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

Hatice Erkan, Chair Regulatory Affairs and Pharmacovigilance Manager – Monrol Europe

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

François Labarre, XCO rep Supervisor Vice President Northern Europe, Curium

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

Camelia Cercel Manager Regulatory Affairs – AAA

Annette Stolz Global Head Government Affairs -AAA

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

Hiba Soulaihi Manager Regulatory Affairs – Jubilant Draximage

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

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

Tapashi Dasgupta Manager, Global Regulatory Affairs – BWXT

Vincenzo Cannizzaro RA -Global Regulatory Leader -Medical Services – GE Healthcare

Helen Barker Director Regulatory Affairs, – Blue Earth Diagnotics

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

Jeffrey Bourque Director, Global Regulatory Affairs

Shirley Jarvill Lantheus Medical Imaging

Konrade von Bremen CEO Swan Isotopen

Sarit Segal Rossman QA Manager, Medical Imaging – Rotem Industries