Filing Variations

January 2010 sees the introduction of revised legislation for Variations to Marketing Authorisations. Initially applying to Authorisations issued through the Mutual Recognition, Centralised or Decentralised procedures, by January 2011 it should be clear when and how they will also apply to Nationally approved products.

The changes are the result of extensive consultation by the Commission in response to the ‘Better Regulation’ initiative, and introduce revised procedures and new Guidelines.

But how will they affect you? Need answers?

This 2-day practical training course will provide you with an interactive environment to address the many implementation issues of filing Variations. The course is packed with exercises and case studies to meet your regulatory goals and tackle your everyday challenges.

"Filing Variations" course has been developed following extensive research with the industry, You will gain a full update on the very latest changes to the variations guidelines in the EU. Featuring a blend of interactive learning tools, including case studies, group discussions, scenarios, simulations, practical exercises and knowledge assessments; this courses focus on practical techniques.