Pre-Meeting Readings and Information

In addition to presentations at the “Pediatric Formulation Development: Challenges of Today and Strategies for Tomorrow” meeting, there will be breakout sessions and panel discussions.

The meeting organizers want to provide a platform for sharing of ideas between academics, the pharmaceutical industry, and regulators; as a result, breakout sessions where ideas can be freely exchanged will be held after podium presentations.

To facilitate discussions at the breakout sessions, we have prepared some questions and readings that we would like you to review and consider before coming to the meeting. We also encourage participants to bring their own ideas to the breakout sessions. The questions are posted below, and can be downloaded by clicking on the links for each breakout session.

Formulation:

• Formulation Breakout 1: Excipients
• Formulation Breakout 2: Acceptability
• Formulation Breakout 3: Devices

Analytical:

• Analytical Breakout 1: Mini-tablets Specification
• Analytical Breakout 2: Dosing Vehicles

Clinical:

• Clinical Breakout Session 1, 2, and 3

Regulatory and Industry Feedback:

• Regulatory and Industry Breakout 1: Regulatory Lessons Learned
• Regulatory and Industry Breakout 2: Future Landscape