in their field will share their experience and knowledge and give details on what difficulties they have encountered in implementing the new requirements and how they have dealt with them. At the end of the day, you will be able to exchange your concerns and ideas with industry professionals during a round table to better understand the problems and innovative solutions. In this round table, the problems raised by the attendees will be discussed anonymously (attendees are encouraged to propose, beforehand or during the day itself, the issues they would like to be addressed) and the most appropriate options for their resolution will be debated.

Program available soon