The Imperial Riding School, Renaissance Hotel , Vienna, Austria
May 8 2012 8:00AM - May 10 2012 5:00PM
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. Drug substances, Active Pharmaceutical Ingredients (APIs), produced in the Far East are being used more and more often as ingredients in products for the European market. The course will consider the important aspects of this situation such as requirements to the production and supplier qualification and certification. Bioequivalence testing is an integral part of the development of both new medicinal products and generics. Revised EU guidance has been developed and the impact of the new guidance will be thoroughly discussed. Generics are becoming increasingly central in both industrial countries and developing countries. The overall requirements to generics will be detailed including problems in relation to generic substitution and falsified medicines. 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 group work will be presented for the full audience on an ongoing basis. KEY TOPICS API production/API supplier qualification and certification ICH Q11/EDQM CEP/WHO prequalification - Selecting a starting material and justification
- 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
o Basic principles
o Design of studies
o PK parameters
o Analytical considerations
o Acceptance criteria
o Biopharmaceutical Classification System (BCS)
o Biowaivers – how to avoid the need for in-vivo studies - Relations and responsibilities CRO/pharmaceutical company
- Supplier audits
- Global bioequivalence requirements: WHO/EU/US
- Lifecycle management/variations
Generic medicines - Overview of global requirements: WHO/EU/US
o API requirements, known versus new substances
o Pharmaceutical development
o Bioavailability/bioequivalence
o QbD - Lifecycle management/variations
- Role of generic medicines in industrial countries versus developing countries
- Generic substitution
- Falsified medicines
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
Event Code:
12579
|