These 2 webinars and face-to-face workshop aimed to determine what is needed to facilitate alternative methods validation, implementation and regulatory acceptance, including global harmonization, of non-animal based batch release testing for veterinary vaccines.
After the first two webinars where the current opportunities were presented from a scientific and technical perspective and where the perspective from European, North and South America, and Asia stakeholders was shared, the Brussels workshop focused on challenges to be addressed and concrete actions or future projects that will be pushing for further methods’ implementation and regulatory acceptance.
RECORDINGS AND PRESENTATIONS:
EUROPE & AMERICAS WEBINAR PROGRAM:
Welcome:
Laura Viviani, AFSA
Joris Vandeputte, IABS-EU
Overview about implementation and regulatory acceptance of non-animal testing in veterinary vaccines:
Angela Walker, USDA
Laurent Mallet, 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):
Terrie Jo Hamtak, MSD AH
Angela Walker, USDA
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, MHRA (VAC2VAC)
Anne Thomas, Zoetis (VAC2VAC)
Closing remarks:
Joris Vandeputte, IABS-EU
Rick Clayton, HealthforAnimals
Laura Viviani, AFSA
ASIA WEBINAR PROGRAM:
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
Catherine Lang, 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 Singh, 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
BRUSSELS WORKSHOP PROGRAM: PART 1
Welcome
Laura Viviani, AFSA
European Medicine Agency 3Rs in veterinary vaccines
Sonja Beken, FAMHP
Elisabeth Balks, PEI
EDQM’s 3R Achievements for Veterinary Vaccines
Catherine Milne, EDQM
Perspective on the 3Rs implementation
Geetha Srinivas, USDA
Current status and perspectives on 3Rs opportunities in IP monographs for veterinary vaccines
M. Kalaivani, Indian Pharmacopoeia Commission
ASEAN and Indonesia experiences for implementation 3Rs in Vaccine batch release testing and production
Liys Desmayanti & Ni Made Ria Isriyanthi, Ministry of Agriculture of Indonesia
Lesson learnt from Vac2Vac
Joris Vandeputte & Carmen Jungbäck, IABS-EU
Industry investment on alternative methods
Catrina Stirling, HealthforAnimals
BRUSSELS WORKSHOP PROGRAM: PART 2
Opening and summary of the morning session
Joris Vandeputte & Carmen Jungbaëck, IABS-EU
Collaborative session. Methods development and implementation. Which opportunities can be prioritized?
Moderators:
Botond Siklodi, Ceva
Paul Stickings, NIBSC
Collaborative session. Promote regulatory alignment. How to facilitate product specific acceptance and resilience
Moderators:
Catrina Stirling, Zoetis
Catherine Milne, EDQM
Wrap up & next steps
Laura Viviani, AFSA
Joris Vandeputte & Carmen Jungbaëck, IABS-EU
Closing remarks