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 4 Challenges Anticipated for the Transition Period

Session Chair(s)

Juliette L Kirk

Director, Business Process Owner – Clinical Trial Applications

Pfizer Global Research & Development, United Kingdom

There are a series of transition periods for the CTReg - use of the CTDir and CTReg for one year after entry into force of the CTReg, trials approved under the CTDir continuing to run under the CTDir for three years after entry into force of the CTReg. Running trails and ensuring their compliance with relevant requirements during this period may be a challenge. A thought-provoking session will be hold to include perspectives from industry, compliance/enforcement within MS, and a non-commercial sponsor.

Speaker(s)

Perspective of a Non-Commercial Sponsor

Anastassia Negrouk

EORTC, Belgium

Head of International Policy Office, DPO

Perspective of a Commercial Sponsor

Juliette L Kirk

Pfizer Global Research & Development, United Kingdom

Director, Business Process Owner – Clinical Trial Applications

Perspective of a Member State

Kristof Bonnarens, MPharm

European Commission, Belgium

Policy Officer Pharmaceuticals

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Clinical Trials Workshop

Session 4 Challenges Anticipated for the Transition Period

Session Chair(s)

Juliette L Kirk

Speaker(s)

Perspective of a Non-Commercial Sponsor

Perspective of a Commercial Sponsor

Perspective of a Member State

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