Mission Statement
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.
The Group
Chair: Helen Barker
Director Regulatory Affairs – Blue Earth Diagnotics
Vice-Chair: Cristiana Gameiro
Product manager – IBA RadioPharma Solutions
Supervisor: Lutz Helmke
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
Krzystof Chrustowski
Quality Manager – RC POLATOM
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
Inger Torgersen
Global Regulatory Leader – Bayer Pharmaceuticals
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