THE CLINICAL
OVERVIEW AND
CLINICAL SUMMARY:

THE CLINICAL OVERVIEW AND CLINICAL SUMMARY:

THE CLINICAL
OVERVIEW AND
CLINICAL SUMMARY:

CREATING AN EFFECTIVE MARKETING AUTHORISATION
APPLICATION

CREATING AN EFFECTIVE MARKETING AUTHORISATION APPLICATION

CREATING AN EFFECTIVE MARKETING AUTHORISATION
APPLICATION

PHARMACEUTICAL

Conference Date: 14 Oct 2008
Conference Ref: A10-1008
Fee: £540 + VAT
Venue: The Rembrandt Hotel, London

The Common Technical Document Guideline is now the obligatory format in the EU, US, Japan and many territories worldwide including Canada and Switzerland, for registration applications. This meeting will present the regulatory guidelines and requirements, discuss current approaches to the content and preparation of the Clinical Overview and Clinical Summaries (module 2) and provide an update on the latest information and potential future developments.

24 * PHARMACOVIGILANCE ASPECTS OF LICENSING AGREEMENTS
* MULTI-TASKING AND MANAGING MANAGERS

25 * A REGULATORY UPDATE ON ANIMAL FEED ADDITIVES

26 * MANAGING EU FEED ADDITIVE PROJECTS ~ FROM CRADLE TO CRADLE
* BIOSAFETY TESTING

27 * THE EU PHARMACEUTICAL DOSSIER
* OBTAINING AND ENFORCING PATENT RIGHTS IN ASIAN COUNTRIES
* THE TRADEMARK ADMINISTRATOR
* VETERINARY STATISTICS

28 * THE PATENT ADMINISTRATOR