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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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

14 June 2016

Action

Speaker

For information

Committee

4. Committees feedback 12:00

4.1 Feedback from scientific committee

representatives

members 5. EUPATI 12:30

5.1 EUPATI guidance documents

For information

D. Haerry

6. AOB 13:00

Lunch

Agenda - EMA Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting EMA/274681/2016

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