21 June 2022

1) CTF

The CTF Steering Committee is meeting on 20th of June. GML will give an update during the policy call.

2) Policy updates

FIP

• Council meeting at FIP Congress: As discussed GML will join the Council Meeting. NM will also be in Sevilla as well as Roberto Frontini.
• FIP-European regional engagement meeting (21/6): AS & SK will report back.
• FIP Report on Sports Pharmacy: Clinical and/or operational case studies: FIP is looking for experts. LB has no expertise. AS do you have any and do you want to even engage?

IMVO study on added value of barcoding infrastructure (email from JP)

• JP reached out looking for “a summary of point to make on this that were identified before now – anti-competitive if data not shared / pressure on prescribers etc.” She also shared the following IMVO presentation (see HERE). @ AS – any thoughts on this?

EAHP-EANM joint statement

• @ AS – which key points should be included?

EPHA Membership – Approval of EPHA’s 2021 accounts

• Belgian law requires that the annual accounts of a Belgian AISBL, which is EPHA’s legal structure, be presented to and approved by the members within six months of the end of the financial year, which ended on 31 December 2021.
• The Auditor has given qualified approval to the EPHA accounts for 2021. She has examined the overall financial situation very carefully and gave a positive opinion of the financial situation of the association. The auditor is therefore able to recommend that the 2021 accounts be approved by the Membership.
• The 2021 accounts finished the year with a surplus of 48.656,69 €.
• Can EAHP as member of EPHA approve the accounts?

Expert Panel on effective ways of investing in health (EXPH) | Interview

• @ AS, PH & DKP what are your thoughts on an interview with ICF for the EXPH study?

Request AI in hospital pharmacy

• @ AS & DKP we received a request concerning AI in hospital pharmacy: “I am a Post-doc at Halmstad University, and I am involved in the interdisciplinary innovation management research project “information-driven healthcare.” I will be grateful for help with indicating the examples of data-driven technology (like AI) applications in hospitals. Greetings, Anna Żukowicka-Surma”

Board Summer holidays

• The entire Board was asked to share their holidays, so that like last year an overview can be prepared. The overview can be found HERE.

Open issues – linked to emails shared in the past weeks

• SK will go with AS through all open issues.

      András: 
                   EHP – wellbeing feedback | please share this with SK once you have reviewed the document.  
                   EHMA 3rd Alliance Meeting: Digitalisation of Medication Managemen (4th of July at 16.00) 

4) Consultations – state of play

Due date	Type of consultation	Action
27/06/2022	COM: 2023 Stakeholders’ Targeted Consultation on EU4Health priorities, strategic orientations and needs	SK will share the draft response with AS, PH and DKP. Feedback should be shared by 24 June.
30/06/2022	EHDS: COM proposal feedback period	Digital health Board leads will receive the draft response in early July.
05/07/2022	EUnetHTA21: EUDAMED data reporting template/guidance for EUDAMED-based TISP (Topic Identification Selection and Prioritisation) for MD	LB and DM are reviewing.
31/07/2022	EMA consultation: ICH guideline Q2(R2) on validation of analytical procedures	Shared with EMA leads. Advice from PP – no need to engage.
31/07/2022	EMA consultation: ICH guideline Q14 on analytical procedure development	Shared with EMA leads. Advice from PP – no need to engage.
06/08/2022	EMA consultation:ICH guideline E11A on pediatric extrapolation	PP and DM proposed to involve the paediatric leads. Paediatric leads (PH, AL, LB) shared their feedback. SK is reviewing the input. .
31/08/2022	EMA consultation: Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes	Shared with EMA leads. Advice from PP – no need to engage.
08/09/2022	EMA consultation: Guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS)	PP recommends to engage and already shared feedback.

Next policy call – Wednesday, 6th of July?