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Annex 1: Manufacture of Sterile Products

Nov 5, 2020 11:45am ‐ Nov 5, 2020 1:15pm

Credits: None available.


Annex 1: Manufacture of Sterile Products | Eudralex Vol 4 Annex 1 draft has been released for comments ending May 2020. Share Industry comments supported by ISPE. as recognized organization for collecting comments. The session aims to introduce comments submitted to European Commission by ISPE, discussion on these topics. Regulators from around the world have been invited to discuss these comments or having regulators giving presentations on the draft and comments.


  • Qiao Bobo, PhD, Division Director, Office of Product Quality, CDER/FDA
  • Roberto Conocchia, Senior GMP Inspector, European Medicines Agency (EMA)
  • Matthew J. Davis, Senior GMP Inspector, Therapeutic Goods Administration
  • Jean-Francois Duliere, Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
  • Paul A. Gustafson, 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada
  • Alan Moon, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Abdelaali Sarakha, PhD, Senior GMP Inspector, Annex 1 Rapporteur, French Health Products Safety Agency (ANSM)
  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.


Credits: None available.

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