About 13th Annual Pharma Regulatory Affairs Asia

In parallel with newly emerging diseases, new drug development will continue to happen in the Asia Pacific and projected to reach USD62.5 billion by 2026. The regulatory Affairs role will get more complexed and challenged working in Asian markets that are governed by diverse and rigorous regulatory and safety requirements.

The 13th Annual Pharmaceutical Regulatory Affairs returns to address past, present and anticipated future regulatory affairs roles and requirements in developed and developing regions in APAC; be it R&D, market access and authorisation, CMC requirements, QA, clinical, new therapeutics, and overall scope of product development that integrates technology, analytics, and regulatory insights.

Part of the 7th Annual PharmaCon Asia, meet and network with industry leaders and get up-to-speed on the latest insights and case studies across 4 co-located events.

 2020 Highlights

  • Global regulatory priorities and compliance
  • Country-based regulation updates
  • The regulatory framework for advanced therapy products – CAR-T, cell and gene therapies
  • Generics, biosimilars, OTC, combination therapies and biologics
  • Global and regional efforts in standardising and regulating disruptive markets’ technologies
  • Drug pricing and reimbursement regulations in diverse ASEAN
  • Case studies: Japan’s re-pricing rule on APIs, China drug bulk-buy plan and regulatory strategy
  • Successful case studies of eCTD, timeline, scope and pros and cons in Asia
  • Regulatory risk management on pharmacovigilance – pre and post-marketing
  • Regulatory requirements and views on a life-cycle approach to quality and safety of pharmaceutical products
  • GAMP and compliance
  • Legal and regulatory requirements on distribution and marketing in APAC
  • Regional regulatory evaluation of medical device oversights
  • Insights on the supply chain, labelling and packaging
  • Outsourcing the regulatory affairs function in advanced technology and processes markets
  • Regulatory strategy on data protection & privacy in the digitalisation of Pharma
  • Holistic views on Regulatory Information Management (RIM) and Regulatory Intelligence Database (RID)