11 August 2021

1) CTF

Meeting with DG GROW

• Please let me know which dates/times would be suitable for you. We should send a selection to DG GROW.

Call with Ian

• Ian would like to talk with PH/AS and the staff to discuss about next steps. GML suggested to schedule the call after our exchange with DG GROW.

2) Policy updates

FIP exchanges & next meetings

• Meeting with European region: @ PH – anything noteworthy? Any comments on the documents that were shared (Meeting report HERE | ANNEX A – Slides of the meeting see HERE | ANNEX B – Chat Log of the meeting see HERE)
• Follow-up on pandemic preparedness: As agreed during the last policy call, we will wait to hear back from FIP.
• WPD pictures: Pictures were submitted. SK will also promote them on EAHP’s social media accounts.
• FIP-UNESCO UNITWIN Regional Workshops: FIP send a newsletter invitation linking to the UNITWIN project (see HERE). The meeting for the European region will take place on 20 October 1 to 3 PM CET. Should we participate?
• 23 August webinar: (see below under point 4 – Speaking engagements President)

Funding

• EU4Health – first calls for proposals to beat cancer and boost crisis preparedness: The proposal was published (see HERE). At the last policy call we tentatively looked at the topic “Action grants on substances of human origin (SoHo) – Increase resilience, ensure continuity of supply and access to safe and high quality therapies, in particular in times of crisis”. Due to the tight staff situation and taking into account all the other activities that need to be organised in August/September (procurement event, oath to society launch, changing roles campaign, Board meeting preparation, ECPhA, day-to-day policy work) it is very difficult to work on a proposal until the 15 September deadline.
• Horizon Europe: The calls are available HERE. Deadline for submission is 21 September but even more preparation than for the EU4Health would be needed.

Preparation of position paper discussion for 2022

• SK reached out to the different leads (medical devices/clinical trials & PH/AS for workforce and ATMPs). Deadline for feedback was July. So far, only LB replied.

Follow-up April Board meeting

• Board leads were tasked to work on the following for the September meeting: Survey guide (AB/DM), feedback on IV therapies (PH/AB), Surface contamination of hazardous products (DM). No significant progress has been made, apart from AB reaching out to SA for input. I will keep trying but it might be difficult to prepare everything for September.

Clinical trial Regulation (NVZA request – in discussion with trial leads)

• Background from last policy call: NVZA reached out to us about the Clinical Trial Regulation implementation (see HERE). PP & AB agreed that it could be good to get feedback from all our members. DM still has not replied. (Additional note the clinical trial regulation will apply from 31/01/22 onwards.) Can SK go ahead and start contacting members about the implementation?

COWI study – Joint EAHP-ESOP Statement for COM

• @ AB do you have any additional comments (see PH’s and AS comments HERE). SK will provide feedback on the comments during the policy call.

EDQM -Traceability of Medicines is Hospital Settings

• EDQM is looking for a ‘consultant’ that could help with the traceability project (see HERE). 

Oaths to society – launch event

• SK is waiting on ESCP to confirm the new date of the launch event since none of the dates in mid-October would work for all 3 ESCP representatives. Bart proposed to move to 13th October and have Derek join virtually. Derek cannot do the 13th (as indicated in a previous email), plus virtual live participation might not be feasible at the venue, we could opt for a video message from Derek. @ AS – what are your thoughts?

Procurement event

• @ AB & AS – any back-up solutions for Round table I in case Prof Simeon cannot provide us with a name?
• @ AB – did you hear back from Antonio?
• @ AS – when do you want to talk about the opening/closing remarks?

ECPhA – feedback for GML

• @ PH & AS – did you have time to review the information on Teams?
• @ PH & AS – did you start thinking about the second person that should be EAHP’s representative on the ECPhA Board together with Nenad? 

Speaker request Korea

• @ AS – did you hear back from your colleague that you wanted to contact?

ASHP – new President-Elect

• Paul C. Walker is the new President-Elect. For ASHP, we usually wait with sending congratulations until the person takes office. Ok to do the same with Mr Walker?

Forecasting demand for medicinal products in the EU/EEA

• Background from last policy call: Last year I exchanged with Rob about demand forecasting since he had some information about this due to his engagement in the Dutch (COVID) Medication Coordination Centre (LCG). He reached out again today (see email HERE). There won’t be much movement from mid-July to mid-August, thus we could dive into this once SK is back from holidays. Emails could already be sent to Ivana (EMA) and Sylvain (COM) to get some more insights.
• SK will work on this in August.

SIFO endorsement request

• Any action that should be taken (see emails HERE) 

3) Consultations – state of play

Due date	Type of consultation	Action
17/08/2021	Consultation_draft Questions and Answers on Articles 13 &14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746	Waiting for feedback from AB & DM.
25/08/2021	PGEU – 2021 Audit	As discussed during the last policy call, not worthwhile to engage.
28/08/2021	Targeted consultation – EU4Health Annual Work Programme 2022	Only DKP shared feedback.
31/08/2021	EMA – Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials	Waiting for feedback from PP & DM.
31/08/2021	EMA – Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials – draft	Waiting for feedback from PP & DM.
03/09/2021	COM – Data Act & amended rules on the legal protection of databases	SK reviewed, no direct relevance for health policy. Focus in mainly on B2B activities.
03/09/2021	COM Medical devices: Q&A on UDI system – DDL	Waiting for feedback from DM & AB.
22/10/2021	EMA – Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals – step 2b	Waiting for feedback from DM.
24/10/2021	EMA consultation: ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products – Step 2b	Waiting for feedback from DM.
31/10/2021	EMA – Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells	Engagement to be discussed.
17/12/2021	EMA consultation: Guideline on computerised systems and electronic data in clinical trials	Shared with DM and PP.
20/12/2021	EMA – ICH guideline Q13 on continuous manufacturing of drug substances and drug products – Step 2b	Engagement to be discussed.

4) Speaking engagements President

FIP Webinar “Advanced and Specialist Pharmacist Development for Hospital Pharmacists” (23 August 2021 | 10 CEST)
@ AS – do you need help with the learning objectives and the slides? This links to you presenting EAHP’s HP specialisation position paper

SEFH Plenary Session “Hospital pharmacy 2030. Opportunities and professional development” (20 October 2021 – recording taking place on 23 September)
@ AS – do you need time with the preparation?

PGEU Annual Conference (27 October 2021)
@ AS – when do you want to start the preparation for your panel debate intervention?

ASHP Midyear Clinical Meeting (Adapting International Pharmacy Practice to the New Normal in the Wake of a Global Pandemic)
Slides need to be prepared by 20 September. @ AS do you need assistance?

Next policy call – Wednesday 25^th of August at 2 PM CET?