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. 

Time Topic Speaker
14:00 Welcome and setting the scene Patient & regulatory expert and toastmaster : Merete Schmiegelow  
14:15 14:50


15:25
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
Q/As
TBC
TBC
15:30 Coffee/Tea break
15:50 16:10 16:30 Industry cases from involvement of patients experience data in clinical development   E. Lilly CSO
Q/As

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 Chair:
DKMA, TBC
16:55 Wrap up Chair of panel discussion
17:00 Conference end  

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.