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