FDA has started an Established Conditions Pilot. At ECA's Live Online Conference ICH Q12 Product Life Cycle Management from 15-16 September 2020 case studies (for process and product) from the pilot will be presented by FDA Speakers. Click here to read more.
Wouldn´t a fully electronic documentation sytem work for both parties (supplier and customer) in qualification projects? This we would like to find out - and would thus appreciate it if you took a few minutes to answer some questions.
The European GDP Association has announced a change on the Authority Advisory Board. Johanna Linnolati from the Finnish Medicines Agency FIMEA decided to leave the board. Dr Daniel Müller, who accepted his nomination recently, takes her place.
The ECA and the European QP Association are both named as official stakeholders by EU Commission to comment on Annex 1. A Task Force has been established to prepare the commentation. In order to involve the members of the ECA and the EQPA, a questionnaire was prepared.