Clinical Trials Workshop

This 2-day workshop will provide a forum for information exchange and discussion on conceptual and practical questions through lectures and panel discussions.There will be a particular focus on the critical issues affecting sponsors and Member States as they consider the impact and changes needed to implement the regulation.

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Session 3 What is necessary for Efficiency and Standardisation in Safety Reporting from Clinical Trials

Session Chair(s)

Esteban Herrero-Martinez, PhD

Director Regulatory Policy and Intelligence

AbbVie, United Kingdom

This session aims to highlight the key issues and concerns identified for safety reporting from different stakeholders (commercial and academic sponsors). The session will also outline the Role of CTFG in developing thinking around co-ordinated safety assessment and provide an update from the EMA on the progress towards a clinical trial safety database.

Speaker(s)

Implementing Safety Reporting Provisions in the EU-CTR – the Industry View

Esteban Herrero-Martinez, PhD

AbbVie, United Kingdom

Director Regulatory Policy and Intelligence

Towards Implementation – Member States Cooperation in Safety Assessment

Elke Stahl, PhD

Federal Institute For Drugs and Medical Devices (BfArM), Germany

Senior Expert, Clinical Trials Department

EU-CT Regulation – Update on Safety Reporting Systems

Sophia Mylona

European Medicines Agency, Netherlands

Scientific Administrator, Compliance and Inspection

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Clinical Trials Workshop

Session 3 What is necessary for Efficiency and Standardisation in Safety Reporting from Clinical Trials

Session Chair(s)

Esteban Herrero-Martinez, PhD

Speaker(s)

Implementing Safety Reporting Provisions in the EU-CTR – the Industry View

Towards Implementation – Member States Cooperation in Safety Assessment

EU-CT Regulation – Update on Safety Reporting Systems

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