Startdate:
3 October 2013 - 4 October 2013

Purpose:
Pharmaceutical industries and small start-up biotechnology companies are under heavy pressure to develop new and effective drugs, and at the same time meet the financial expectations. In order to meet these expectations, including a faster and more efficient drug development, regulatory affairs experts must take an active and crucial part in the entire development process.

Regulatory courses normally focus on laws, guidelines, and directives, but offer little knowledge on the role of regulatory experts in project teams. Consequently, this module will not focus on guidelines, but look behind them, and provide the students with knowledge of the background and thinking behind the key factors of global regulatory strategies and the preceding considerations. The course offers a number of internationally experienced lecturers, who will guide the students through important key issues such as:

• Regulatory Affairs Involvement in Product Development
• Regulatory Strategies
• Consultation with Authorities throughout Development
• Regulatory Intelligence
• The Development of a Target Label
• Regulatory Planning in the Submission Step
• Intellectual Property Rights - Data Exclusivity
• Pricing and Reimbursement Negotiations

At this module you will really get behind regulatory decisions and strategies. Everyone working within the Regulatory Affairs Area knows how important and how much more effective you will be able to work if you have an in-depth understanding and knowledge of how and why they are made. Every regulatory affairs employee will be able to benefit from this knowledge and take an active and more efficient part in future decision-making processes. 

By the end of this module, the student should be able to:

- understand the purpose of and processes in developing a regulatory strategy for products in various stages of the product life cycle

- analyse strengths and weaknesses of a product in order to develop regulatory strategies and target product profiles

- use best practice, when communicating a regulatory strategy to the company project team or top management, and to operate in a highly dynamic and    constantly changing environment, where internal as well as external business partners and authorities need to understand the rationale of the product development

Content:
Areas that among others will be covered in this two-day intensive course are: 

•  Introduction to Regulatory Strategy
•  Regulatory Strategies and Strategic Considerations in General
•  Regulatory Strategies and Strategic Considerations in the USA
•  Regulatory Intelligence
•  Regulatory Strategies and Strategic Considerations in the EU
•  Life Cycle Management Strategies
•  Regulatory Strategy Plan – case story
•  Regulatory Strategies and Strategic Considerations in Japan
•  Exclusivity
•  Target Labelling – Key Elements, Sources of Information and the Studies
•  The Concept of Target Labeling for a New Molecular Entity
•  The Studies Supporting the Target Labeling
•  Pharmacoeconomics

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 (not included in the course fee):
If you need hotel accommodation, we recommend Hotel Twentyseven where you will get a discounted price, but you are of course welcome to choose any other hotel that you might prefer, but the shuttle bus will go from Hotel Twentyseven to Medicademy in the morning and from Medicademy to Hotel Twentyseven in the afternoon. There are no hotels very close to the Medicademy facilities which is why we have chosen this hotel, very centrally located, situated in downtown Copenhagen and close to the central train station of Copenhagen (Københavns Hovedbanegård), to where the airport train goes.