- 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!
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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In June 2018 already, the International Council for Harmonisation (ICH) announced the coming issuance of a new ICH Guideline on continuous manufacturing. Now, the ICH has released further news about the planned content of the new guideline ICH Q13.
In December 2018, the FDA published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?