Regulatory Affairs

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.

REGULATORY AFFAIRS & QUALITY WORKING GROUP

Helen Barker, Chair
Director Regulatory Affairs, – Blue Earth Diagnotics

Cristiana Gameiro, Vice-Chair
Product manager – IBA RadioPharma Solutions

Lutz Helmke, Supervisor Executive Committee
Vorstand Segment Radiopharma – Eckert & Ziegler

 

Marjorie Blot Regulatory Affairs Manager – IRE

Peter Bradley Director Regulatory Strategy and Relationships Quality & Regulatory – GE Healthcare

Françoise Bruyère Head of Regulatory Affairs, Europe – Telix Pharmaceuticals

Camelia Cercel Global Head Regulatory CMC – AAA-Novartis

Ira Goldman Vice President, Global Public Policy and Government Relations – Lantheus Medical Imaging

Eric Guilbert Director, Commercial Operations Canada, Asia, Europe – Jubilant Radiopharma

Susan Hoppmann Clinical Project Manager, Deputy QPPV – Rotop Pharmaka

Sibylle Jennings Global Head Regulatory Affairs – AAA-Novartis

Franziska Klein Head Of Regulatory Affairs, QPPV (EU/NAT) – Rotop Pharmaka

Demet Kökoğlu Senior Regulatory Affairs Specialist, S.C.  – Monrol Europe SRL

Vera Lazebny Head of Quality medical imaging – Rotem Industries

Lynn Mendonca Quality Department – Lantheus Medical Imaging

Izabela Reydich Owner and Principal Consultant – RegulaNova Sarl

Jan Spieler Head of QA/RA PETNET International Siemens Healthcare GmbH

Sandra van Leeuwen Sr. Manager Regulatory Affairs (Head Regulatory Affairs) – Curium Pharmaceuticals

Konrade von Bremen CEO – Swan Isotopen

Mike Wardach VP Global Regulatory Affairs – Telix Pharmaceuticals

Deljana Werner Head of Regulatory and Quality Assurance – Eckert & Ziegler

 

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