ÂÜÀòÉç

Phishing warning 01-May-2024
We are aware of phishing emails targeting speakers of events whose names appear on our events pages. If you are unsure if an email regarding event registration or accommodation has come from us please contact us and do not provide any credit card details or personal information.

Comparability Challenges: Regulatory and Scientific Issues in the Assessment of Biopharmaceuticals

3 - 4 February 2009, Arlington, VA, United States


Introduction
During the lifetime of all products, there is a need to make changes in production methods, the impact of which must be evaluated for quality purposes as well as for submission to regulatory authorities. This is especially important for biotechnology-derived products whose characteristics are closely related to the manufacturing process. The FDA requires information to establish comparability between current products and products following manufacturing changes. Depending on the change, in vitro comparisons, animal data, clinical data, or some combination of these areas, may be necessary.

FEATURED TOPICS
•Characterization of changes in cell lines, process scale, formulation/presentation and the comparative data necessary to support these changes
•Discussion of in vitro biochemical, preclinical (pharmacokinetics, pharmacodynamics, toxicology, immunogenicity), or clinical data needed for some changes and value of these data
•Case studies and the data requested by regulatory authorities.

Useful links

Venue
Sheraton National Hotel Arlington

Sheraton National Hotel Arlington, 900 South Orme Street, Arlington, VA, 22204, United States

Useful links

Organised by
Drug Information Association
Contact information
Marketing Manager
800 Enterprise Road, Suite 200, Horsham, PA, 19044, United States of America
+1.215.442.6100
Contact us by email

Search
 
 
Showing all upcoming events
Start Date
End Date
Location
Subject area
Event type

Advertisement
Spotlight


E-mail Enquiry
*
*
*
*