Asia Webinar
The webinar aims to outline the state-of-the-art non-animal approaches for veterinary vaccines batch-release testing. It includes information on the state of the deletion of obsolete safety testing, and about the current initiatives taken so far by European and Asian stakeholders on 3Rs implementation and regulatory acceptance.
This webinar is part of a series of events, webinars and a face-to-face workshop, to act as a collective venue of discussion and alignment on current and future opportunities to facilitate the implementation and global regulatory alignment of new non-animal batch release testing.
Agenda:
Welcome:
Laura Viviani, AFSA
Carmen Jungbäck, IABS-EU
Overview about implementation and regulatory acceptance of non-animal testing in veterinary vaccines:
Mariette Van Den Berg, Australian Pesticides and Veterinary Medicines Authority
Emmanuelle Charton, EDQM
Corinne Philippe, HealthforAnimals
Animal batch safety test: A case study on test deletion and (yet to be) global harmonization. (incl. 5 mins Q&A):
Laura Viviani – AFSA
Brajesh Sing – MSD AH/India
Regulatory batch release testing of veterinary vaccines. The view from the Chinese regulatory agency. (incl. 5 mins Q&A)
Wang Li Jong, Director of China Institute of Veterinary Drug Control*
Break
Rabies in vitro potency test (incl. 5 mins Q&A):
Catrina Stirling, Zoetis (VAC2VAC)
Florence Cliquet, ANSES (France), WOAH
EDQM BSP130 – Validation of cell-based assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccines (incl. 5 mins Q&A):
Botond Siklódi, Ceva
General toxicity test on Clostridials (incl. 5 mins Q&A):
Silvia Fragoeiro, MSD AH
Cl. Tetanus in vitro potency test (ELISA) (incl. 5 mins Q&A):
Paul Stickings, NIBSC (VAC2VAC)
Ann Thomas, Zoetis (VAC2VAC)
Closing remarks:
Carmen Jungbäck, IABS-EU
Rick Clayton, HealthforAnimals
Laura Viviani, AFSA