Since the end of the comment period for the new Annex 1 on July 20, we have been frequently asked which comments have been submitted, where the ECA/EQPA Task Force thinks changes need to be made and when we expect a final version.
Every year in spring, participants, speakers, exhibitors and exhibition visitors normally meet at the Pharma Congress. This year, however, the situation required everybody involved to rethink: instead of networking in the conferences, at the exhibition and at the traditional social event on site, the Pharma Congress reached congress participants and visitors Live Online - with complete success.
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.
The call by the German Robert Koch-Institute (RKI) as well as other institutions in the field of disease surveillance and prevention to reduce social contacts in the private, professional and public environment and to recduce travel activities also has consequences for ECA events.
The European QP Association's (EQPA) IMP Working Group, representing more than 1.500 Qualified Persons (QPs) in the Investigational Medicinal Products (IMP) area and professionals in similar functions from across Europe and beyond, has announced a change in its group leadership.