Skip to content

18 June 2018

1) CTF

Steering Committee
Gonzalo updated Ian. He told him that the strategic proposal was approved and about the meeting with the Commission. We are currently waiting to see if Ian wants to do a conference call with the Steering Committee members before the summer. In case we do, we will discuss the COM meeting + the strategic proposal adoption during the call. In case he does not want to do a call, we will inform members by email.

WG1
Gonzalo emailed Rahul to double check if the face to face meeting on 27 October is doable for him. Once Rahul confirms, we will send out invitations.

WG3 +4
The face to face meeting will take place on 13 October. This date works for you, right?
We will send out invitations shortly to ensure that WG members can book their flights early.

Other CTF related issues:

  • Mapping template – Gonzalo is currently checking the content with France
  • Information package – Marta and Gonzalo are working on it. They plan to have a draft ready by early next week. Afterwards it will be shared with WG3 for comments. Would that be ok? A call can be organised if needed.
  • Letter for EPSA – Gonzalo will change it since Petr is now president
  • CTF FAQs – the replies to the questions by DE will be transformed it FAQs and uploaded on the website
  • Gonzalo will also discuss the evidence collection with Tony
  • Emails to presidents and delegates – we will send 2 emails to presidents + delegates
          One will go to all about the evidence
          One will go to those with a specialisation that have not yet registered it

2) Shortages survey

We received 1898 responses (875 completed | 1023 partially completed).

3)  AT

On 1 July Austria will take over the presidency. Joan you asked me to add this to the agenda for today.

The Austrian priorities focus on migration, security, connection, subsidiarity, environmental sustainability. Health is not mentioned explicitly.

There are however a few events organised in relation to the activities of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO). Attached please find these events. Two EPSCO conference will focus on food, while the third covers occupational cancer. I am however not sure if the latter is linked with hazardous drugs since no additional information is available yet.

Moreover, the European Antibiotic Awareness Day Symposium could be interesting for us. Depending on whether it is open to the public, I think one of the AMR Board leads should attend.

4) Consultations – state of play

Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice – we don’t participate, right?

31/07/18 EMA – questions and answers document on Bovine Spongiform Encephalopathies (BSE) and vaccines – Revision 1 Joan will look at it; reminder to be sent after GA
31/07/18 EMA – a draft guideline on quality aspects included in the product information for vaccines for human use Joan will look at it; reminder to be sent after GA
31/07/18 EMA – reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population request sent to Branislava Miljkovic
30/08/18 EMA – draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements – First version Joan suggested to contact an Irish HP
10/09/18 Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products shared with Frank Jørgensen
30/10/18 EMA – draft guideline on clinical evaluation of vaccines – Revision 1 Joan will look at it in September
18/12/18 Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management – Step 2b  on hold until summer 2018

5) HTA

During the call the functioning of the HTA health providers group will be explained to Petr. A ‘briefing document’ will follow in the course of this week with all information on HTA.

6) FMD

Meetings with the Commission
Two meetings will be organised in the next weeks. The first will take place on 26 June. In addition, to Commission representatives also Member State representative will join. Rob will attend. The second meeting will take place on 4 July. Only Commission representatives including Director Andrzej Rys will join. András will join.

FMD calls with members
As highlighted during the GA, we will organise calls with members on FMD in July. I am currently finalising the dates with Rob. András and Despoina already indicated their availability during their visit to Brussels on Friday. We will offer 3 to 4 dates and limit the attendance to 10 countries per call.

7) Miscellaneous

EMA PRAC nomination
The PRAC applications were submitted. I informed both Carlo and Roberto that the procedure is very lengthy (results will be expected at the earliest in spring 2019) and that additional requests for the submission of data

UN Sustainability Goals
The Commission has launched the first ever European Sustainability Award to recognize the efforts and creativity of European businesses, organisations and individuals who work towards reaching the UN Sustainable Development Goals. This year, the theme of the award is “Empowering people and ensuring inclusiveness and equality”.
Shall we share this with members?

MNI – initiative on home parenteral nutrition – role of hospital pharmacists
They emailed today about an initiative on home parenteral nutrition (see HERE). Are we generally interested in this subject? If yes, I can check MNI and provide you with more information. 

 

Next policy call?

 

×

EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.