Press Announcements 2020

European GDP Association - Advisory Board Change

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.

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Adjusted Cancellation Conditions

In light of the effects COVID-19 has on our work, our social life and our travel behaviour, we have adjusted our cancellation policy to meet with the changes this pandemic has caused.

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ECA Validation Group launches new Website

The ECA's Validation Group has re-launched its website. With a cleaner design members and those interested can now find valuable information faster and easier.

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Be Involved in Annex 1 Revision

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.

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GMP/GDP Online Trainings

Face-to-face events are completely out of the question in the present situation. However, online trainings are a good alternative to stay up to date and to become familiar with current and new GMP/GDP requirements.

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Important Information for ECA Academy Course Participants regarding the Consequences of the Coronavirus SARS-CoV-2 Pandemic on Events

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.

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European QP Association announces Change in IMP Group Leadership

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.

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ECA and its Interest Group European QP Association Named as Stakeholders for Final Consultation of EU GMP Annex 1

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

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New: English translation Aide memoire Qualification and Validation for Inspectors

GMP legislation and guidelines are occasionally not very specific. The pharmaceutical industry is seeking more concrete interpretations, though, especially coming from regulators. Such an example is the guide "Aide memoire Qualification and Validation - Basic Requirements" for inspectors.

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GMP Conferences by Topics

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