10 March 2022

1) CTF

Action plan

• Action plan was shared with Ian and Rahul. GML plans to email it to all Steering Committee and WG members for comments before congress.

Outreach

• The outreach to WGs/steering committee members is almost completed. Only a few are missing.

Request from Vesna

• @ AS – could you please provide feedback on the request from Vesna about a presentation on 5th of April to GML.

2) Policy updates

FIP exchanges & next meetings

• FIP Extraordinary Council Meeting – Taking place on 7th of April from 13.00 to 15.00. AB will attend.

SIG HMP – final documents

• @ AS – you and PP are the only ones that have not commented yet on the documents.
• @ AS/AB & PH – during the last policy call you had highlighted that the guidance document should only be released after the GA. You wanted to flag this to the other BMs in the conversation about the final documents. Could one of you still do this?

Alliance for Digitisation of Medication Management

• Meeting with George on 17th of March at 5pm. Should SK join?

ENSH | Draft White Paper patient safety

• @ AS – I am still missing your feedback. CP is so far the only one that shared input. The deadline for handing in our feedback was last week. HFE agreed that we can send it still this week.

EPSA Chat with Professionals

• SK is waiting to hear back from EPSA. If only 1 person can join, AS will join as per his request .

Open issues – linked to emails shared in the past week(s)

SK will go with AS through all open issues.

• AS | EFCCA article outline (SK will integrate the points from AS) & EFCCA academy
  VE social media campaign on “Realising the full value of vaccination” 

3) Board meeting follow-up & Congress

President’s guest invitations

• The meeting with EMA will be virtual.
• ECPC cancelled participation. As previously announced, so have EAFP and the other two international organisations (Asia/South America)
• ESCMID cancelled, but would like to meet with us virtually.
• Still waiting to hear back from PGEU (2 AT representatives)
• Confirmed meetings: Egypt (international organisations), EDQM, EANM, ASHP (only with Tom, Paul will not be coming to Vienna), ESCP, EPSA, ESOP and EFCCA.
• @ AS – do you have any comments on the briefing documents received by email? The one for EDQM is still being created since they only confirmed their attendance on 9/3. The one for PGEU will be created once they confirm their attendance.

Members’ Meeting

• @ AS & PH – Do you have any comments on the slide you received by email?

Meeting with past Board members

• SK is working on putting the slides together.

4) Consultations – state of play

Due date	Type of consultation	Action
14/03/2022	Survey on EMA targeted communications	Waiting for feedback on draft response from PP & DM.
15/03/2022	EMA – consultation: ICH harmonised guideline on Quality Risk Management Q9 (R1)	Feedback was submitted.
24/03/2022	COM – Antimicrobial resistance: recommendation for greater action	SK working on response. Content already discussed with AMR leads.
31/03/2022	EDQM – European Paediatric Formulary consultation (Simple syrup (preservative-free) and Phosphate 60 mg/mL Oral solution)	Feedback was submitted.
04/04/2022	HMA | CMDh Multi-annual Workplan to 2025 – For public consultation	Leads agree with engagement. SK is working on draft response
05/04/2022	EUNetHTA21 – D5.3 Procedural guidelines for appointing assessors and co-assessors	With leads. LB in favour of engaging.
11/04/2022	CIOMS Working Group XI Draft report	Waiting for feedback from leads about engagement.
11/04/2022	EMA consultation: DRAFT Qualification opinion for the use of Enroll-HD (a Huntington’s disease patient registry) as a data source and infrastructure support for post-authorisation monitoring of medical products	Checking relevance with leads (PP & DM)

Next policy call – Wednesday, 30th of March at 2 PM CET?