25 October 2021

1) CTF

Meeting with DG GROW

No feedback from GROW yet. SK will follow up with them again on 26/10.

Steering Committee/WG chair – involvement desire

@ AS, AB and PH – do you have feedback on GMLs email (see email HERE & project overview HERE)? When should we meet with the chairs?

2) Policy updates

FIP exchanges & next meetings

European Regional meeting (3 November): AS will attend
Pandemic preparedness exercise: FIP shared the document they are collecting input with (see HERE). Feedback should be shared by mid-November. If you agree, SK will reach out to the FIP/COVID leads for input. The office would already include some information based on what we have at hand.
FIP interview with EAHP: Interview was declined. No feedback received from FIP.
UNITWIN Regional Workshops: AB did the workshop planned for October for which you were registered already take place?

Procurement event follow-up
GML & SK are working on the notes from the meeting. These will be shared with a survey with all participants. The speakers will get another thank you via email.

COM work programme 2022
The programme can be accessed HERE. For the health field there are no surprises.

Questions for AS

Oaths to society launch follow-up
@ AS – what is your available from 10 November onwards? The first week of November does not work for Bart for a follow up meeting.

Follow up EFCCA meeting
@ AS – how would you like to follow up on the EFCCA meeting? SK is already working on the outline for an article to introduce EAHP in their publication.

Brussels trip in November
@ AS – Are you still considering coming to Brussels? If yes, when so that meetings can be set up.

Meeting with AIM
Before our Oath event Sybille from AIM (she was one of our speakers at the Oath event) contacted JDG to organise a meeting since policy responsibility for the large majority of EU associations lies with the MD/COO. @ AS – to build on our engagement at the Oath, I would turn this meeting request into a (virtual) meeting with you and me. When would you have time?

3) Board meeting follow-up & Congress

President’s guest invitations

@ AS do you have feedback for the invitation text sent to you (see text HERE)?
Additions to list – ECDC included | Since they are based in Vienna and we engaged with them last year on radiopharmacy issues, would be interesting to invite EANM (European Association of Nuclear Medicine) as a guest in the 3rd category?

EAHP Award
When would you like to start the brainstorming for the name and the SOP?

4) Consultations – state of play

Due date	Type of consultation	Action
31/10/2021	EMA – Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells	Feedback request shared with entire Board. Deadline 26/10
01/11/2021	COM MDCG – Consultation on draft guidance on in-house devices	Feedback requested from AB & LB.
15/11/2021	COM – Open Public Consultation on the Targeted Revision of the Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP)	DM & AB suggested to engage. SK is preparing 1st draft.
08/12/2021	EMA consultation: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – addendum.	Waiting for response from DM. PP deems the topic relevant but not the consultation.
17/12/2021	EMA consultation: Guideline on computerised systems and electronic data in clinical trials	Both PP and DM agree to engage. Feedback request will be shared with entire Board in late October.
20/12/2021	EMA – ICH guideline Q13 on continuous manufacturing of drug substances and drug products – Step 2b	Feedback request will be shared with entire Board in late October.
21/12/2021	COM – Public Consultation: Revision of the EU general pharmaceuticals legislation	SK is preparing 2nd draft. Call with shortage and access leads on 26/10.