Startdate:
29 February 2012 - 2 March 2012

Purpose:
To provide the students with a comprehensive overview of the requirements and critical issues of non-clinical studies and at the same time support clinical development, and provide them with an overview of how to build up a Common Technical Document of the non-clinical part of a

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

- understand the purpose of each category of the non-clinical safety studies needed to support clinical development of pharmaceuticals, and understand how to build up the non-clinical part of a registration dossier

- analyse non-clinical requirements for specific types of medicine, clinical indications, and implications in relation to the composition and conduct of the non-clinical safety study programme

- use best practices when interacting with non-clinical specialists as well as with clinicians, CMC specialists, and the regulatory agencies in order to ensure that non-clinical safety information is generated, interpreted and communicated correctly to the benefit of the patient safety

Content:
The programme will focus on the development process:
• How do I select the right studies at the right time to meet the company’s needs and the regulatory requirements?
• How do I evaluate the results? What is the predictive value of the results?
• What should I know about CMC and clinical development?

Non-clinical studies to support clinical development, including special populations and line extensions,
predictive value of non-clinical studies, risk assessment of non-clinical studies, CTD Module 4 and the non-
clinical part of Module 2. 

• Overview of Pharmacology, Pharmacokinetics and Toxicology
• Timing of Non-Clinical Studies
• Pharmacology
• Pharmacokinetics
• General Toxicity Studies
• Local Tolerance and Other studies
• Application for First in Man
• Carcinogenicity
• Reproduction – including Juvenile Toxicity
• Immunotoxicity
• Interaction with Quality (CTD Module 3)
• Biotechnology Products
• Implications of non-clinical findings for the EU and FDA labelling text
• Life Cycle Management
• Selection of Animal Species, and predictive Value of Non-Clinical Studies
• Risk Assessment – Industry View
• Risk Assessment – Regulatory Body View

Dr. Gerd Bode, FACP, PhD, Consultant, Germany, lecturer at the Universities of Goettingen, Bonn and Essen, in Germany, and at the University of Lyon in France

David Jones, BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist, MHRA, UK

Morten Bagger, Novo Nordisk A/S, Denmark

Allan Dahl Rasmussen. H. Lundbeck A/S, Denmark

David Tweats, Genetic Toxicology Consultant, UK

Ann Christine Korsgaard, Vice President, Regulatory Affairs, Genmab A/S, Denmark

Jørgen Schützsack, Senior Toxicologist, LEO Pharma, Denmark

Andrew Makin, LAB Research (Scantox), Denmark

Graham Bailey, Janssen Pharmaceutics (J&J), Belgium

Vibeke Miller Breinholt, Genmab, Denmark

Tina Zinck, Danish Medicines Agency, Denmark

Paul Baldrick, Head, Regulatory Affairs for Pharmaceuticals within the Consultancy and Regulatory Services Department at Covance-Harrogate, UK

More international lecturers will be added...

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.