This conference is intended to be a practical workshop for PIP/PSP development and implementation. It will provide attendees from academia, industry, and regulatory authorities, a forum for discussing real-life examples and real-world lessons on a variety of topics.
Topics will include:
- Successful engagement and partnering with COG and non-COG cooperative groups in/outside of the US
- Lessons learned from in writing and negotiating successful PIPs and PSPs
- Planning for pediatric formulation development
- How best to consider the need for and timing of juvenile and developmental toxicity studies
**Session topics will be added in the coming weeks.