MSc in Regulatory Affairs: Module 3 Regulatory Requirements for a New Chemical Active Substance: Chemistry and Pharmacy

Aim

The purpose of this module is to provide students with an understanding of the chemistry and pharmacy development programme to enable them to provide effective advice on the suitability of the chemistry and pharmacy programmes from a regulatory perspective.

Learning outcomes

• Students will be able to describe the drug substance requirements: nomenclature, description, synthesis, development chemistry, quality control during synthesis.
• Students will understand the drug product requirements: formulation and pharmaceutical development, dissolution testing, bioequivalence of different dosage forms used in clinical trials, manufacture, GMP, process validation, specifications and routine tests, packaging, stability.
• Students will be able to understand the importance of analytical validation.
• Students will gain an insight into the chemical and pharmaceutical aspects of clinical trial and marketing authorisation applications.
• Students will be able to describe the formatting of the chemistry and pharmacy documentation and how ICH will affect this formatting globally.
• Students will gain an insight into the Regulatory Authorities’ views of the chemistry and pharmacy dossier.

Course content includes

• The role of chemistry and pharmacy in the overall drug development programme
• The chemistry and pharmacy dossier: format and structure in EU and US, Module 3 of the Common Technical Document
• Nomenclature and characterisation of active ingredients
• Analytical methods and validation
• Manufacture and in-process controls of bulk pharmaceutical chemicals
• Development pharmaceutics and manufacture of the drug product
• Relevance of bioequivalence and bioavailability in formulation development
• Dosage form:quality control during manufacture
• Developing specifications: drug substance and drug product
• Stability: drug substance and drug product
• Chemistry and pharmacy section of clinical trial applications
• Good Manufacturing Practice: drug substance and drug product
• The role of the Qualified Person
• Pharmaceutical Expert Reports and the impact of the Common Technical Document
• Maintaining the Marketing Authorisation/ NDA: EU variations
• View of Regulatory Authorities: common deficiencies and current major concerns programmes from a regulatory perspective.

Links with other Modules

• Module 2 covers preclinical aspects of the regulatory strategy for a New Active Substance.
• Module 8 covers data requirements for abridged applications and specialist products.
• Module 11 covers specific requirements for New Drug Applications in the US.