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2020 ISPE Annual Meeting & Expo


SES305 - Annex 1: Manufacture of Sterile Products


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

Expiration Date: Nov 30, 2021

Description

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.

Session Leader(s):

  • Jean Francois Duliere, Pharmaceutical Senior Expert, Chair ISPE France Affiliate, Consultant, Chair ISPE France Affiliate

Moderator(s):

  • Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.

Speaker(s):

  • Abdelaali Sarakha, PhD, Senior GMP Inspector, Annex 1 Rapporteur, French Health Products Safety Agency (ANSM)

Panelist(s):

  • Qiao Bobo, PhD, Division Director, Office of Pharmaceutical Quality, CDER/FDA
  • Roberto Conocchia, Senior GMP Inspector, European Medicines Agency (EMA)
  • Mattew Davis, Senior GMP Inspector, Therapeutic Goods Administration (TGA)
  • Paul A. Gustafson, Senior Corporate Regulatory Compliance and Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB) Health Canada / Government of Canada
  • Alan Moon, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)

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