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Tutorial 05: NON-CLINICAL SAFETY FOR NON-TOXICOLOGISTS: WHAT IS IMPORTANT FOR YOUR SUBMISSIONS?

Mar 25 2014 9:00AM - Mar 25 2014 12:30PM | Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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Overview 

This tutorial identifies the challenges and solutions for integrating all sources of toxicological data involved and helps to understand the non-clinical development and strategies of drug toxicity or safety assessments. The international state of the art of non-clinical evaluation of pharmaceuticals, the interpretation of toxicological data and the acceptability or unacceptability of toxicological risks (benefit/risk assessments) for pharmaceuticals will be discussed.

This tutorial should attract everybody who is interested in or responsible for non-clinical (toxicological) data. This tutorial does not require specialist knowledge in this area.

Who Should Attend 

Non-specialists in toxicology, regulatory affairs personnel, clinical colleagues, project team leaders and members

Learning Objectives 

At the conclusion of this tutorial, attendees will be able to:

  • Recognise the principles, objectives and strategies of non-clinical safety evaluation of pharmaceuticals
  • Identify the need of interactive discussion of quality, non-clinical and clinical data in drug development
  • Interest in selection and performing of important non-clinical data for submission of pharmaceuticals

Instructor(s) 

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