How to manage a successful health authority interaction 2015

Topics

• Guidance for Industry on Critical Path Innovation Meetings
• Draft FDA Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
• Best Practice guidance for Pilot EMA HTA Parallel Scientific Advice procedures and HTA Network meetings
• EU Adaptive Licensing Pilot Project

Who should Attend

• Medical Affairs Professionals
• Clinical Research Professionals
• Drug Safety / Pharmacovigilance Professionals
• Statisticians
• Chemical-pharmaceutical disciplines
• Non-clinical disciplines
• Project Managers