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Policy Call – 20th October

1) CTF

WG 4
We need to discuss the kind of documents that we should have ready for the meeting of WG4. I can ask Crt to put together an overview document with different types of accreditation that exist to provide some food for thought to the group. In addition, a short presentation on CTF in general would be beneficial since not all group members have been involved in the CTF process.

Labour mobility
Did Mairead McGuiness get back to you?

Did you both have a chance to review the labour mobility survey report?

2) President’s guest list Gothenburg

I prepared an overview of the guest that were invited to Cannes (available HERE). At the board meeting you discussed that the focus should be put on doctors and patients

3) FMD

EMVO
Rob and I will be attending the next EMVO Stakeholder meeting on 25th October during which the hospital platform should be discussed. The following information was shared with EMVO (presentation). Emphasis will be put on our asking the EMVO secretariat to reach out to NMVOs and facilitate the hospital stakeholder involvement.

Follow up with members
I will approach each national member president (in case of FR and DE I will send the email to their new “inbox” that should be used for all EAHP matters) to inquire about the status of FMD implementation. The following document outlines the information that will be collected.

4) Consultations – state of play

12/10 Commission – Consultation on the transformation of health and care in the Digital Single Market submitted
13/10 EMA – Guideline on good pharmacovigilance practices (GVP) – Product- or population-specific considerations IV: paediatric population submitted
20/10 HMA/EMA Joint Task Force on big data – Survey for Pharmaceutical Industry awaiting reply from board leads
31/10 EMA – public consultation product-specific bioequivalence guidance submitted
31/10 EMA – concept paper: revision of the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells – superseeding document short reply – concept paper ok; looking forward to consultation (to be submitted next week)
31/10 EMA – concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals short reply – concept paper ok; looking forward to consultation (to be submitted next week)
15/11 EMA – concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle short reply – concept paper ok; looking forward to consultation (to be submitted next week)
14/01/18 Reflection paper on the use of extrapolation in the development of medicines for paediatrics request sent to Inese and Anthony
31/01/18 EMA – Reflection paper on the pharmaceutical development of medicines for use in the older population send to Kees/SC

5) Miscellaneous

Video pledge/ EAHP statement for EAAD
The video pledge should be very short (30 seconds to 1 minute). The statement should outline how EAHP keeps antibiotics working. We could mention antimicrobial stewardship teams in our member countries, our position paper and the ACASEM.

EMA work plan 2018/2019
The board members did not have many comments. Nenad suggested to add Health Technology Assessment in the “Early access to medicines” and “Benefit-risk assessment” fields.

Background information on organisations
During the board meeting you asked me to look further into the European Society for Patient Adherence, Compliance and Persistence (ESPACOMP) that was mentioned by one of our industry advisory group members.

ESPACOMP is a non-profit established to promote the science concerned with the quantitative assessment of what patients do with medicines they have been prescribed. They are not registered in the EU’s transparency register. Moreover, it is very difficult to figure out who sits behind the association. The following persons are in their Executive Committee, Sabina de Geest (KU Leuven), Juliet Foster, Dyfrig Hughes (Bangor University), Marie-Paule Schneider, Bernard Vrijens (AARDEX group), Leah Zullig, Liset van Dijk, Alpana Mair, Sabina De Geest, Monique Elseviers, Eric Van Ganse , Robert Vander Stichele and Bernand Vrijens.

Their main activity is their annual congress which has on average 150 participants. Their other two main activities are ABC – Ascertaining Barriers for Compliance (a cooperation of łodz Medical University, KU Leuven, AARDEX group and Keele University) and the Healthcare Compliance Packaging Council (aims at educating the healthcare sector about packaging that improves the life of patients). The latter project is funded by industry (Abott, ACG Worldwide, Amcor, Astrazeneca, Bilcare, Constantia, Roche, Honeywell, IMASafe, Klöckner Pentplast, MTC Pharma Center, Novartis, Palladio, Sanofi, Storaenso, Tjoapack, Westrock).

EXPH – Draft Opinion on Benchmarking access to healthcare in the EU
We need to discuss if we provide comments to the draft. The deadline is 26th October.

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EAHP Forum

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