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26 November 2018

1) CTF

Steering Committee
The Steering Committee will be meeting via conference call in December. A Belgian member has been appointed.

WG 1
WG 1 had its meeting on 27/10. The minutes went out this week and are available on SharePoint. At the moment, GML is checking the action items with Rahul. Once confirmation is received from Rahul, we will start working on the action items.

WG 2
The individual members of WG2 are currently reviewing the different papers that Roberto had collected.

WG3
GML will start next week with the follow-up from the meeting in October

Commission
SK forwarded a request from DE to Sophie. DE is interested in an official response from the Commission in relation to the questions that we raised on behalf of them during our last meeting in May. In addition, SK asked Sophie about the type of evidence needed from WG2.

2) Policy updates

AMR
SA and SK attended the EAAD event of ECDC. SA is involved in ECDC’s survey activity. ESNO reached out to PGEU, EPF and us to see if are interested in discussing further about AMR. A meeting was proposed by Ber. A data has not been set yet.

Shortages
Good feedback was provided in relation to our survey. A number of associations are inquiring about follow-up activities. In addition, Amgen is interested in funding a policy study. The Board leads are aware and we will start discussions this week.
Dissemination of the survey is ongoing. A message will be sent next week to Presidents and Delegates with a request for further distribution on national level. Country reports for the EU5 are online. Country reports for Ireland and Greece are being finalised. One for Romania is going to be drafted.

EMA
The EMA reached out to us in relation to the participation in scientific procedure (more information HERE). Initial feedback is needed by 29 November.

FMD
AS and SK will be attending the Stakeholder meeting and the extraordinary Board meeting on Tuesday. Main discussion items are alert handling, the community pharmacy portals and bulk verification. In addition, we will be launching a data gathering activity to obtain information on the status of FMD implementation in our member countries.

Changing roles of HPs
The Board leads have kicked off their activity. In early December we will be discussing the first draft of the business case.

COPHELA
Prof Atkinson finally got back to us. He outlined that the involvement of EAHP rather depends upon our interest. We could opt for minimal involvement which would mean advertising the COPHELA meetings and publications on our website. Or we could be involved in production actions and run surveys in Latin America. SEFH is involved in COPHELA.

Grants/funding opportunities
VD due to her previous work has experience in the drafting of grant proposals. She shared some interesting ideas in relation to different funding opportunities. She prepared a summary on the activities of the Open Society Foundation (see HERE).

3) Consultations – state of play

The EMA also released draft guidelines on excipients in the label and package leaflet of medicinal products for human use (see HERE). In the past we decided not to participate in such specific consultation requests. However, given that the consultation concerns patient leaflets should we provide input?

18/12/18 Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management – Step 2b  We won’t comment.
17/02/19 Public consultation a draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders  
14/03/19 eSource Direct Data Capture (DDC) qualification opinion  
31/03/19 Draft concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury  
15/05/19 Guideline on the quality of water for pharmaceutical use  
30/06/19 Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease  
30/06/19 EMA discussion paper:
Use of patient disease registries for regulatory purposes – methodological and operational considerations
 
31/07/19 Public consultation a draft guideline onquality, non-clinical and clinical aspects of medicinal products containing genetically modified cells  
31/07/19 Public consultation – Draft questions and answers on Data Monitoring Committees issues  
31/08/19 Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)  
31/10/19 CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products  

4) Congress

Presidents guests
Positive replies have so far been received from all pharmacy organisations (ASHP, PGEU, ESOP, ESCP, EAFP). EIPG also expressed interested as well as EDQM, UEMS, ENDA and ECCO (not yet confirmed).

CTF meeting @ Congress
We received positive responses from 10 countries (BE, DE, FR, EL, IE, MT, NL, SK, ES and RO). AT and SI have expressed interest. We are still missing official and final confirmations, but realistically we are looking at welcoming around 10 to 12 countries. WG3 members (provided that their country is joining) will be invited. We have a meeting room at the Congress centre that is big enough to fit the entire group in u-shape.

5) Miscellaneous

EJHP – position paper publication
IVG met with Lindsey on Friday. The position papers need to be submitted by invitation. Lindsey will draft a schedule for SK. SK will take care of the submission. Regarding the old papers, she highlighted that they could have a negative impact since they might not be cited as widely as new articles. Given the importance of some of the topics, we should discuss the possibility of an update for some of the papers. Below please find all position papers:

Statement on Hospital Pharmacy Specialisation (2011)
Statement on Patient Safety (2011)
EAHP Statement on Medicines Shortages (2012)
EAHP Statement on the need for barcoding of the single dose administered in hospitals (2012)
EAHP Statement on clinical trials (2012)
EAHP Statement on public spending austerity and its impact upon access to medicines and patient safety (2013)
EAHP Statement on medical device regulation (2013)
EAHP Statement on sustainable and equitable access to medicines (2014)
EAHP Policy Statement on an ageing society (2016)
EAHP Position Paper on eHealth and mHealth (2017)
EAHP Position Paper on Biosimilar Medicines (2018)
EAHP Position Paper on Procurement (2018)
EAHP Position Paper on Antimicrobial Resistance (2018)

An update would be for the statements on the specialisation, patient safety and shortages.

Next policy call? In December after you are back from ASHP?

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