is being presented by Dr. Ulrich Granzer, President, Granzer
Regulatory Consulting & Services and airs on Tuesday, May 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The EU parliament and the EU Council have issued a new pharmacovigilance
regulation, which will come into force in July. The legislation defines new and
additional tasks and responsibilities for the Coordination Group, defines a new
“urgent union procedure” for pharmacovigilance, and also provides a definition
for post authorization safety and efficacy studies and how these new tasks are
to be performed. For this particular set of tasks a new body is being
established, called PRAC, which will perform safety evaluations. Opinions of the
PRAC will then be adopted by the EMA or, in the case of older or national
registrations, the Coordination Group for the Decentralized and the Mutual
recognition procedure, the CMDh. This new system will be in charge of all
critical pharmacovigilance items and issues.
In this audio conference presentation, our speaker discusses these new
changes to the EU pharmacovigilance rules, as well as potential critical issues
arising from the EU’s complexity and decision-making process.
