Training Course in Safety Sciences - Regulatory Requirements and Guidelines (IMI SafeSciMET), Lisbon
This course will provide participants with a comprehensive overview of the required in vitro and in vivo nonclinical studies, strategies for the development and risk assessment of new pharmaceuticals.
While the focus of this course is mainly on the EU perspective, the ICH procedures and guidelines reflecting the international harmonization of requirements (in the EU, US and Japanese) are also covered.
Special emphasis is put on the translational science methodologies for the transfer into humans of non- clinical data generated from integrated in vitro and animal models. The study needs for specific patient populations (pregnant women, paediatric, geriatric) are also part of this course’s curriculum.
At course completion students will have knowledge of the type and rationale of the tests required and will be able to determine which data need to be generated in each situation and for which stage of the development.
On-site course dates
January 22, 2018 - January 26, 2018
Prof. Beatriz Silva-Lima (University of Lisbon)
Dr. Kirstin Meyer (Bayer)
Dr. Per Spindler ( Biopeople, University of Copenhagen)
January 9, 2018
Apply to this course
More information and registration at http://www.safescimet.eu/registration/index.php?show=apply&id=142
The SafeSciMET courses are tailor-made to meet the needs of Safety Sciences in all phases of medicines research and development, encompassing safety, ethical, regulatory and societal topics. Emphasis is on holistic, integrative, translational and 3Rs aspects, lacking largely in other educational and training programmes. It’s aligned with the Bologna process for academic education and training in Europe and given by academic top institutes, industrial experts for real-life cases, and regulatory specialists. Competence-directed learning approaches are implemented, and modern e-learning strategies are taken advantage of.
Supported by and part of the Innovative medicines Initiative.
University of Lisbon, Lisbon, Portugal
Bayer Pharma (DE), University of Lisbon (PO), Biopeople (DK)