Skip to content

11 July 2018

1) CTF

Steering Committee – A call will be organised next week with committee members. Ian has already highlighted by email that he would like to discuss ‘what if’ scenarios with a smaller group before bringing up the issues with the Committee itself.
Aurelie resigned and proposed Guillaume has her successor. Is there any formal procedure to be followed or can we simply accept the decision by the French collective and include Guillaume in the committee?

WG 1 – No news since Rahul is still on holidays.

WG3 + 4 – 14 WG members have signed up for the face-to-face event in October. Gonzalo wanted me to bring up the CTF information package. Do you have comments on the documents (information package | NCA package)? Moreover, can we share it with WG 3+4 members? Shall we gather comments by email or do you want us to organise a call before August?

Stakeholder mapping template – Do you have comments on the document shared by Gonzalo?

Endorsements – The following members have endorsed the CTF project: Italy, Spain, France, Malta, Latvia, Romania, Estonia, Slovenia, Austria, Croatia, Hungary.

2) Compounding

Brief report from the Roundtable discussion on pharmaceutical compounding (10 July). Data collection on the existing practices + guidelines/SOPs on national level potentially to be considered for a discussion at the September Board meeting.

3)  Hazardous Drugs

Brief report on the meeting with MEP Rodin’s assistant (11 July).

4) Consultations – state of play

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
21/08/18 Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry Is this something we should participate in?
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
31/08/18 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 Petr looked at it; SK will prepare brief comments before her holidays.
10/09/18 Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products shared with Frank Jørgensen
13/09/18 Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections Shall I share this with the Board leads? There are also 2 Dutch ‘EMA experts’ that indicated medical device expertise. In case there is a link to AMR I have 2 more ‘EMA experts’.
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

Given the existence of a number of EMA experts, are we considering the commenting on bioequivalence guideline consultations or are we continuing to not participate in these?

5) HTA

Brief update on the HTA meeting organised by the Commission (9 July). From the comments by the Commission representatives it seemed that they are only taking into account written feedback (i.e. Statements by associations) that they have received so far.

6) FMD

Meetings with the Commission – Brief update on the meetings with the European Commission. Very little interested from the Commission in assisting us with our problems has emerged from these meetings.

FMD calls with members – calls started on 10 July. There will be 4 in total. The last one is going to be held on 17 July. The aim of the calls is to update each other on the progress. Countries that cannot participate will be asked for written feedback.

7) AMR

Austrian presidency event – I checked the Austrian conference in November. The programme was already set in advance and cannot be altered. It is going to be in German and seems to be very much physician focused.

EU JAMRAI – The initiative is still working on the MoU. It will be shared shortly (not sure when they have been saying this for month). We however already got invited to the first Stakeholder meeting on 9th November in Vienna. I forwarded the invitation to Steffen and Kees.

8) September Board meeting

Policy part – Are there any policy topics that you would like to discuss in addition to the ‘usual suspects’ (i.e. FMD; AMR; shortages; eHealth; barcoding; medical devices; HTA; biosimilars; etc.)? Do you need any additional information on ‘up and coming policy issues’ for your strategic meeting and the review of topic areas/board leads?

April Board meeting action items – The following points were deferred until the GA, endorsement policy + annual report ideas. Joan, how do you want to proceed with these. Shall I prepare a first draft by the end of July for you to comment on in August while I am on holidays?
What about the EJHP piece on Brexit/shortages and FMD. Joan are you still planning to draft an article on this? Pascal Garel (HOPE) has agreed to write an editorial for the November issue.

9) Miscellaneous

MNI – initiative on home parenteral nutrition – role of hospital pharmacists
Please find HERE the endorsement check following our checklist of MNI.

MOIC
I completely forgot about the MoU which was signed by Petr in June. I will email it to MOIC asap.

PGEU
PGEU is carrying out a perception audit (see HERE). Do we want to participate?

EPDA’s Multidisciplinary expert review panel
EPDA approached me about their expert review panel. They were previously put in touch by Richard with Kate Leonardo (North Bristol NHS Trust). However she seems to have left her former position and they are now looking for her contact details or other experts.

Politico – Shortages article
Politico reached out to me to discuss shortages and parallel trade for an article they are working on. What do you think about this? Nenad asked for your input.

  

Next policy call? Week of 23/7 or week of 30/7?

 

×

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.