PharmaQMtraining.eu
Course Outline
 
   
A one-day course
Regulatory Introduction to the Licensing of Biological Medicinal Products
The Course topics include
(this is not necessarily the running order)

TIMETABLE

25 March
Hotel check-in
from 14.00h
26 March
Registration
08.30h
Course Begins
09.00h
Ends
17.30h

INTRODUCTION AND WELCOME
WHAT ARE BIOLOGICAL MEDICINAL PRODUCTS AND WHY ARE THEY DIFFERENT?
REGULATION OF BIOLOGICALS: ROLE OF WHO AND THE EU
‘CONVENTIONAL’ BIOLOGICAL PRODUCTS
RECOMBINANT PRODUCTS: PROTEINS AND GLYCOPROTEINS
MONOCLONAL ANTIBODIES
CHALLENGES OF BIOLOGICAL CONTAMINATION
BLOOD AND BLOOD COMPONENTS
VACCINES
WHERE DO WE GO FROM HERE?
GENERAL QUESTIONS, CONCLUDING REMARKS + IMMEDIATE ORAL FEED-BACK Previous page

EXCEPTIONAL VALUE: £525.00 + 17.5% VAT
Your delegate package includes training from experts, training materials, certificate of attendance, daytime food and drinks and one night’s accommodation*
* extra night(s) bookable if required, subject to availability


MORE ABOUT THE BACKGROUND TO THIS COURSE
AND WHO SHOULD ATTEND

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 ‘biologicals’, ‘immunologicals’, 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.


ADDITIONAL INFORMATION

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 “CTD Module 3” course click here)


COURSE LEADERS

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.

Please sign up for future announcements

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