Part C, D and E: Waivers, Study Plans, Deferrals - Where things can go wrong, potential problems and how to avoid them - Jan Gross, Merck Serono, Germany

Session 3

Part C, D and E: Waivers, Study Plans, Deferrals - Where things can go wrong, potential problems and how to avoid them

Jan Gross, Merck Serono, Germany

Presentation followed by questions and answer session

• General considerations for preparing Part C-E, e.g. how detailed should it be?
• Part C - Waivers: Examples of accepted grounds and rejections, e.g. for younger age groups; assessing feasibility of studies etc
• Part D - PIP: Strategy proposed for the paediatric development:
  • Quality, non-clinical and clinical aspects
  • Measures for development within paediatric populations
• Part E - Deferral: Criteria for timing of studies in paediatrics in relation to development for adults
• PIP/Waiver procedure: How can sponsors best use the opportunities for communication to effectively facilitate the review and approval process?