14 June 2016 EMA/274681/2016 Stakeholders and Communication Division
Agenda - EMA Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting 14 June 2016, 09:00hrs to 13:00hrs – meeting room 3E
Co-Chairs: Isabelle Moulon (EMA) and David Haerry (PCWP) 14 June 2016
Action
08:45
Registration and reimbursement arrangements
08:55
Welcome and introduction / Health and safety information
Speaker
I. Moulon (EMA)
Disclosure of interests / Adoption of the agenda 1. PCWP activities 09:00
1.1 New PCWP mandate
For information
N. Bere (EMA)
09:10
1.2 PCWP members ‘Tour de table’
For information
All members
09:50
1.3 PCWP anniversary
For information
M. Mavris (EMA)
2. EMA initiatives to support and accelerate early access 10:00
11:15
2.1 Update on PRIME initiative
For information
J. Llinares Garcia (EMA)
2.2 Update on adaptive pathways
For information
F. Cerreta (EMA)
For information
A-S. Henry-Eude (EMA)
Coffee Break
3. Access to documents 11:30
3.1 Proactive publication of clinical study reports; redaction of commercially
and discussion
confidential information
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Jun 14, 2016 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom ... EMA initiatives to support and accelerate early access. 10:00 2.1 ...
Nov 3, 2016 - Scope: 'Optimising the development of ATMPs to meet patient needs' ... the CAT would like to discuss with company representatives in person.
Oct 23, 2017 - under Article 107i of Directive 2001/83/EC, based on pharmacovigilance data. Action: For adoption of ..... manufacturing process; and 3) removal of the following missing information: special patient groups. Action: For .... analysis of
Jul 31, 2017 - Human Medicines Research and Development Support Division. Agenda ... use of such prior knowledge in regulatory application dossiers, to support manufacturing and control strategies ... of accelerated access schemes.
Oct 26, 2016 - (as Web sites for social networking and microblogging) through which ... 09:10. Opening remarks. D. Haerry (PCWP)/. G. Calvo (HCPWP). 1.
Nov 27, 2017 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be
