6 March 2019

1) CTF

CTF meeting @ Congress
12 countries (Spain, France, Belgium, Netherlands, Ireland, Czech Republic, Germany, Austria, Romania, Malta, Portugal and Slovenia) have confirmed their attendance. The Slovakian representative pulled out but Juraj will attend and update the authorities after the meeting. Anna Lozano will be presenting the Spanish system. GML is putting together the draft slides for the meeting which will be presented by PH.

CTF WG1
A call will be held with the working group on 14th March. GML and Rahul are preparing the agenda.

Juraj will join the group on behalf of Slovakia. Belgium has not yet taken a decision. GML is in contact with the BE Steering Committee member, Olivia Dalleur.

CTF WG3
A call will be held with the working group on 20th March. It will mainly be used to discuss the role of the WG members in the CTF meeting @ Congress.

2) Policy updates

Medical devices
AB and AS got accepted as members for the 2 medical device subgroups (Borderline & Classification | Unique Identifier) that we applied to.

HTA
Daniel Widmer developed a methodology for the integration of healthcare professionals (HCPs) in HTA processes. So far Elena Petolos (EFPC) and Piotr Szymanski (ESC) commented. See updated draft HERE. Please note that neither Antonio Grasso (PGEU), Carlo Favaretti (EUPHA), Pascal Garel (Hope), Carole Rouaud (CPME) nor SK commented. However, Daniel listed all of them already as contributors.

AMR
SA will be attending the EU JAMRAI Stakeholder meeting on 17th September.

EMA shelf life response
PH, you indicated that you are not satisfied with the response and have follow up questions. What do you want to follow-up on?

FMD
At the EMVO Statutory General Assembly (15th March) we will be discussing the future of the EMVS. RM and Pieter Helmons are currently checking if they can join me since we will also be speaking about hospital logistics and aggregation.

Election manifesto
PH do you have any comments on the manifesto (see HERE)?

GMP Annex 1 update
I shared an email from MfE with you last week about the GMP Annex 1 update (presentation contained therein see HERE). What do we want to do with this request?

Cross-Border Prescription Project
KN received an email inquiring about EAHP’s willingness to participate in a Horizon 2020 consortium looking at cross-border prescription (email see HERE). What is your view? If there is general interest, the policy team can put together a background overview about the requesting entity for the Board.

Brexit – safety measures
RM inquired if we should share safety measures targeting industry? Or is it sufficient just to be aware of these measures? See HERE an example he shared.

EDQM – call with Frederic Broise
SK spoke to Frederic Broise from EDQM about the traceability project. Frederic was out sick for the past couple months and is now back. He plans to discuss this topic at the next meeting of his committee in April. After he will be able to provide us with a detailed project plan. As agreed during the September Board meeting, SK already reached out to the Swiss HP association. Switzerland provided me with the contact details of a pharmacy that is interested in being brought in contact with Frederic. In addition, Frederic would like to receive SOPs/best practices, in case such documents exist, which outline traceability procedures. SK already reached out the RM.

3) Congress

President’s guest meetings
ECCO inquired if they can give a 15 minute presentation at the cancer meeting. I prepared a draft agenda for this meeting (see HERE). Do you agree with the content?

During the pharmacy organisation meeting do you want to cover topics other than an update from the different pharmacy organisations and shortages? See draft agenda HERE.

Do you need an agenda for the meeting with international associations?

4) Consultations – state of play

17/02/19	Public consultation a draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders	Clinical trial board leads
14/03/19	eSource Direct Data Capture (DDC) qualification opinion	Clinical trial board leads + FV No comments so far from FV.
31/03/19	Draft concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury	Short statement expressing agreement.
14/04/19	Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man	Short statement expressing agreement
15/04/19	EMA – Role of big data for evaluation and supervision of medicines in the EU	eHealth Board leads
15/05/19	Guideline on the quality of water for pharmaceutical use	We won’t comment.
31/05/19	Draft guidelines on excipients in the label and package leaflet of medicinal products for human use (see HERE)	eHealth/mHealth Board leads
30/06/19	Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease	Short statement expressing agreement.
30/06/19	EMA discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations	RM and JP
30/06/19	EMA – Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease	Contact Inese | Short statement expressing agreement.
30/06/19	EMA public consultation on a draft guideline on the non-clinical requirements for radiopharmaceuticals	JP to share with Irish HPs
30/06/19	EMA – Regulatory Science to 2025	Policy team + post in EU Monitor
30/06/19	EMA – Draft guideline on quality and equivalence of topical products	RM and KN; if they cannot comment PH will
30/06/19	EMA – concept paper on a guideline for allergen products development in moderate to low-sized study populations	We won’t comment.
31/07/19	EMA revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections	AMR board leads
31/07/19	Public consultation a draft guideline onquality, non-clinical and clinical aspects of medicinal products containing genetically modified cells	Clinical trial board leads
31/07/19	Public consultation – Draft questions and answers on Data Monitoring Committees issues	Clinical trial board leads
31/07/19	Public consultation on key principles for the electronic product information of EU medicines	eHealth board leads
08/08/19	EMA – Public consultation a guideline on clinical investigation of medicinal products for the treatment of gout	Short statement expressing agreement.
31/08/19	Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)	Clinical trial board leads
30/09/19	EMA public consultation on a draft reflection paper on the qualification of non-genotoxic impurities	We won’t comment.
31/10/19	CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products	We won’t comment.

5) Miscellaneous

Medicines for Europe – meeting request
Medicines for Europe would like to meet with representatives from EAHP to discuss common interests (see email HERE). SK emailed them to ask about more details. Maarten is currently on holidays. Therefore no feedback was received yet.

2019 ASHP Midyear Clinical Meeting International Session Call for Proposals
How many topics should we send and who should we nominate for which topic (in case we send multiple):

1. Continued implementation of the Basel Statement principles – where are we now
2. Cross-border initiatives in the field of medicines shortages
3. Sharing of best practices and mentoring at the international level

Please note that for each proposal an abstract needs to be submitted by 3rd May.

EDQM – next CD-P-PH/CMED committee meeting
NM suggested to present EAHP’s opinions/position papers/ projects. In order to link his presentation with the objective of the EDQM meeting he would point out links of EAHPs documents with supply chain issues, patient safety, and bar coding. What do you think?

Publication of ‘old’ position papers in EJHP
The following position papers will be published in the EJHP:

• Statement on Hospital Pharmacy Specialisation
• Statement on Patient Safety
• EAHP Statement on clinical trials
• EAHP Statement on medical device regulation

Do you happen to know who was involved in the drafting of these papers (apart from Richard)? I was planning to also reach out the Kees and to Roberto.

 

Next policy call? Before congress? 20th March?