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

Hatice Erkan, Regulatory Affairs and Pharmacovigilance Manager – Monrol Europe

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

Sibylle Jennings Global Head Regulatory Affairs – AAA-Novartis
Camelia Cercel, Global Head Regulatory CMC – AAA-Novartis

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

Hiba Soulaihi Manager Regulatory Affairs – Jubilant Draximage

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

Marjorie Blot, Regulatory Affairs Manager, IRE

Julien Thonnart Head of Production & Supply Chain – IRE – Elit

Tapashi Dasgupta Manager, Global Regulatory Affairs – BWXT

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

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

Jeffrey Bourque, Director, Global Regulatory Affairs, Lantheus Medical Imaging

Shirley Jarvill, Lantheus Medical Imaging

Konrade von Bremen, CEO Swan Isotopen

Vera Lazebny, Head of Quality – Medical Imaging – Rotem Industries

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