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28 August 2019

1) CTF

Steering Committee
The draft agenda (see HERE) has been shared with Ian for comments. GML also inquired about Ian’s vision for the future activities of the Steering Committee.

CTF WG1
WG1 is currently working on sharing the finalised mappings with the Boards of the national associations. A call will be organised in mid-September to discuss the progress.

CTF WG2
Roberto and Nenad agreed to submitting the report as an abstract to Congress. SK and GML are assisting with the preparations.

CTF WG3
WG3 is currently following-up with national member associations. A call should be organised before the Steering Committee meeting.

2) Policy updates

Accreditation/ECPhA

  • Collaboration with UEMS
    SK is following up with UEMS this week. UEMS has been asked in late July to prepare a draft MoU. The MoU was shared today (see HERE). It is very basic.
  • ECPhA meeting with pharmacy organisations
    On 18th October a meeting with pharmacy organisations should be prepared. The invitation can however only be prepared after SK and IVG have worked on the basic documents outlining the goals/workings of ECPhA. Documents will be prepared by 11th September. On 12th September feasibility to organise a meeting with pharmacy organisation will be re-evaluated.

Shortages

  • Investigation letter – request for ENVI committee
    Signatories are being collected. 
  • COM meeting 23rd September
    Official invitation has not been shared yet. András could attend. What kind of information do we want to share, keeping in mind that they have seen our survey report?

eHealth

  • COM has opened the call for the next eHealth stakeholder group. The call will be shared with the Board. RM due to Brexit cannot be nominated.

Procurement

  • Call between Medicines for Europe and EAHP procurement leads is being organised in early September.

3) Board meeting preparations

President’s guests @ Congress
The President’s guest list (see HERE) needs to be finalised. In particular, the category 2 guests need to be picked.

4) Consultations – state of play

31/08/19 Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) Clinical trial board leads
31/08/19 EMA Consultation – Guideline on the quality requirements for drug-device combinations AS and AB contacted + reminder sent.
01/09/19 EMA – public consultation the draft ICH guideline M10 on bioanalytical method validation – step 2b We won’t comment. 
08/09/19 COM Consultation: Horizon Europe – Orientation towards strategic planning Draft almost ready.
08/09/19 IAEG-SDGs 2020 Comprehensive Review Policy team is working on 1st draft.
20/09/19 EMA consultation – Draft qualification opinion of Multiple sclerosis clinical outcome assessment (MSCOA) We won’t comment.  
29/09/19 EMA Consultation: ICH guideline E19 on optimisation of safety data collection Check relevance with JP. 
30/09/19 EMA Consultation – ICH guideline E8 (R1) on general considerations for clinical studies – Step b Clinical trial board leads
30/09/19 EMA public consultation on a draft reflection paper on the qualification of non-genotoxic impurities We won’t comment. 
09/10/19 EMA consultation – Draft qualification opinion of clinically interpretable treatment effect measures based on recurrent event endpoints that allow for efficient statistical analyses  Check relevance with PP.
31/10/19 CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products We won’t comment.

4) Miscellaneous

ESA
Feedback from PH on signing the endorsement agreement needed (see HERE). In addition, a short biography (80 words) from PH has been requested.

EFA
Feedback from PH on the support request for #ShowLeadership campaign needed (see email HERE).

ENDA
ENDA provided feedback regarding the medication safety procedure (see email + feedback document).

ECCO
SK is meeting with ECCO (task from April Board meeting) to obtain further information on the membership opportunities

Euro Pharmat invitation
NM will attend.

PPMI tender application
In light of ECCO’s email (see HERE) do we want to reconsider our view on the PPMI tender application and engage?

ESCP
No feedback on the MoU was received so far. SK will follow-up again.

 

Next policy call – Thursday 12 September?

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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.