20 Years ECA Academy

From 6-7 June 2019 in Heidelberg, Germany

Join us and celebrate the 20 years anniversary of ECA in Heidelberg at the 8th European GMP Conference
- Meet speakers from US FDA, EU GMP Inspectorates and Pharmaceutical Industry to hear the latest GMP Trends
- Receive the latest ECA Guidance Documents at no costs!

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Pharma Congress 2019

From 9-10 April 2019 in Düsseldorf, Germany
- More than 60 Speakers from pharmaceutical companies and GMP Inspectorates
- Case Studies from Novartis, Roche, Boehringer Ingelheim, Sanofi, Bayer, Pfizer and many more
- 3 GMP/FDA Conferences – create your own agenda!

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Acknowledged GMP/GDP Certification

Highly qualified personnel is crucial in the pharmaceutical industry. The ECA Certification scheme with 14 continuous education programmes trains you adequately.

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GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

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ECA – Your GMP/GDP Information Source

With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.

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Latest GMP News

Mar 21

Brexit: GDP Updates for Import Activities and Air Freight ...

MHRA has published new Guidance for import and air freight activities. One is introducing a new function, the Responsible Person (import) - RPi.

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Mar 21

Hard Brexit: Liability Risk for Carriers ...

In the case of a "Hard Brexit", delays in import and export are to be expected. This will affect contracts and liability.

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Mar 21

Delivery of not ordered goods - what to do? ...

A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?

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Mar 21

FDA´s Pilot Program for Established Conditions ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

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Mar 21

Is the review of the Audit Trail required in Clinical trials? ...

The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?

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Mar 21

Short Format Development Safety Update Report ...

Not all trials are the same in terms of risk. Therefore, the MHRA proposesd a simpler and shorter form in lieu of a full Development Safety Update Report, giving a significant time saving.

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Upcoming Conferences and Courses

Radiopharmaceuticals – Quality, Safety and GMP Requirements

Vienna, Austria
26-27 March 2019

Radiopharmaceuticals – Quality, Safety and GMP Requirements
Handling Changes and Variations

Copenhagen, Denmark
26-27 March 2019

Handling Changes and Variations
Quality Control Compliance Manager

Vienna, Austria
27-29 March 2019

Quality Control Compliance Manager
View more Conferences and Courses

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Efficient Batch Record Design and Review

Recommended Event

Vienna, Austria

28-29 May 2019

Efficient Batch Record Design and Review

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