MSc in Regulatory Affairs: Module 4 – Regulatory Strategy for a New Active Substance: Global Clinical Development

Aim

The purpose of this Module is to enable students to provide effective regulatory leadership within their organisations throughout the clinical development and the registration of a new medicine.

Learning outcomes

• Students will differentiate the different types of clinical study design and identify the pros and cons of each within the context of global regulatory requirements.
• Students will evaluate the medical, statistical, economic and operational principles underpinning the successful conduct of a clinical trial programme.
• Students will identify the activities required to ensure that data suitable for a product registration are derived from the clinical studies programme.
• Students will determine the strategic role of clinical study reports and summaries in obtaining an optimal product label.
• Students will understand the Regulatory Authorities' views of the clinical dossier.

Outline of Module topics

• Designing the clinical programme: strategy for global development; the clinical trial programme; core protocol, pivotal studies, dose-finding, special studies, trial designs, patient numbers; statistical input (intention to treat, efficacy populations); pharmacoeconomics, pharmacogenomics
• Getting the trial underway: Clinical Trial Application strategy, special populations (paediatric, elderly, organ impairment), preclinical requirements, territories (trial locations: disease prevalence, patient populations, medical expertise), clinical trial registries
• Keeping the programme going: timescales, project management and costs
• Heath Authorities – Your Partner in Drug Development: understanding and interpreting regulatory guidelines for a global drug development, seeking and implementing scientific advice
• Ensuring the right outcome: writing and evaluating clinical reports and summaries, risk/benefit evaluation, risk management, the target product profile and optimal product labelling
• Evaluating the data at the Regulatory Authorities: philosophies and assessment techniques, common faults in clinical registration packages, achieving a Global Clinical Programme and dossier

Links with other modules

• Module 5 complements this Module, covering the practical regulatory issues associated with running clinical studies.

ECTS credits

"Whilst the TOPRA MSc in Regulatory Affairs is based in the UK it has students globally, and covers regulations globally, too. It is also part of the "European Credit Transfer and Accumulation System"(ECTS). This means that if you attend its modules then you can get credits against other degree courses across Europe should you wish to transfer the learning which you have accumulated, and vice versa where you have done studies of part of an MSC course in another EC country. This has great advantages of mobility and flexibility.

For more information contact the TOPRA office or go to www.topra.org/msc/ects.