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Learning Outcomes

Principle learning outcomes of the SafeSciMET programme are novel competences in integrative translational safety sciences. It is contributing to  a new type of safety scientists, who are able to perform a holistic and critical evaluation of the safety of drug candidates and new medicines in context of drug development and usage by evaluating and integrating in vitro as well as animal and patient safety data more effectively. How to better assist the implementation of the 3Rs concept – and thereby reducing the overall use of experimental animals – is also part of the programme.

Regulatory scientists will become better equipped to judge the safety data and profiles of new and existing medicines. Scientists from academia, including in the New Member States of Europe, get a chance to acquire unique industrial know-how and an integrated understanding of safety aspects and its impact on drug discovery, development and use.

All courses in the SafeSciMET programme allow participants and professionals to develop a high level of understanding of a specialised area of the drug discovery, development and safety regulatory process. In general, successful participants of any of the SafeSciMET courses are expected to:

  • Be able to identify and concisely formulate a drug safety sciences problem to be solved and/or a hypothesis to be tested.
  • Have acquired a thorough, critical and scholarly appreciation of the current scientific literature of a specialised area of medicines safety sciences and understand the limitations of current knowledge in that area.
  • Apply a translational and scientific integrative and holistic approach to their chosen problem.
  • Be able to analyse and interpret their findings, taking into account previous work.
  • Effectively present the results of such an investigation, both in writing and in oral presentation.
  • Be able to design translational studies or interventions.
  • Be able to identify, evaluate and apply appropriate methodologies.
  • Be able to critically analyse results using statistical methods.

The course objectives and the associated learning outcomes of the individual courses are highly specific and are defined in the relevant course documentation. Please consult the Course Brochures.

Overall, networking aspects between industry, academia and regulatory authorities add additional significant value to the course programme, thereby supporting personal continuing professional development.

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Last modified: February 25, 2013