New GMP Regulations and Inspection Programs in Asia Pacific

Session 203
Regulatory Track

China, India, and the ASEAN (Association of Southeast Asian Nations) region are rapidly growing markets for new and generic drugs. As part of their efforts in strengthening the regulatory systems to ensure product quality, health authorities in these Asia Pacific countries have begun to upgrade their Good Manufacturing Practices regulations to be aligned with those in advanced countries in recent years.

At the conclusion of this session, participants will be able to:

Realize the implications of current product developments in the Asia-Pacific region
Recognize the urgency of understanding the changing GMP regulations and programs in the region
Learn the status of implementation of GMP regulations in the different Asia-Pacific markets
Apply lessons learned from inspection experiences of other companies

Leaders

Who should attend?

Manufacturing
Service providers
Suppliers
Regulators

Communities of Practice/Members who will benefit:

API
Critical Utilities
Investigational Products
Operations Management
Process/Product Development
Project Management
Sterile Products Processing
Sustainable Facilities