CRED Clinical Trials - Day 1 handouts

Time 13.05

Session/ Activity

Presenter

Early studies in man: What can we achieve? • Early drug development

Malcolm Boyce Hammersmith Medicines Research

Study design

• Assessing and reducing the risk to the subject Paediatric clinical trials - Considerations for Industry • Timing re the EU PIP process (we won’t go into specific of PIP, but cover how the process impacts on timing of conducting paediatric trials)

Paolo Tomasi EMA

13.45

Considerations for conduct of trials in children. Additional requirements for paediatric trials – pre-clinical and clinical

Tea and Coffee break Clinical Development • Study design

14.15 14.30

Matt Scullion Janssen Pharmaceutical

Comparators

• How other groups interact with regulatory in clinical development Case study (45 mins) Feedback (15mins) This case study will be an interactive presentation, with material on clinical trial requirements provided to participants in advance

15.15

Shaila Choi Janssen Pharmaceutical

Janneke Westra Janssen Pharmaceutical

Panel discussion

16.15

16.45

Close of day 1

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