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E-workshop on Regulatory Pathways and changes in Vaccine Testing

April 27 - 29, 2020International (WebEx)

DAY 1
Access the Registration (Dr. Dellepiane) recording
Access the Regulatory Pathways (Dr. Dellepiane) recording

DAY2
Access the Validation acceptance implementation 3Rs (Laura Viviani) recording

DAY 3
Access the Special 3Rs considerations for a COVID19 vaccine (Laura Viviani) recording
Access the Replacement of the Rabbit Pyrogenicity Test (Laura Viviani) recording
Access the Pertussis Serological Potency Test (Laura Viviani) recording

Documents

Agenda – E-workshop on PACs & CMC 3Rs
Speakers booklet – E-workshop on PACs & CMC 3Rs
Pre-reading: Challenges for the reigstration of vaccines in emerging countries
Pre-reading: Opportunities for improving access to vaccines in emerging countries through efficient and aligned registration procedures
Pre-reading: Guidelines on procedures and data requirements for changes to approved vaccines
Pre-reading: Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies
Pre-reading: Collaborative procedure between the WHO Prequalification Team and national regulatory authroties in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines
Pre-reading: Regulatory Acceptance and Use of 3R Models
Pre-reading: Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies
Pre-reading: G-protein based ELISA as a potency test for rabies vaccines
Pre-reading: The Human Whole Blood Pyrogen Test-Lessons Learned in Twenty Years
Pre-reading: Achieving scientific and regulatory success in implementing non-animal approaches to human and veterinary rabies vaccine testing
Pre-reading: Alternatives to Animal Use for the LAL-Assay
References
Presentation 1 Day 1 Registration
Presentation 2 Day 1 Regulatory Pathways
Presentation Day 2 Validation acceptance implementation 3Rs
Presentation 1 Day 3 Updates RPT and rabies
Presentation 2 Day 3 PSPT project
App Form Abstract
Model Application form
Suggested template for alignment of module 1
WHO TRS 996 annex 08
1_lviviani_val_accept_implement_recording.mp4
2_lviviani_qna_and_covid_opportunities_recording.mp4
3_lviviani_rpt_bet.mp4
4_lviviani_pspt_trim.mp4
One Pager Summary Report