Workshop Sessions review – EANM EARL – Research4Life

SIMPLERAD Workshop - Sessions review

The SIMPLERAD Workshop Proceedings can be accessed here.

Session 1 - Opening & Setting the Scene

Welcome and Opening
- Georgi Simeonov (DG ENER) & Bernd J. Krause (SIMPLERAD)

Introduction to the SIMPLERAD project
- Bernd J. Krause (SIMPLERAD)

Presentation of the European framework relevant to therapeutic radiopharmaceuticals
Euratom framework
- Georgi Simeonov (DG ENER)
Pharma framework
- European pharma legislation
  - Paolo Erba (DG SANTE)
- Clinical trials legislation
  - Ann Marie Janson Lang, (Clinical Trials Coordination and Advisory Group)
- Guidance and posology
  - Vanessa Fradin-Da Ros (European Medicines Agency)
Perspectives of international organisations
- World Health Organisation
  - Luther Gwaza
- International Atomic Energy Agency
  - Aruna Korde
- International Commission on Radiological Protection
  - Augusto Giussani

Session 2 - Interrelations among Legal and Regulatory Frameworks [WP1]

Results of analytical work and identified regulatory and implementation issues
- Manuel Bardiès (SIMPLERAD)

Presentation of the outcome of comparative analysis of the legal bases in the United States, United Kingdom and EU
- Michael Lassmann (SIMPLERAD)

Legal basis in the United Kingdom
- Louise Fraser (UK Administration of Radioactive Substances Advisory Committee)

Session 3 - Survey and Expert Interviews on European Legal Requirements [WP2]

Presentation of survey methodology and results of questionnaires and expert interviews
- Jonathan Gear (SIMPLERAD)

Member-state field reports and good-practice examples
- Germany
  - Alexander Drzezga (German Commission on Radiological Protection)
- Sweden
  - Anna Sundlöv (Swedish Medical Products Agency)
- Czechia
  - Pavel Solný (Czech Society of Nuclear Medicine)

Wrap-up and conclusions, Day 1
- Michael Lassmann (SIMPLERAD)

Session 4 - Recommendations to Advance Coherent Implementation of European Legal Requirements [WP3]

Welcome to day 2 & introduction of programme
- Michael Lassmann (SIMPLERAD)

Identification and prioritisation of issues
- Frederik Verburg (SIMPLERAD)

Identified actions to be implemented as part of the project and proposed for the future
- Michael Lassmann & Manuel Bardiès (SIMPLERAD)

Session 5 - Roundtable Discussion on SIMPLERAD Guidance Document and Recommendations [WP3]

Introduction
Round table panel statements:
- European Commission: Georgi Simeonov (DG ENER)
- European Medicines Agency: Vanessa Fradin-Da Ros
- Nuclear medicine therapy expert: Ken Herrmann (SIMPLERAD)
- Medical physics expert: Steffie Peters (SIMPLERAD)
- Radioparmacy expert: Marianne Patt (SIMPLERAD)
- Patient representative: Erik Briers (Europa Uomo)
- Industry: Leonhard Schätz (Novartis Pharma AG)

Session 6 - Summary

Conclusions and recommendations per proposed action
- Michael Lassmann (SIMPLERAD)

Summary and wrap-up per project task
- Michael Lassmann (SIMPLERAD)

Next steps in the project & closing
- Monika Hierath (SIMPLERAD) & Georgi Simeonov (DG ENER)