CRED: Clinical Development

Brochure

Early to Late Stage Clinical Development

Aims of the course

This 2 day workshop will provide an overview with practical advice from regulators and industry on the process of designing and conducting clinical trials from phase I (volunteers) through phases II, III and even clinical trials considerations beyond drug marketing approval. Case studies are used to support learnings from the formal presentations and to draw upon experiences of those attending. The aim of this practical workshop is to enable all those involved in medicines development to gain an appreciation of the points to consider when designing a clinical development programme to support a marketing application and also that clinical development extends beyond the marketing application.

Course content:

• An overview of pharmacokinetic and healthy volunteer studies including use of volunteers or patients, definition of the pharmacokinetic profile, the need for bioequivalence data and studies in subgroups
• An overview of clinical pharmacodynamics including mechanism of action, onset of action and duration of effect, design considerations to maximise information obtained and determination of tolerability
• An insight into the specifics of clinical trial design at the different phases, including objectives of study, inclusion/exclusion criteria, choice of endpoints and comparators, and duration of trials. The impact of paediatric legislation.
• Statistical issues including the importance of good statistical planning and sample size, basic statistical techniques and choices
• Drug safety issues including the overall size of the safety database, pharmacological class effects, relevance of findings in animals, and
• Studies beyond marketing filing.

Who should attend

• The less experienced regulatory professional who requires comprehensive information on this subject
• The experienced professional who is a newcomer to this subject
• Anyone who wishes to update their knowledge on this subject.
• Persons from regulatory, medical, clinical and safety involved in phase I, II, III and IV trials

Speakers:

• John Warren, Medicines and Health Care products Regulatory Agency (MHRA), UK
• Basil Houdali, Lilly
• Steve Pinder, Envestia Limited
• Frits Lekkerkerker, NDA Regulatory Science Ltd

Plus other invited speakers