Startdate:
24 April 2012 - 27 April 2012

Purpose:
This module provides the students with an excellent opportunity to gain an overview of the regulatory aspects of global clinical development processes and the documentation needed for the clinical sections of CTD (Modules 2 and 5). Clinical sections are especially important, when completing a marketing authorisation of a new product or product labelling and in meeting the needs of patients and the marketing of the product.

The module is targeted at regulatory employees, who wish to gain a better understanding of the interrelationships and complexities in clinical development and the current regulatory requirements for developing a new treatment. Further, it provides clinical development staff with the opportunity to gain a better understanding of the relation between regulatory and clinical strategies and of the documents that must be prepared prior to regulatory approval.

By the end of this module, the student should be able to:
- understand the regulatory requirements for obtaining a global marketing authorisation for a new treatment, including pharmacological testing, exploratory and confirmatory investigations, and commitments to be completed post-marketing

- create, analyse and evaluate a regulatory strategy plan for the clinical development of a new drug

- familiarise with the principles of clinical development from phase I to IV

- learn how to create competitive product information by optimising the clinical development plan and supporting the desired labelling 

Content:

• How do we know that we are doing the right studies to satisfactorily demonstrate the efficacy and safety of the new treatment?
• Will we get product labelling that meets marketing’s needs?
• Do we have enough patients in our development program?
• Can we speed up the development process and the regulatory review?
• Can the drug development plans support global marketing also through life cycle management?
• How is clinical risk assessment handled during development and the pharmacovigilance process?
   

Prerequisites:
In order to secure the professional level of the education. The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications. Please note that applications will be considered in order of receipt.

Literature:
A list of recommended literature will be send to the participants approx. 4 weeks prior to the start of the module.
The list will be divided into mandatory and optional reading. The mandatory references is part of the examination syllabus.
The participants are expected to study and be familiar with the mandatory references in advance of the module.

Accomodation:
Hotel Twentyseven
Hotel Twentyseven is located in the heart of Copenhagen, close to the Town Hall Square, the Tivoli Gardens, and Copenhagen Central Station, and airport trains, S-trains, regional trains, and busses leave from the sta­tion regularly. Hotel Twentyseven has a special atmosphere based on unique experiences, living design, seductive comfort, hospitality, and an uncomplicated life. All the 200 rooms in the hotel have been designed in the well-known Scandinavian design tradition by leading Danish designers & architects. www.hotel27.dk
Fixed prices – breakfast included: Small single room - DKK 930 (approx. EUR 125), Double room for 1 person – DKK 1,080 (approx. EUR 145)