E-workshop on Regulatory Pathways and Changes in Vaccine Testing

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