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EMA to go extra mile to facilitate joint safety study for valproate

 
• By Vibha Sharma

In the course of its mandate to help companies carry out joint post-authorization safety studies under the EU pharmacovigilance legislation, the European Medicines Agency is planning to organize a teleconference/webinar for a new study concerning the anti-epileptic drug valproate so that interested companies may be introduced to each other and have the opportunity to interact and raise questions.

In the course of its mandate to help companies carry out joint post-authorization safety studies under the EU pharmacovigilance legislation, the European Medicines Agency is planning to organize a teleconference/webinar for a new study concerning the anti-epileptic drug valproate so that interested companies may be introduced to each other and have the opportunity to interact and raise questions.

The EMA has already ordered several PASS under the pharmacovigilance legislation and has taken steps to ensure these studies are undertaken jointly by concerned marketing authorization holders. However, this is the first time the agency will be organizing a teleconference/webinar for this purpose, an EMA spokesperson told Scrip Regulatory Affairs

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