Filing Variations

PTIs Filing Variations course has been developed following extensive research with the industry.

Pharmaceuticals/Drug Discovery, Medical & Health Care

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January 2010 saw the introduction of revised legislation for Variations to Marketing Authorisations.

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 do they affect you? Need answers?

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

What will you learn?
- Manage the practical hurdles of submitting your variations on time and with the right supporting data
- Collect and present complete information on your variations
- Tackle the challenges of type II variations under the MRP

Book before the 20th February 2014: £1395 + 19% VAT = £1660.05
Book after the 20th February 2014: £1495 + 19% VAT = £1779.05