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


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

Who should attend?

Representatives from governmental institutions, pharmaceutical industry including, but not limited to:

  • Regulatory affairs specialists and managers
  • Development managers and experts
  • Quality assurance managers and experts
  • Assessors in regulatory authorities

Level: Junior to intermediate

Learning objectives

At the conclusion of this course, participants should be able to:

  • Differentiate the obligations of the pharmaceutical company from those of the API manufacturer
  • Identify the key elements of the drug substance part of a registrations dossier including the value of certification schemes
  • Discuss the influence of the concepts introduced by QbD
  • Recognise the elements and the effects of the revised EU guidance on bioequivalence
  • Identify particularities of the EU bioequivalence guidance as compared to current US-FDA, and WHO recommendations.
  • Discuss the influence of formulation changes on the need for new bioequivalence testing
  • Identify the differences and similarities in requirements to the quality dossier for generics compared to new drug products
  • Discuss the influence on generics documentation form recent new ICH guidelines, Q9-Q11

Contact us

DIA Europe


4002 BASEL



TEL.: +41 61 225 51 51

FAX:  +41 61 225 51 52