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The Impact of Regulatory Affairs on Chemistry, Manufacturing & Controls (CMC)

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Generics are becoming increasingly central in both industrialised countries and in developing countries. The overall requirements for generics will be detailed including problems in relation to generic substitution and falsified medicines.

The course will consider the important aspects for Active Pharmaceutical Ingredients (APIs), such as requirements to the production and supplier qualification and certification. The implementation of ICH Q11 will be discussed.

Bioequivalence testing is an integral part of the development both of new medicinal products and of generics. Revised EU guidance has been developed and the impact of the new guidance will be thoroughly discussed.

Globalisation is an important element in the production of drug substances and drug products to be licensed and marketed in Europe. This course will focus on three essential topics which are particularly influenced by production in a global environment.

The course will be taught with a combination of presentations by the faculty and work in small groups assisted by faculty members. A significant amount of time will be devoted to working on case studies. Results from the working groups will be presented to the full audience.


API production/API supplier qualification and certification

ICH Q11/EDQM CEP/WHO pre-qualification

  • Selecting and justification for a starting material
  • Supply chain traceability
  • Responsibility of the API manufacturer
  • Responsibility of the pharmaceutical company
  • Impurities
  • Quality by Design (QbD)
  • Critical Quality Attributes (CQA’s)
  • API inspection/supplier audits
  • Lifecycle management/variations
  • Value and role of certification (EU/WHO)

Bioequivalence testing

  • EU new guidance
    • Basic principles
    • Design of studies
    • Pharmacokinetic parameters
    • Analytical considerations
    • Acceptance criteria
    • Biopharmaceutical Classification System (BCS)
    • Biowaivers – how to avoid the need for in-vivo studies
  • Relations and responsibilities of CRO/ pharmaceutical company
  • Supplier audits
  • Global bioequivalence requirements: WHO/EU/US
  • Lifecycle management/variations

Generic medicines

  • Overview of global requirements: WHO/EU/US
    • API requirements; known versus new substances
    • Pharmaceutical development
    • Bioavailability/bioequivalence
    • QbD
  • Lifecycle management/variations
  • Role of generic medicines in industrialised countries versus developing countries
  • Generic substitution
  • Falsified medicines
Contact your regional office for future dates and locations.
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