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: Konrade von Bremen
CEO – Swan Isotopen
Business Unit Director – RLS
Regulatory Affairs Manager – IRE
Cláudia A. Coelho
Head of RA Global Regulatory Leads Marketed Products – GE Healthcare
Senior Manager, GRA Strategy – EMEA – Telix Pharmaceuticals
Global Head Regulatory CMC – AAA-Novartis
Quality Manager – RC POLATOM
Head of Clinical Regulatory Affairs – ITM Radiopharma
Vice President, Global Public Policy and Government Relations – Lantheus
Director, Commercial Operations Canada, Asia, Europe – Jubilant Radiopharma
Manager European Affairs – Orano Chemistry Enrichment
Clinical Project Manager, Deputy QPPV – Rotop Pharmaka
Global Head Regulatory Affairs – AAA-Novartis
Head Of Regulatory Affairs, QPPV (EU/NAT) – Rotop Pharmaka
Regulatory Affairs Manager – Monrol Europe SRL
Pini Cohen Segal
Head of Quality Assurance – 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, Oncology Regulatory Affairs Strategy – Bayer Pharmaceuticals
Sandra van Leeuwen
Sr. Manager Regulatory Affairs (Head Regulatory Affairs) – Curium Pharmaceuticals
Director Regulatory Affairs – Janssen Cilag International
Konrade von Bremen
CEO – Swan Isotopen
VP Global Regulatory Affairs – Telix Pharmaceuticals
Head of Regulatory and Quality Assurance – Eckert & Ziegler