2011-Dec-09

Successful INFOTEHNA's XEVPRM WORKSHOP

XEVPRM WORKSHOP was organized by INFOTEHNA on 8 December in Zagreb, capital of Croatia. 34 delegates from 9 pharmaceutical companies attended the event dedicated to new regulation requirements issued by the European Medicines Agency.

The Regulation (EC) No 726/2004 regards Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorisation Holders to the European Medicines Agency. It requires that by 2 July, 2012, information on medicinal products for human use authorized or registered in the Union is submitted electronically.

Attendees have learned about content, essence, specific requirements and efficient tools they can use to be compliant with the decree once it will come into force. The occasion was perfect opportunity for exchange of questions and opinions about the topic.

 

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