16 July 2020

1) CTF

Exchange with IB

• GML scheduled the exchange on 28 July at 5 PM CEST. @ PH and AB: Do you have any additional points to add to the discussion item list (see HERE)?

Request EUPLMG

• @PH and AB – how would you like to respond to the additional information EUPLMG shared with us (email see HERE)? We discussed this topic initially during the January Board meeting. 

2) Policy updates

FIP – Council Meeting

• AB, DM and PP expressed interest to attend. SA could also make himself available if needed.

COM event for pharmaceutical strategy

• @ AB and PH – how was the event? 

WHO Consultation

• The response document is included HERE. @ PH and AB – do you have any additional points to add?

ESOP – MoU + conference call

• ESOP has signed the MoU. The conference call is tentatively schedule for 23 July at 4 PM (or later). @ PH + AB – would that work for both of you?

Update on EMA activities and requests

• COVID-19 pool: 2 expressions received. SK will collect a few more before reaching out to EMA. She will continue to submit names to EMA throughout the summer.
• COVID-19 expert nomination (EMA deadline 24 July): PH, AB and SA provided feedback. Reminder sent to Board.
• Call for expression of interest for nomination of experts to participate in a virtual meeting on “Artificial intelligence in clinical trials – ensuring it is fit for purpose” (22 September): JP and TS don’t have any expertise; call was shared with the rest of the Board. 
• EMA virtual Workshop on benefit-risk of medicines used during pregnancy and breastfeeding (22 September): waiting for feedback from PP and DM
• EMA virtual annual training day: name of the EAHP attendee can be shared after the GA.

Meeting with Commissioner Kyriakides

• Still no feedback.

Coalition for Vaccination – invitation to the Advisory Board

• NM agreed to engage. SK has shared his nomination with CPME. 

Hazardous drugs – conference

• The conference will be held virtually. JP was contacted again. Maria Jose Tames (suggestion of DM) expressed interest and was informed that the event is now virtual. SK is waiting for feedback from both.

EFCP – video for WPD

• Mahmoud shared the following about the video message for the WPD: The message could be 30 mins or less. It may contain the following: Congratulations on WPD | Role of pharmacist during the worldwide pandemic | EAHP, its members, constitution as a global partners, its role and how it acts for a better career for all pharmacist and possibility of EFCP becoming a member.
• @ PH do you need help with putting something together?

FMD call with members

• The call was held on 14 July to discuss the user requirement specifications of EMVOs alert handling tool. 17 countries registered and 14 ended up joining. A report will be put together and shared with all FMD countries. 

POLITICO Health Care Summit Speaker update

• @ PH – did you see the email (see HERE) from Politico? Are you fine with the timing for your session indicated in draft agenda (see HERE)?
  Title: SPOTLIGHT DISCUSSION 1: Looking at the roots of medicines shortages
  Time and date: 10:45 am – 11:20 am, November 18
  Other speakers: Kasper Ernest, secretary general, Affordable Medicines Europe

3) GA documents

Patient safety position

• Marta revised the image (see HERE). @ PH – is it now closer to what you had in mind?

4) Consultations – state of play

Due date	Type of consultation	Action
mid-July 2020 (no clear deadline)	WHO – Online open written consultation on the European Programme of Work	Finalisation with AB and PH.
22/07/2020	Targeted stakeholder consultation on the pilot project ‘Market Launch Intentions of Centrally Authorised Products’	Submitted.
30/07/2020	EMA – Q3C (R8): Impurities: guideline for residual solvents	TS advised against engaging.
31/07/2020	EMA – Draft Guideline on registry-based studies	TS is reviewing the document.
04/09/2020	EMA-HMA network strategy	JP and TS are reviewing the first draft.
15/09/2020	COM: Public consultation – Pharmaceuticals – safe and affordable medicines (new EU strategy)	Leads were informed. Preparatory work will start in July.
03/10/2020	EMA – ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk	JP and TS advised against engaging.

Next policy call – Before SK’s holidays (starting 30/7)? Or in mid/late August?