spacer
home > white papers > Pharmacovigilance and Risk Management Information in Centralised Applications in the EU - United BioSource Corporation (UBC)
WHITE PAPERS
logo_United_Bio2.JPG

United BioSource Corporation (UBC)

phone +44 (0) 208.834.0100
email contact@ubc.com
web http://www.ubc.com/europe
email 26-28 Hammersmith Grove London, W6 7HA, United Kingdom

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
Pharmacovigilance and Risk Management Information in Centralised Applications in the EU
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

IONTAS to Generate Antibodies using Mammalian Display Technology for a Global Biopharma

Cambridge, UK, 22 January 2018: IONTAS Limited (IONTAS), a leader in the discovery and optimisation of fully human antibodies, announced today that it has signed an agreement with Sanofi to discover antibodies using IONTAS’ proprietary Mammalian Display Technology.
More info >>


White Papers

Characterisation of Biopharmaceutical Proteins

Reading Scientific Services Ltd (RSSL)

Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. Consequently, in line with regulatory guidance, there will be a commensurate need to provide full characterisation of such biopharmaceuticals. The purpose of this article is to describe the array of the more common techniques used in biopharmaceutical characterisation (typically of protein or polypeptide). For full characterisation of a protein, the protein�s primary, secondary and tertiary structure as well as its physiochemical properties should be assessed.
More info >>


Industry Events

RDD Asia 2018

14-15 November 2018, Grand Hyatt Kochi, Kerala, India

A must-attend meeting for pulmonary and nasal researchers, inhaled product developers and vendors active in this important pharmaceutical niche.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement