Module B: The Quality & Pre-clinical part of the dossier

The second module discusses two important elements of the Common Technical Document (CTD): quality and non-clinical studies. Good manufacturing and distribution practices (GMP and GDP), pharmacology, toxicology and quality by design will be some of the topics discussed here.

Learning objectives

After this module you will be able to:

  • Outline GMP and GDP requirements, with an understanding of the importance of the European Falsified Medicines Directive and how to avoid inspection failure.
  • Outline the guidelines of the CMC/Quality part of the dossier.
  • Explain the concept of ‘quality by design’ as it relates to quality target product profiles, critical quality attributes, critical process parameters and risk assessments.
  • Discuss topics related to biologicals including biosimilars such as specific regulatory requirements for the dossier, the manufacturing process and the risks at each stage of the process.
  • Discuss pharmacology and toxicology in the context of the preclinical development of a pharmaceutical product/biological product; relevant regulatory requirements; and also aspects of preclinical safety sciences, such as safety biomarkers.
  • Explain the relationship between pharmacokinetics and pharmacodynamics and understand the fundamentals of (pre)clinical pharmacokinetics & metabolism studies and the legal framework/guidelines involved.
  • Explain the relationship between pharmacology, clinical trial design, regulatory strategy and critical success factors for preclinical medicines development.
  • Explain the role of preclinical safety studies in medicines development, and registration in Europe, and the scope, type and timing of studies needed.
  • Discuss scientific and regulatory topics of interest, such as single and repeat dose toxicity; establishing first human dose; toxicity to the immune system; genotoxicity carcinogenicity testing; pharmaco-toxicokinetics; and impurities.
  • Explain the importance of the preclinical dossier with regard to the pediatric development of a pharmaceutical product.
  • Outline the regulatory requirements for bioavailability and bioequivalence in the development of a pharmaceutical product, including generics, and how specific issues such as food interaction should be addressed.
  • Explain how the non-clinical dossier is translated in product information for a medicine, and used in a medicine’s benefit-risk assessment.