Press Announcements 2020

First Live Online Pharma Congress great Success

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.

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How to document a Product Transfer? Get Example Templates for free

As a participant of the GMP Live Online Training "Product Transfer" you will receive electronic example documents, templates and guidelines for site change projects.

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How to use Established Conditions efficiently? FDA Speakers will show examples

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.

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Survey about electronic equipment qualification documentation

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.

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GMP/GDP Online Trainings

Face-to-face events are out of the question in the present situation. However, online training options are a very good alternative. Learn more about the different online training options offered by the ECA.

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ECA GMP News Service on Twitter

Get the latest GMP trends quickly and easily anytime and anywhere - with the ECA's service on Twitter.

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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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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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