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: Presentation slides
Laurent Mallet, EDQM
Corinne Philippe, HealthforAnimals: Presentation slides
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: Presentation slides
Angela Walker, USDA: Presentation slides
Break
Rabies in vitro potency test (incl. 5 mins Q&A):
Catrina Stirling, Zoetis (VAC2VAC): Presentation slides
Florence Cliquet, ANSES (France), WOAH: Presentation slides
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: Presentation slides
General toxicity test on Clostridials (incl. 5 mins Q&A):
Silvia Fragoeiro, MSD AH: Presentation slides
Cl. Tetanus in vitro potency test (ELISA) (incl. 5 mins Q&A):
Paul Stickings, MHRA (VAC2VAC): Presentation slides
Anne Thomas, Zoetis (VAC2VAC): Presentation slides
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: Presentation slides
Catherine Lang, EDQM: Presentation slides
Corinne Philippe, HealthforAnimals: Presentation slides
Animal batch safety test: A case study on test deletion and (yet to be) global harmonization. (incl. 5 mins Q&A):
Laura Viviani, AFSA: Presentation slides
Brajesh Singh, MSD AH/India: Presentation slides
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: Presentation slides
Break
Rabies in vitro potency test (incl. 5 mins Q&A):
Catrina Stirling, Zoetis (VAC2VAC): Presentation slides
Florence Cliquet, ANSES (France), WOAH: Presentation slides
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: Presentation slides
General toxicity test on Clostridials (incl. 5 mins Q&A):
Silvia Fragoeiro, MSD AH: Presentation slides
Cl. Tetanus in vitro potency test (ELISA) (incl. 5 mins Q&A):
Paul Stickings, NIBSC (VAC2VAC): Presentation slides
Ann Thomas, Zoetis (VAC2VAC): Presentation slides
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: Presentation slides
Elisabeth Balks, PEI: Presentation slides
EDQM’s 3R Achievements for Veterinary Vaccines
Catherine Milne, EDQM: Presentation slides
Perspective on the 3Rs implementation
Geetha Srinivas, USDA: Presentation slides
Current status and perspectives on 3Rs opportunities in IP monographs for veterinary vaccines
M. Kalaivani, Indian Pharmacopoeia Commission: Presentation slides
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: Presentation slides
Lesson learnt from Vac2Vac
Joris Vandeputte & Carmen Jungbäck, IABS-EU: Presentation slides
Industry investment on alternative methods
Catrina Stirling, HealthforAnimals: Presentation slides
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