2018 ASCPT/IQ Symposium & Workshop
2018 ASCPT and IQ Half-day Symposium and Mock-team Workshop: Pediatric Drug Development: Challenges and Opportunities in Extrapolation
The American Society for Clinical Pharmacology and Therapeutics (ASCPT) and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) are collaborating to present a symposium addressing pediatric extrapolation in two focus areas:
Pediatric oncology therapeutic development;
Mock-team workshop with inter-disciplinary discussion on pediatric extrapolation issues, challenges and strategies using type 2 diabetes as a case study.
The symposium and workshop will be held on March 21st, 2018 in Orlando, Florida, as part of the ASCPT Annual Meeting pre-conference workshops. Speakers and discussion moderators will include leading experts from FDA, EMA, academia, and industry.
This half-day forum will provide participants with practical information, considerations, and strategies, as well as ample time for open discussion through a Q&A session. Specific discussion topics will include:
Pediatric oncology:Master platforms and protocols; trial design and molecular prioritization criteria;
Pediatric type 2 diabetes: The role of a multi-stakeholder decision-making body including regulatory agencies, academia, and industry; logistical and operational considerations; regional pediatric regulations; globalization challenges; evidence generation; and the planning process for pediatric development.