Course description

Regulatory Strategy for a New Active Substance: Global Clinical Development

This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of global clinical development. It will allow them to examine the regulatory requirements imposed on clinical development, the processes of preparing documentation for clinical study reports and regulatory overview/summary documents, and strategic considerations for the running of international clinical trial programmes. Lectures and workshops will cover the understanding and application of modern approaches and understanding of designing the clinical programme, different types of studies (pivotal studies, dose-finding, special studies) trial designs, statistical input (intention to treat, efficacy populations), pharmacoeconomics, clinical trial application strategy, special populations (paediatric, elderly, organ impairment) preclinical requirements, territories, (trial locations: diseases prevalence, patient populations, medical expertise) writing and evaluating clinical reports and summaries, risk management, and evaluating the data at the regulatory authorities, and achieving a Global Clinical Programme dossier.

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable the students to contextualise their understanding and knowledge.

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Suitability - Who should attend?

Suitable for

Students of the MSc programme
participants from the regulatory affairs industry who wish to develop their knowledge of the requirements for global clinical development
participants from allied industries who wish to have a comprehensive understanding of the subject

Outcome / Qualification etc.

Benefits to participants

This course will enable you to:

Possess a systematic understanding of knowledge and a critical awareness of the regulations and international directives pertaining to clinical development of a new medicine
Show a critical awareness of the clinical programme strategies which can be employed during development and registration of a new medicine of clinical programme strategy, and effective regulatory leadership throughout the clinical development and the registration of a new medicine
Display a comprehensive understanding of the EU Legislation on the different aspects of clinical development and of the procedures and regulatory requirements for clinical trial reports, clinical overview and summary documents for optimal product labelling
Evaluate methodologies and develop critique of the medical, statistical, economic and operational aspects of clinical trial programmes
Demonstrate the ability to critically analyse the legal documentation global operational clinical trial programme considerations of clinical research
Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data and communicate their conclusions clearly to specialist and non-specialist audiences
Critically appraise and evaluate global clinical research communications from regulatory bodies and research publications

Training Course Content

Lecture 1: Strategy for a Global Development
Lecture 2: The Clinical Trial Programme
Lecture 3: Overview of Requirements for Clinical Trials
Lecture 4: Ethnic Factors and Clinical Strategies for Non-ICH Markets
Lecture 5: The Statistical Input
Lecture 6 : Paediatrics and other Special Populations
Lecture 7: Unconventional Study Designs
Lecture 8: Philosophies and Assessment Techniques of the Regulatory Authorities
Lecture 9: Pharmacoeconomics Studies
Lecture 10: Clinical Study Reports – Strategic Importance
Lecture 11: Clinical Summary Documentation
Lecture 12: Pharmacovigilance Strategies
Lecture 13: Pharmacogenetics/Pharmacogenomics
Lecture 14: Common Faults in Clinical Registration Packages An agency view of clinical documentation