Regulatory Introduction to the Licensing of Biological Medicinal Products (PQMT_bio)
|Event Date/Time: Mar 26, 2010||End Date/Time: Mar 26, 2010|
WHAT ARE BIOLOGICAL MEDICINAL PRODUCTS AND WHY ARE THEY DIFFERENT?
REGULATION OF BIOLOGICALS: ROLE OF WHO AND THE EU
â€˜CONVENTIONALâ€™ BIOLOGICAL PRODUCTS
RECOMBINANT PRODUCTS: PROTEINS AND GLYCOPROTEINS
CHALLENGES OF BIOLOGICAL CONTAMINATION
BLOOD AND BLOOD COMPONENTS
WHERE DO WE GO FROM HERE?
GENERAL QUESTIONS, CONCLUDING REMARKS + IMMEDIATE ORAL FEED-BACK
This Course has been prepared in response to requests from our previous delegates for an introductory overview of the issues that distinguish biological medicinal products from synthetic medicines. Attention will be given to the regulatory background for the many different classes of â€˜biologicalsâ€™, â€˜immunologicalsâ€™, products derived from blood, products (e.g. vaccines, antibodies, biogenerics) made using sophisticated (recombinant) biological culture or cloning systems. Special and varied issues concerning possible contamination and necessary purification activities will be discussed.
The course builds from first principles and will illustrate issues that have to be addressed in supporting documentation for Marketing Authorisation Applications (MAAs).
Delegates are likely to be from the pharmaceutical and biotechnology industries.
The course is suitable for people new or relatively new to regulatory affairs, particularly people transferring within a company into product registration work in a Biologicals area.
This course and our CTD Module 3 course may be complementary and useful to some delegates. The next presentations of these courses are consecutive and will be on 24-25-26 March 2010 (for more details of the â€œCTD Module 3â€ course click here)
The trainers will be Professor Derek Calam and Dr Mike Robertson who have many years of experience within UK, European and WHO institutions and have reviewed numerous MAAs.