why, what, how and when to collect patient experience data in clinical trials as part of regulatory decision
Organized by Clinical Trial Experience Data Academy (CTED Academy) in collaboration with Biopeople, Copenhagen Centre for Regulatory Science (CORS), European Patient Forum (EPF), European Patients’ Academy (EUPATI) Denmark
Date: 4th November 2019 from 14:00 to 17:00
Venue: Crown Plaza Hotel, Copenhagen Towers, Ørestads Blvd. 114 – 118, 2300 Copenhagen S, Denmark, 5 min. walking distance from the ISPOR conference that is taking place 2-6th of November at the Bella Center, Center Blvd. 2300 Copenhagen.
Registration: Cost for others than patients/patient organisations and authorities : 100 Euro
Objectives: Patients are increasingly acknowledged as experts in their own disease and what they observe and experience when taking their medication. The objective of the programme is to present . What are the EMA and FDA as well as industry current and future approaches to encompass meaningful patient observations and experiences captured in clinical trials and used as part of regulatory processes and public scientific approval documents as e.g. Product Information, the European Public Assessment Report (EPAR) and US Summary for Basis of Approval (SBA). Perspectives from a patient advocate, regulators and industry will be presented and debated.
|14:00||Welcome and setting the scene||Patient & regulatory expert and toastmaster : Merete Schmiegelow|
|14:15 14:50 |
|Regulators – status and plans for patient engagement in regulatory processes and, patient outcomes as part of decision-making and public documentation including Product Information and learnings: EMA, EU FDA, USA |
|15:50 16:10 16:30||
Industry cases from involvement of patients
experience data in clinical development
Patient outcome expert – TBC Patient Experience Data expert Jens H. Kongsø
|16:35||Panel discussion Each speaker including chairs prepare in advance 1-3 key challenges within their areasAudience Q/As||
|16:55||Wrap up||Chair of panel discussion|
Disclosure of any conflict of interest:
The purpose of the symposium is to inform and debate the current and future scientific, regulatory focus and use of patient experience data from clinical trials in regulatory assessments of new drugs.
The budget for speaker travel and venue costs will be covered by registration fees incomes and voluntary, human contributions.
Patients, patient organisations and regulatory authorities participants will obtain free entrance. Others have to pay 100 EURO per seat.