HMA/EMA multi-stakeholder workshop on shortages

• Date:
  Wednesday, 01 March 2023, 09:00 (CET) - 16:45 (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
• Twitter:
  HMA/EMA multi-stakeholder workshop on shortages

Event summary

The aims of the EMA and HMA workshop on the activities on medicine shortages and initiatives are to:

• inform stakeholders about the HMA/EMA Task Force activities on medicines shortages and availability and interfaces with other initiatives;
• update stakeholders on progress with the Task Force deliverables and identify areas of agreement as well as areas for further discussion;
• share stakeholders’ perspectives and (ongoing/planned) initiatives to address availability issues and discuss how these can contribute to the future deliverables of the Task Force.

HMA/EMA Task Force was established by EU regulators in 2016 to develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe.

Video recordings

Day 1:

Session 1: Setting the scene

 

Breakout session 2A: Immunoglobulins

 

Breakout session 2B: Biosimilars

 

Breakout session 2C: Medicines for veterinary use

 

Day 2:

Welcome and summary of day 1

 

Session 3: Prevention of shortages

 

Session 4: Permanent withdrawals from the market

 

Session 5: Communication and transparency

 

Session 6: Work ahead to 2025

Documents

Agenda - HMA/EMA multi-stakeholder workshop on shortages

Draft

Report - HMA/EMA multi-stakeholder workshop on shortages

Presentation - 1.2 European Medicines Agencies Network initiatives - Lorraine Nolan (HMA)

Presentation - 1.4 Monitoring of events and preparedness for Public Health Emergencies (PHE) - Anthony Humphreys (EMA)

Presentation - 1.5 What happened with the HMA-EMA Task Force on availability of authorised medicines (TF AAM) since 2018

Presentation - 2A.1 Overview of immunoglobulins supply situation in the EU - Klaus Kruttwig (EMA)

Presentation - 2A.2 EU legislation and policy on blood and blood components - Stefaan van der Spiegel (DG SANTE, EC)

Presentation 2A.3 - SUPPLY Project: Availability of IV/SC human normal immunoglobulins in the EU/EEA - Fabio Candura (ISS) Daphne Thijssen-Timmer (European Blood Alliance)

Presentation - 2A.4 Rapporteur session - Emilija Matelytė (EMA)

Presentation - 2B Breakout session - Biosimilars - Steffen Thirstrup (EMA)

Presentation - 2B.1 Work plan of the HMA Biosimilar Working Group (BSWG) - Esa Heinonen (HMA)

Presentation - 2B.2 Scientific rationale for interchangeability of biosimilars in the EU - Elena Wolff-Holz (PEI)

Presentation - 2B.3 HMA-EMA statement on interchangeability of biosimilars - Steffen Thirstrup (EMA)

Presentation - 2B.4 Rapporteur session - Rosa Gonzalez-Quevedo (EMA)

Presentation - 2C.1 Medicines for veterinary use - Nancy de Briyne (FVE)

Presentation - 2C.2 Medicines for veterinary use - Elsa Vecino (Accessvetmed)

Presentation - 2C.3 Medicines for veterinary use - Rick Clayton (AnimalHealthEurope)

Presentation - 2C.4 Medicines for veterinary use - Paule Carnat-Gautier (ANSES)

Presentation - 2C.5 Medicines for veterinary use - Inke Reimer (BVL)

Presentation - 2C.6 Rapporteur session - Janos Kovacs (EMA)

Presentation - 3.1 Prevention of shortages - Ancel.la Santos (BEUC)

Presentation - 3.2 Prevention of shortages - Stephan Roenninger (Industry)

Presentation - 3.3 Prevention of shortages - Jorge Batista (PGEU)

Presentation - 3.4 Prevention of shortages - Nancy De Biyne (FVE)

Presentation - 3.5 Network priorities to 2025 TF AAM workplan - Maria-Jesus Alcaraz Tomas (EMA)

Presentation - 4 Permanent withdrawals of medicinal products from the market - Momir Radulovic (HMA)

Presentation - 4.1 Permanent withdrawals from the market - Charlotte Roffiaen (EPHA)

Presentation - 4.2 Permanent withdrawals from the market - Mary McCarthy (UEMO)

Presentation - 4.3 Permanent withdrawals from the market - Adrian van den Hoven (Industry)

Presentation - 4.4 Permanent withdrawals from the market - Michael Ermisch (GKV-Spitzenverband)

Presentation - 4.5 Permanent withdrawals from the market - Matjaz Marc (JAZMP, SPOC WP)

Presentation - 4.6 Network priorities to 2025 - TF AAM workplan - Joao Ferreira (EMA), Michael Berntgen (EMA)

Presentation - 5.1 Patients’ perspective on communication and transparency - Marko KorenjaK (PCWP)

Presentation - 5.2 Communication and transparency - Jean-François Duliere (Industry

Presentation - 5.3 Communication and transparency - the Healthcare Professionals' perspective - Rosa Giuliani (HCPWP)

Presentation - 5.4 Shortages and communication - paralel timelines - Diego Pernas (AEMSP)

Presentation - 5.5 Network priorities to 2025 - TF AAM workplan - Juan Garcia Burgos, Inga Abed (EMA)