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 12th 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.
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!