7 February 2023

1) CTF

Meeting with DG Grow
GML will give an update. AS & PH still need to include their availability via the doodle.

CTF chairs
@ AS – did you contact the previous chairs that we would like to replace?

2) Policy updates 

EHMA Alliance Position Paper
@ AS – can this be shared with the rest of the Board for endorsement?

[INTERREG] Cross-border pharmaceutical cooperation project
@ AS – any specific follow-up requested? (“We have taken note of your wish not to participate in the project as an associated operator. Interreg VI programme does not define an “observer” status. However we could keep Louis Bertin informed of the project’s progress. I would like to draw your attention to the fact that it may not be possible to join the project at a later stage, as we are subject to the regulations of the Interreg VI programme, which require us to define the perimeter and partners at the pre-project stage.”)

EPSA Annual Reception
@ AS & DKP – is one of you planning to join the reception (28 March 14.30 to 18.30 in the European Parliament)

Request MEP Paulus (Greens) | COVI Committee Report
MEP Paulus invited EAHP to give feedback on the “Global Dimension of the Covid19 Pandemic, including Intellectual Property Rights and One Health”. Feedback will feed into the COVI Committee Report to be adopted in July. @ AS – should EAHP share written feedback?

Exchanges with SANTE
@ AS & DKP – should SK continue to set up a call with digital health unit? So far, no response was received.

EFPIA/MfE FMD workshops
@ AS – PGEU is considering not attending anymore and asks if EAHP would consider doing the same.

Act4Biosimilar
@ AS – will you follow up on this with the Board leads? 

Open items
Please respond to the following overdue emails:
AS/DKP – Barcoding questions shared with digital health leads as follow-up from EFPIA exchange
DKP – call with Taiwan  

Reminder
PH – the feedback to the EDQM consultation is due on 10/2

3) Congress

President’s Guest meetings
@ AS – do you have any specific points that you would like to discuss with your guests? (Pharmacy Organisations: ESCP, PGEU, PCNE, FIP, EPSA, ESOP, EAFP, ASHP | International organisations: Egypt, Australia | EU/European institutions: EMA, EDQM | Other organisations: EPF, ESCMID, EFCCA, EANM, GS1, EFIC)

4) Consultations – state of play

Due date	Type of consultation	Action
10/02/2023	EMA – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin	PP recommendation not to engage.
26/02/2023	EMA – ICH M11 guideline on Clinical Electronic Structured Harmonised Protocol and template	PP recommendation to engage. Feedback after ASHP.
14/03/2023	COM – Urban wastewater treatment update & Surface and groundwater pollutants	Feedback in preparation.
15/03/2023	COM – Revision of rules on packaging and packaging waste	Analysis of Regulation.
15/03/2023	COM – Revision of EU legislation on hazard classification, labelling and packaging of chemicals	Analysis of Regulation.
31/03/2023	EDQM – Pead Forum: draft monograph on a Chloral Hydrate Oral Solution	Shared with Board leads.
31/05/2023	EMA – Reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances	Shared with EMA & ATMP Board leads. Awaiting feedback.

Next policy call? 22 February 2023?