network. experience. benefit.

ECA - The new EU Annex 1 Draft

25. April 2018


This is why you may want to attend this conference:

  • You get to know the content of the revised EU GMP Annex 1.
  • Inspectors and pharmaceutical operators discuss the consequences of the changes for the operational processes.



  • The new EU GMP Guide Annex 1
  • New terminology used in the Annex 1 draft
  • Pharma Industry’s perspective on the revision of EU GMP Annex 1
  • Environmental Monitoring / Media Fills – new challenges
  • Discussion: Annex 1 revision – challenges for the industry?



  • James Drinkwater, The Pharmaceutical & Healthcare Sciences Society
  • Dr. Friedrich Haefele, Boehringer Ingelheim Pharma
  • Arjan Langen, MSD Animal Health
  • Dr. Jean-Denis Mallet, ECA & Former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS
  • Dr. Daniel Müller, GMP Inspector, Local Authority of Baden Württemberg
  • Dr. Beate Reutter, GMP Inspector Local Government Schleswig-Holstein
  • Alexandra Stärk, Novartis Pharma


Revision of EU Annex 1


PDF der ECA-Konferenz The new EU Annex 1 Draft

Informieren Sie sich auch über den zeitlichen Ablauf im Gesamtzeitplan.