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

Turkish Cargo keeps growing steadily.

According to the international air cargo information provider WACD's September data, the global air cargo brand Turkish Cargo, which serves 126 countries of the world, grew significantly by achieving a tonnage increase of 8.8 percent in a sector wherein the global air cargo market shrank by -5.4 percent.
More info >>


White Papers

Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.

Medpace

Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
More info >>


Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India forhigh quality, low   cost pharma solutions, CPhI & P-MEC Indiais the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India’s pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement