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Regulatory WG Workshop

November 24 - 25, 2023

The DCVMN Regulatory Working Group convened for a workshop in the vibrant city of Singapore, delving deep into pivotal regulatory and clinical discussions over two enriching days!

This gathering was a platform for robust exchanges featuring a comprehensive exploration of PAC and TRS 993 Annex 4. The invaluable sharing of experiences with NGS by DCVMN members was met with keen interest and constructive insights from revered regulators, including Koen Brusselsmans from ScienSano, NRA Belgium, and Gibran Horemheb Rubio Quintanares from PEI NRA Germany.

Looking toward the horizon of 2024, the Working Group took proactive steps, initiating a SWOT analysis of the regulatory landscape. This insightful exercise paved the way for the formulation of a strategic working plan for 2024 aimed at propelling advancements in Post Approval changes across the DCVMN.

The collaboration, insights, and forward-thinking discussions during this workshop underline DCVMN’s commitment to fostering innovation and ensuring regulatory harmonization in the domain of vaccines.

Stay tuned for more updates as we continue our journey into the future of Regulatory Affairs!

hashtag#RegulatoryAffairs hashtag#InnovationInVaccines hashtag#WeConnectToProtect

1. Adaptive Design P Neels
2. CHIM trials- P Neels
3. Real Wold Evidence_ Kaat Bollaerts
4. Real World Evidence_Anvisa status_ Cleber Gomes
5. NGS Introduction_Pieter Neels
6. NGS Regulatory requirements _ Koen Brusselmans
7. NGS_Singapour_ Gibran_PEI
8. NGS Zydus Chozhavel Rajanathan
9. NGS SII_ Dr Naik
10. PAC_Status in Latam_Sebastian Comellas
11. PAC situation in Brazil_C Gomez & M Cruz
12. PAC Asia-Africa_Subhodeep Chakraborty