This course is also available to attend in-person
When: 9-10 November 2027
Where: Online
Time: 09:20 GMT
CPD: 15.5 CPD hours upon successful completion
Who should attend
This course is ideal for:
- Less experienced regulatory professional seeking a comprehensive understanding of clinical development
- Experienced professionals who are new to this area or wish to refresh their knowledge
- Individuals from regulatory, medical, clinical and safety functions involved in phase I, II, III and IV trials
What you'll learn
By completing this course, you will be able to:
- Optimise a clinical development programme to support a successful marketing application
- Design clinical trials that demonstrate proof of efficacy
- Apply key principles of clinical pharmacokinetics and pharmacodynamics to inform dose selection and study design
- Select and justify optimal study designs across different stages of clinical development
- Understand the role and requirements of Paediatric Investigation Plans
Course overview
This course provides an overview from regulators and industry on the process of designing and conducting clinical trials during phases I, II and III. It covers the main considerations for devising a clinical development programme, including clinical pharmacokinetics and pharmacodynamics, study design, paediatric requirements and safety, to support a marketing application and beyond.
Presenters
The expert presenters for this course will be announced soon.
Pricing
TOPRA member: £1,250 + VAT
Non-member: £1,750 + VAT
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Members working for regulatory or government agencies, academic institutions, charities, patient groups, emerging markets and MSEs can access further discounted rates. Please email
meetings@topra.org before booking.
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Terms and conditions
By booking a place on this course you are agreeing to the Training Terms and Conditions.