Overview
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.
KEY TOPICS
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
- 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
Generic medicines
- API requirements; known versus new substances
- Pharmaceutical development
- Bioavailability/bioequivalence
- QbD
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