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.
On 20 February 2020 the European Commission published the final draft of the EU GMP Annex 1. The previous draft had been published after a fundamental revision end of 2017 - and had resulted in more than 6,000 comments. This is why the European Commission will proceed differently with the Final Draft of Annex 1. Read more about the upcoming Stakeholder Consultation