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2020 ISPE Annual Meeting & Expo


NA20CENOV1/KEYNOTEWED - Global Regulatory Town Hall - The Impact of a Pandemic on Harmonization and Convergence


Nov 4, 2020 9:00am ‐ Nov 4, 2020 11:00am

Expiration Date: Nov 30, 2021

Description

Global Regulatory Town Hall - The Impact of a Pandemic on Harmonization and Convergence|The impact of the current pandemic will have far-reaching effects on global regulations, inspections, and related efforts toward regulatory harmonization and convergence. The discussion during this year’s Town Hall will center around COVID-19-related implications for global regulatory alignment. The pandemic has shed new light on the need for developing internationally harmonized standards and standards convergence to facilitate greater coordination and oversight of medical products. The current environment has not only exacerbated existing weaknesses in the supply chain, but also has let to postponed inspections, increased scrutiny of products shipped internationally, and highlighted inconsistencies in the regulatory processes from agency to agency. Representatives from USFDA, MHRA, ANVISA, WHO, ANSM, PIC/S, and Health Canada have been invited to join the live discussion.

Speaker(s):

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

Session Leader(s):

Moderator(s):

  • Timothy J. Watson, PhD, Executive Director & Team Leader, CMC Advisory Office, Pfizer Inc.

Panelist(s):

  • David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, MHRA
  • Lucinda F. Buhse, PhD, Acting Senior Advisor for OPQ, CDER/FDA
  • Rick Friedman, Deputy Director, Office of Manufacturing Quality, CDER/FDA
  • Abdelaali Sarakha, PhD, Senior GMP Inspector, Annex 1 Rapporteur, French Health Products Safety Agency (ANSM)
  • Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization
  • Gustavo Mendes Lima Santos, General Office of Medicines and Biological Products, GGMED, ANVISA

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