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.
Senior GMP Inspector, Annex 1 Rapporteur,
French Health Products Safety Agency (ANSM)