Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

8 Jul 2025 · Biotech

Response to Proposal for a Regulation of the European Parliament and Council to foster biotechnology in Europe

10 Jun 2025

Meeting with Olivér Várhelyi (Commissioner) and 3 other attendees

10 Jun 2025 · Preparation for the upcoming Biotech Act

Meeting with Jessica Polfjärd (Member of the European Parliament)

6 Jun 2025 · Health Policy

Response to Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the “Strategy for European Life Sciences”

17 Apr 2025

Response to COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level

28 Oct 2024

Meeting with Stine Bosse (Member of the European Parliament, Committee chair)

19 Sept 2024 · European health policy

Meeting with Michael Kauch (Member of the European Parliament)

30 May 2024 · General exchange

Response to COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments

2 Apr 2024

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

8 Nov 2023 · Pharma-Revision (staff level)

Response to Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

7 Nov 2023

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Novo Nordisk A/S

20 Sept 2023 · Directive on Medicinal products for human use

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

19 Sept 2023 · Exchange of views with the Alliance for Regenerative Medicine on the implementation of the HTA Regulation as well as the reform of the EU Pharmaceutical Legislation.

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

21 Feb 2023 · SoHO

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur) and International Plasma and Fractionation Association

24 Nov 2022 · SoHO regulation

Response to Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC

8 Sept 2022

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

27 Jan 2022 · Exchanges of views on policy priorities of the Alliance for Regenerative Medicine in Europe: the Pharmaceutical Strategy and the EU’s Beating Cancer Plan

Response to Report from the Commission to the EP and Council on the operation and performance of the Directive 2011/24/EU on the application of patient rights in cross-border healthcare foreseen under Article 17(1) and Article 20(1) & (2) of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011

11 Feb 2021

Response to Proposal for Regulation [tbc] on the European Health Data Space, digital health services and products and the use of new technologies, including artificial intelligence (AI) in health

3 Feb 2021

Response to Revision of Directive 2002/98/EC on safety and quality of human blood and blood components and of Directive 2004/23/EC on safety and quality of human tissues and cells and their implementing acts.

14 Dec 2020

Response to Commission Communication on a Pharmaceutical Strategy- Ensuring sustainable innovation and the availability and affordability of medicines and medical technologies for citizens

6 Jul 2020

Response to Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products

7 Jan 2018

Response to COMMISSION REGULATION (EU) …/… amending Regulation (EC) No 847/2000 as regards the definition of the concept 'similar medicinal product'

27 Nov 2017

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

8 Nov 2017 · Advanced therapy medicinal products