Event Details
- Summit
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This event has been completed
Pharmaceutical Regulatory Summit Asia - August 03, 2015 - August 06, 2015
- Grand Copthorne Waterfront Hotel
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Singapore, Singapore
- Introduction
- The 8th annual event will address these concerns with an increased focus on crafting regulatory strategies for efficient drug approvals in each jurisdiction, as well as identifying regulatory pathways for key bioproducts across Asia .
Key Themes for 2015
Latest Country-Focused updates, Regulatory Convergence trends, Adaptive licensing and Future Trends
Key Bioproduct-Focused Regulatory Advice and Strategies in various SEA Key markets
Clinical Regulatory Strategies such as Overcoming Challenes in NDAs, MRCTs and Bridging studies across the region
Effective Management of Quality Processes and Compliance – QbD & QbR, CMC studies, and Post Approval Variations
Post Market Surveilance and Evaluating Drug Safety & Efficacy Essentials
Implementing an Effective Global Regulatory Strategy (GRS) and Global dossier submission Best Practices - Useful Links
- Reference link 1
- About Organiser
- Informa business
- E: Yvonne.Leong@ibcasia.com.sg
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