Press Announcements

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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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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European GDP Association launches newly designed website

The European GDP Association has launched its newly designed website to provide members and those interested with information and practical tools. The website now comes in a cleaner design - helping visitors to find information faster and easier. 

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Urgent ECA/APIC/European QP Association Meeting on Nitrosamine Impurities announced

Since EU authorities were notified about the presence of N-nitrosodimethylamine in Valsartan batches of a Chinese API manufacturer in June 2018, more and more cases of drug substance and drug product batches contaminated with Nitrosamines have come up. Consequently there is a need to discuss all relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances and drug products

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The new ubiquitous term in aseptic manufacturing - Contamination Control Strategy

With the publication of the draft revision of Annex 1, a term emerges that has not previously been present in this intensity in the guideline - "Contamination Control Strategy".

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GMP Conferences by Topics

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