overview

Regulatory Affairs professionals and business managers involved in compliance face ongoing challenges of global and local policy change, and interpretation, to make sure business is not disadvantaged. Ongoing compliance backed up by emergence of new regulatory initiatives serve as constant reminders of the importance of this function.

Now into its 12^th year, this high level forum on regulatory affairs will address new Government initiatives, current industry bottlenecks and required compliance strategies. Hear case studies and real world experiences from peers and experts from across the globe to shape your own strategy.

“Event was well run, interesting topics and speakers were of good to high quality and caliber”

Sue Choong, Group Head of Regulatory and Pipeline Strategy, Inova Pharmaceuticals

In Discussion

• Managing the continued challenges in eCTD and eSubmissions
• Reginal progress on Cell and Gene Therapy products registration and regulation
• FDA Guidelines on Oncology Clinical Trials Makeover
• FDA Device Inspections Program FY19 –inspection and compliance
• Working with India’s revised rules on New Drugs and Clinical Trials
• Streamlining Regulatory Strategies for Licensing, Submission, Approval and Market Access
• Packaging and Labelling compliance
• Medical device regulations in EU and impact on Combination Products
• Drug pricing compliance and price transparency laws
• Pharma competition law and market access regimes
• Site compliance and regulatory requirements for pharma manufacturing
• Regulations on third-party operation management
• RegTech trends and responding to the impact of digitalisation
• Plus Case studies, real world examples and round tables with experts!

6^th PharmaCon Asia

With 4 co-located events across the Pharma value chain and the ONLY event of its kind, PharmaCon Asia will bring to you the full spectrum of the drug development and commercialisation value chain.

3rd Accelerating Clinical Trials in Asia >>
12th Pharma Regulatory Affairs Asia >>
3rd Pharma Market Access and Pricing Summit Asia >>
2nd Digital Pharma Summit >>