About 13th Annual Pharma Regulatory Affairs Asia

2019 Key Discussions

  • 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!

“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