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

Nadine Galonde
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

Antonio Brancaleoni
Tema Sinergie

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