NMEU Regulatory Affairs Expert Group represents the member companies on current, pending and proposed pharmaceutical legislation, regulations, specific guidelines, etc.
The Expert Group plays a significant role in permanently monitoring these pending and proposed documents on both national and EU level.
If there are issues which could have an impact on our business, the group may take proactive lobbying actions to the European Parliament, the European Commission, the national and the EU competent health authorities, as relevant. The group drafts position papers and aims to influence the decision making through its contacts with the key regulatory and legislative staff.
On a regular base, it provides members with news and relevant documents issued by EU institutions and affiliated committees concerning pharmaceutical legislation and market issues. The Expert Group discusses regulatory topics of mutual interest and aims to agree on common positions for responses to authorities.
Since its creation, the Regulatory Affairs Expert Group, has known a continuous growing importance and has successfully completed important lobbying actions.
Chair: Helen Barker
Director Regulatory Affairs – Blue Earth Diagnotics
Vice-Chair: Cristiana Gameiro
Product manager – IBA RadioPharma Solutions
Supervisor: Lutz Helmke
Vorstand Segment Radiopharma – Eckert & Ziegler
Regulatory Affairs Manager – IRE
Director Regulatory Strategy and Relationships Quality & Regulatory – GE Healthcare
Head of Regulatory Affairs, Europe – Telix Pharmaceuticals
Global Head Regulatory CMC – AAA-Novartis
Quality Manager – RC POLATOM
Vice President, Global Public Policy and Government Relations – Lantheus Medical Imaging
Director, Commercial Operations Canada, Asia, Europe – Jubilant Radiopharma
Clinical Project Manager, Deputy QPPV – Rotop Pharmaka
Global Head Regulatory Affairs – AAA-Novartis
Head Of Regulatory Affairs, QPPV (EU/NAT) – Rotop Pharmaka
Senior Regulatory Affairs Specialist, S.C. – Monrol Europe SRL
Head of Quality medical imaging – Rotem Industries
Quality Department – Lantheus Medical Imaging
Owner and Principal Consultant – RegulaNova Sarl
Head of QA/RA PETNET International – Siemens Healthcare GmbH
Global Regulatory Leader – Bayer Pharmaceuticals
Sandra van Leeuwen
Sr. Manager Regulatory Affairs (Head Regulatory Affairs) – Curium Pharmaceuticals
Konrade von Bremen
CEO – Swan Isotopen
VP Global Regulatory Affairs – Telix Pharmaceuticals
Head of Regulatory and Quality Assurance – Eckert & Ziegler