Are We Prepared for the Regulations on Patient-Focused/Patient-Centric Drug Development?

17:00 - 17:45

  • With the recent first FDA draft Guideline on Patient-Focused Drug Development (PFDD) and three additional guidelines to follow as well as the finalization of the EMA Reflection on pharmaceutical development of medicines for use in the older population”, patient centric drug product development is becoming mandatory for the pharmaceutical industry
  • What does it mean to the pharmaceutical industry, how do we build a framework of patient centric/focused drug product development
  • Take an opportunistic view how this can help to create a competitive advantage by adding real value to patients and payers
  • Debate on how to best take advantage of the emerging regulation and influence its implement

Sven Stegemann, Director, Pharmaceutical Business Development, Lonza

Leonie Wagner-Hattler, Formulation Scientist, F. Hoffmann-La Roche

Louise Place, Head Of Regulatory Affairs and Senior Quality Assurance Consultant, Cambridge Design Partnership