A Short Course on Regulatory Affairs with emphasis on the Biological/Biotechnological Drug Substance (Biologicals_June2010)

Venue: Legacy Falcon Hotel

Location: Stratford-Upon-Avon, United Kingdom

Event Date/Time: Jun 22, 2010 End Date/Time: Jun 23, 2010
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Description

AGENDA
(Not the precise running order)

INTRODUCTION AND WELCOME

* WHAT ARE BIOLOGICAL MEDICINAL PRODUCTS?
Lay terms, legal terms, legislation, guidelines, pharmacopoeias

BIOLOGICAL MACROMOLECULES AND PRINCIPLES OF THEIR QUALITY CONTROL

* SCIENTIFIC ISSUES
History and product evolution, chemical and structural types, manufacturing approaches, analytical demands, medicinal product diversity
* EUROPEAN UNION (EU) REGULATORY PROCEDURES
Legal requirements and interpretation through guidelines and other publications from the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the International Conference on Harmonisation (ICH)
* WHO INVOLVEMENT
Official nomenclature, establishment of reference standards and their provision and correct use in bioassays and immunoassays, for expression of activity and other purposes

PREPARING CONTENT FOR THE QUALITY MODULES 2.3 and 3 OF THE COMMON TECHNICAL DOCUMENT (CTD)

* DRUG SUBSTANCE AND DRUG PRODUCT Key issues about the Quality Overall Summary and the CTD ‘Quality’ Body of Data (Module 3)
* Source of materials and establishment of cell banks
* Culture and fermentation
* Characterisation of recombinant and other materials
* Analytical issues and specifications
* Biological and immunological issues for characterisation and control
* Consequences of a manufacturing change and understanding about comparability
* Stability issues: Special considerations for biologicals compared to ‘small molecules’ drug substances, choice of and influence of excipients including biological excipients, maintenance of molecular structure, compatibility
* Numerous examples including deficiencies

PREPARING CONTENT FOR THE NON-CLINICAL MODULES 2.4 and 4 OF THE CTD

* HOW DO BIOLOGICS DIFFER FROM CONVENTIONAL SMALL-MOLECULE DRUGS?
Small-molecule drugs versus biotechnology products, nonclinical testing guidelines (ICH M3/S6), manufacturing and specification issues, trans-species conservation and choice of pharmacologically relevant species, dealing with main types of pharmtox studies, recent regulatory developments

BIOLOGICAL CONTAMINATION

* MAJOR POTENTIAL PROBLEMS TSE, viruses, bacteria and mycoplasma in source materials and those used in production (culture media)

BIOSIMILARS

* EXAMINING NONCLINICAL, CLINICAL AND QUALITY ASPECTS Highly similar objectives, bridging nonclinical and clinical studies, establishing safety and efficacy with multi- disciplinary approaches

RECENT AND POSSIBLE FUTURE DEVELOPMENTS

* SPECIFIC ISSUES FOR SPECIFIC BIOLOGICALS AND CLASSES OF BIOLOGICALS What’s new and where might we be heading?

ADDITIONALLY THERE WILL BE ONE OR POSSIBLY TWO GROUP INTERACTIVE CASE STUDIES

Venue

Stratford-Upon-Avon, UK
United Kingdom
MORE INFO ON THIS VENUE

Additional Information

Bookings on http://www.pharmaqmtraining.eu/booking_form.html

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