Regulatory challenges for 2012 and their impact on marketing authorisation

INTERNATIONAL SEMINAR – 23 February 2012 in Ahmedabad

Come join us in Ahmedabad and expand your expertise pool!

• REGULATORY CHALLENGES FOR 2012: OVERVIEW OF LATEST CHANGES IN THE EUROPEAN REGULATORY PROCEDURES
• VARIATIONS REGULATION – THE NEW ELEMENTS
• EUDRAVIGILANCE CHANGES: IMPLEMENTATION OF ELECTRONIC SUBMISSION OF MEDICINAL PRODUCT INFORMATION IN THE EU (ARTICLE 57(2) REQUIREMENTS OF THE NEW PHARMACOVIGILANCE LEGISLATION)
• ONGOING IMPLEMENTATION OF THE NEW EU PHARMACOVIGILANCE LEGISLATION BY THE EUROPEAN MEDICINES AGENCY, THE MEMBER STATES AND THE GENERIC PHARMACEUTICAL INDUSTRY.

This training course will provide a limited pool of attendees an excellent overview of latest changes in the European Regulatory procedures.

The course will cover the evolution of the registration systems available for approval of products in the European Union, together with major changes in New Medicines Legislation.

The very important changes in New Medicine Legislation concerning regulatory procedures, access to Centralised and Mutual Recognition Procedures, reduction in Regulatory Data protection will be described in detail.

Detailed review will be offered on the changed Centralised and Mutual Recognition Procedures and New Decentralised Procedure with discussion of practical examples of product types suitable for each procedure.

Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.

In short, this will be a fantastic opportunity to meet the experts that you need today and to tap into the network of experts that you more than likely will need tomorrow.

Or by fax or you can also call your sales representative on +420 22 491 00 00 or + 91 79 4024 1999

Book a course now and save! Early bird rate of 7000 INR applies to registration completed by December 1st 2011.

We hope that this course is of interest to you, and look forward to welcoming you to an ELC GROUP training course soon.