Day 2 04 December 2024

Navigating reliance: Practical applications and case studies in Asia

Rewatch the full session below or on Zoom. The full presentation from Day 2 is here.

Session objectives:

Look at current experience with reliance procedures in the South-East Asia & Western Pacific region.
Share best practices and lessons learned so far in implementing reliance.
Discuss recommendations about different documents that can be used to facilitate reliance.

Moderator
- Alice Chee Regulatory Consultant, PhAMA (Pharmaceutical Association of Malaysia)
Presenter
- Wenzel Asprec Food-Drug Regulation Officer III (Senior Pharmaceutical Dossier Assessor), Food and Drug Administration (FDA) Philippines
- Céline Bourguignon Head of Regulatory Policy and Intelligence for Greater China Intercontinental and Emerging Markets, GSK
Panelists
- Noraisyah Mohd Sani Senior Principal Assistant Director, National Pharmaceutical Regulatory Agency
- Yee Hoo Looi Deputy Director, Health Sciences Authority, Singapore

Session objectives:

Discuss how reliance can be implemented for PACs and what tools are available to streamline reliance in this area.
Highlight findings from literature, industry surveys and available data to illustrate the complexity of the current global PACs framework.
Address challenges and propose solutions to further implement reliance for GMP inspections.

Moderator
- Stephan Roenninger Director Quality External Affairs, Amgen (Europe) GmbH representing IFPMA
Presenter
- Isabelle Colmagne-Poulard Head of International Global Regulatory & Scientific Policy, Merck (Merck KGaA Darmstadt)
- Hamada Sherif Chairman associate for updating & developing registration systems & general manager for human drug registration, Egyptian Drug Authority (EDA)
Panelists
- Stephen Farrell Director, GMP Clearance, Manufacturing Quality Branch (MQB), Therapeutic Goods Administration (TGA), Australia
- Achiraya Praisuwan Professional Pharmacist (GMDP inspector), Thai Food and Drug Administration

Interested to learn more about the speakers?