Day 2 - Asia Regulatory Conference

07:30 - 09:00 CET / 17:30 - 19:00 AEDT

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

09:00 - 10:30 CET / 19:00 - 20:30 AEDT

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.

Navigating reliance: Practical applications and case studies in Asia