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EAHP Policy Call 10th October 2016

1) CTF 

WG1

Final finessing of consultation draft underway. AB gave a further deadline of 10th October for final remarks from WG1 members.

WG2

Lorna, Nenad and Cornelia leading in completion of paper.

WG3

To discuss dynamics of consultation (timings, form etc).

Draft recruitment strategy here.

Recent JP comments on recruitment here.

Report back from SEFH Congress (4th-7th October) 

Look ahead to Italy Congress (2nd-4th December).

(Also Czech Congress in November)

2) FMD

Recent Written response of Commission here.

To also discuss proposed activity with members (arising from September Board Meeting discussions). 

3) Shortages

To discuss Bratislava Health Ministers’ meeting, and follow up (i.e. letters to Commissioner and Slovak Health Minister).

To discuss Draft European Parliament Access Report, and proposed amendments.

To discuss recent COST Action and promotion activities.

To discuss research needs.

 

4) Consultations

  • Commission consultation on the concept of similar medicinal product in the context of orphan legislation.
 
Consultation hereDeadline 4th November. 2nd draft of response here.
 
Marc Dooms remarks here. JP remarks here. Jamie Wilkinson remarks here.
 
  • 3 EMA Pharmacovigilance consultations
Consultations here, here and here. Deadline 14th October. GHP responses here, here and here.
 
Any major points to raise?
 
  • European Commission consultation on clinical trials in developing countries
Consultation here. Deadline 15th October. Any particular points to raise?
 
  • European Commission consultation on European Pillar on Social Rights
Consultation here. Deadline 31 December. Some NGOs becoming energised about conveying the need for an EU more involved in health.
 

5) EMA Matters

8th December Workshop on Adaptive Pathways.

6) Misc

To discuss:

– Off Label Use

– Jeffrey Atkinson request (and Phar-QA)

7) Future events

To note:

Thursday 13th October, Health First Europe Patient Safety event. Invitation here. To see referenced ‘Patient Safety Policy Indicators’ here. 

Thursday 13th-14th October, Phar-QA meeting

Tuesday 25th October – FIPRA Biologics Meeting (FJ to attend)

Tuesday 15th November – PGEU event in the European Parliament. More information here.

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