Regulatory Considerations for Global Clinical Development


This course was designed for a European based pharmaceutical company whose regulatory affairs department was responsible for global registration including Europe and the US. They wanted a course to provide regulatory and clinical development personnel with an understanding of key regulatory considerations in the clinical development of a drug. One of the aims was to improve the interactions between the regulatory and clinical development functions in developing strategy and executing this strategy by means of effective applications for authorisation to conduct clinical trials.

Course Outline

Day 1

1. Developing a Clinical Regulatory Strategy
2. Scientific Advice
3. Regulatory Considerations for First-In-Man Clinical Trials
4. Workshop - Preparing a Clinical Regulatory Strategy

Course Description

The course covered aspects of regulatory affairs related to clinical development, from developing a regulatory strategy through to submission and maintenance of clinical trial applications in Europe and the US. 

Day 2

1. Clinical Trial Applications in the EU - Content and Process
2. US INDs - Content and Process
3. Maintenance of Clinical Trial Applications
4. Clinical Trial Supplies - Regulatory Considerations

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RRG, Innovation House
Albany Park, Camberley
Surrey. GU16 7PL

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