Risk Minimization Strategies in Europe Require Customized Approach

UBC is a leader in creating customized risk minimization strategies

Risk Minimization Strategies in Europe Require Customized Approach

Pharmaceutical manufacturers understand that systems supporting approval and marketing for their products must be designed and implemented with a global outlook.   That’s easier said than done, taking into account the variety of regulatory bodies and requirements. 
Let’s begin by considering the pharma regulatory body in the United States.  As an agency of the US Department of Health and Human Services, the Food and Drug Administration (FDA) is responsible for protecting and promoting public health and includes regulation of pharmaceutical drugs.   Every person in the US, no matter where they live, is protected by this single agency. 

Now consider this:  the European Union (EU) is made up of 28 countries, spanning 4 million kilometers and has 503 million inhabitants (the world’s third largest population after China & India), speaking 24 official languages.  Each of these countries has its own regulatory agency responsible for drug and product safety.  And, within each of these countries, there are variations in regulations, clinical practice, and healthcare systems.  

As a leader in risk management and risk minimization, UBC has the experience and industry knowledge to guide manufacturers through these regulatory systems.  UBC is included in the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP ) Resources Database.   This database is an electronic index of available EU research organizations and data sources. Researchers and study sponsors seeking to identify organizations and data sets for conducting pharmacoepidemiology and pharmacovigilance studies in Europe rely on this database as a source of expertise.  UBC understands the importance of the ENCePP and the standards and guidance it provides the industry.

UBC also understands what it takes to successfully implement an EU Risk Minimization Plan in a Heterogeneous Europe.

If you’d like to learn more, join us when Janine Collins, M.D., Senior Director, European Risk Management, presents a webcast:  Strategies for Implementing Risk Minimization in Europe,  July 17, 9 a.m. EDT.   Register to attend the live webcast or to receive a reminder when the event is archived and available for on-demand viewing.