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2020 ISPE Europe Annual Conference


EU20CESEP1/SES303 - Regulatory Panel Session: Distant Assessment on GMP and Inspection Reliance


Sep 17, 2020 4:00am ‐ Sep 17, 2020 5:00am

Description

Regulatory Panel Session: Distant Assessment on GMP and Inspection Reliance |

Speaker(s):

  • Mark Birse, Vice President, Technical, Parexel
  • Bernd Boedecker, Ex-EU GMP Inspector, Trade & Industry Inspection Agency
  • David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, MHRA
  • Domenico Di Giorgio, Director, Inspection & Certification Department, AIFA Agenzia Italiana Del Farmaco
  • Anne Hayes, Inspection Manager, Health Products Regulatory Authority
  • Monika Mayr, Scientific Administrator Manufacturing & Quality Compliance, EMA
  • Jacques Morenas, Technical Advisor of the Inspection Division Director, ANSM (Agence Nationale De Securite Du Medicament Et Des Produits De Sante)
  • Christian Schaerer, Head Inspectorate, Division of Inspectorate & Licences, Swissmedic
  • Vladislav Shestakov, Director, Deputy Head of Russian State GMP Inspectorate, State Institute of Drugs and Good Practices
  • Robert W. Tribe, AP Regulatory Affairs Advisor, ISPE

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