Training Course in Safety Sciences - Regulatory Requirements and Guidelines (IMI SafeSciMET), Lisbon

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

Course leaders

Prof. Beatriz Silva-Lima (University of Lisbon)

Dr. Kirstin Meyer (Bayer)

Dr. Per Spindler ( Biopeople, University of Copenhagen)

Location

Lisbon, Portugal

Application deadline

January 9, 2018

Apply to this course

More information and registration at http://www.safescimet.eu/registration/index.php?show=apply&id=142

Biopeople contact: Per Spindler

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.

When

22-01-2018

Location

University of Lisbon, Lisbon, Portugal
Lisbon

Organizer

Bayer Pharma (DE), University of Lisbon (PO), Biopeople (DK)

Close
What are you looking for?
By using this website, you agree to the use of Cookies to give you the best user experience.Ok