REGULATORY WRITING

09.00–12.30

Introduction

Putting the CSR in Context 

• The CTD regulatory pyramid
• The summary of the CSR

Presenting The Methods

• Including the protocol
• Including the statistical analysis plan
• Dealing with protocol amendments

Describing the Study Population

Presenting Efficacy Data and the Pharmacokinetic Data

Lunch

13.30–17.00

Presenting Safety Data

• Adverse events
• Laboratory data
• Other safety data

Writing Narratives

Finishing Off the CSR

• Discussion
• End-of-Text Tables and Figures
• Appendices
• Compiling the CSR

Trouble Shooting

17.00

Close (approx)

09.00–12.30

Protocol Writing

• Getting started - rules and regulations
• Protocol development process - key tasks and team members
• CRF/protocol relationship
• Study design
• Protocol summary
• Format and layout of protocol
• Appendices
• Protocol amendments
• Hot to review a protocol

12.30-13.30

Lunch

13.30–15.00

Investigator Brochures

• What should be included and why
• Format and layout of an IB

Review and QC

• How to review a document and provide feedback
• What QC does and doesn't include

15.00

Close (approx)