Pharmaceutical Regulatory Affairs Summit - FDA Expedited Programs, Orphan Drug Designation, and US Pediatric Strategies
The FDA has enacted many laws that strive to spur innovation in the development of therapies for patients in need, and bring these therapies to patients faster, specifically in areas where there is unmet medical need, serious and life threatening conditions, and pediatric therapies. These pathways have had a significant impact on both the Agency and industry, and while the full impact will not be known for several years, they carry substantial implications for regulatory affairs professionals now. This Summit is a convergence of regulatory affairs professionals that seek to gain training, strategies, and best practices in the areas of FDA Expedited Programs, Orphan Drug Designation, and US Pediatric Strategies.
Who Should Attend:
Pharmaceutical and Biotech VPs, Directors, and Managers of:
- Regulatory Affairs
- Scientific Affairs
- Clinical Affairs
- Quality Assurance
This summit will also be of interest to CROs, Regulatory Consultants, and Law Firms
Key Takeaways:
- Understand which product classes can benefit most from FDA Expedited Programs including Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review
- Evaluate the risks, benefits, and challenges of developing a drug with an expedited or orphan designation
- Gain strategies to expedite development of companion diagnostics for breakthrough therapies
- Analyze the components needed to sustain safe, ethical, and successful pediatric research
- Hear innovative and novel research methods currently being used in pediatric drug development
- Learn the impact on the future of pediatric drug development from the changes to BPCA and PREA under FDASIA
Call for Papers: Submit Abstract for Presentations
The Pharmaceutical Regulatory Affairs Summit is now accepting abstract submissions for 2015!
Deadline is November 7, 2014.
Click here for details.
