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: Konrade von Bremen
CEO – Swan Isotopen
David Barnes
Business Unit Director – RLS
Marjorie Blot
Regulatory Affairs Manager – IRE
Cláudia A. Coelho
Head of RA Global Regulatory Leads Marketed Products – GE Healthcare
Françoise Bruyère
Senior Manager, GRA Strategy – EMEA – Telix Pharmaceuticals
Camelia Cercel
Global Head Regulatory CMC – AAA-Novartis
Krzystof Chrustowski
Quality Manager – RC POLATOM
Budhesh Dhamija
Head of Clinical Regulatory Affairs – ITM Radiopharma
Ira Goldman
Vice President, Global Public Policy and Government Relations – Lantheus
Eric Guilbert
Director, Commercial Operations Canada, Asia, Europe – Jubilant Radiopharma
Elisabeth Guillaut
Manager European Affairs – Orano Chemistry Enrichment
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
Regulatory Affairs Manager – Monrol Europe SRL
Pini Cohen Segal
Head of Quality Assurance – Rotem Industries
Lynn Mendonca
Quality Department – Lantheus Medical Imaging
Izabela Rejdych
Owner and Principal Consultant – RegulaNova Sarl
Jan Spieler
Head of QA/RA PETNET International – Siemens Healthcare GmbH
Inger Torgersen
Global Regulatory Leader, Oncology Regulatory Affairs Strategy – Bayer Pharmaceuticals
Sandra van Leeuwen
Sr. Manager Regulatory Affairs (Head Regulatory Affairs) – Curium Pharmaceuticals
Rob Vermeulen
Director Regulatory Affairs – Janssen Cilag International
Konrade von Bremen
CEO – Swan Isotopen
Mike Wardach
VP Global Regulatory Affairs – Telix Pharmaceuticals
Deljana Werner
Head of Regulatory and Quality Assurance – Eckert & Ziegler