CRED Clinical Trials - Day 1 slides

CRED: Clinical Trials 22-23 November 2017 DoubleTree Hilton Victoria, 2 Bridge Place, Victoria, London SW1V 1QA Day 1 Clinical Trial applications: Overview and practical aspects Chairperson: Peter Sallabank

Time 09.00 09.30

Session/ Activity

Presenter

Registration and Coffee Welcome from TOPRA

Samantha Alsbury TOPRA Peter Sallabank Regulinx

09.35

Introduction to the next 2 days

Clinical Trials Applications - the past, the present and the future • A brief history of the current CT Directive

09.40

Liz Gifford Eisai

The VHP pilot

• The future – the new CT Regulation Overview of the EU CTA and the IMPD dossier and how to maintain your CTA Tea and coffee break around 10.30 (flexible)

Chris Parkinson GlaxoSmithKline

09.55

Stephen Thompson S Cubed

Initiation of clinical trials: What is in and what is out of the scope of the current legislation?; study start-up - what to do and what not to do CMC, preclinical and clinical data requirements to support each stage of development; CTA preparation: CTA’s full IMPD; simplified IMPD; IMPD for marketed products; ‘Hot topics’ in IMPD assessment; IMPD maintenance; Considerations for study start up: Source of the IMP, packaging, timelines and logistics Maintenance of the CTA: how to navigate the bumps and pitfalls; Amendments; Temporary halts; Safety reporting; What happens at the end of the study? Reporting obligations; What happens to patients following completion of the study?

Lunch

12.15

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