SafeSciMET Courses on regulatory requirements and guidelines Lisbon, Portugal
Drug development and production underlies laws and regulations to secure protection of human, test animals and the environment. Guidelines provide advice to applicants on specific scientific issues reflecting a harmonized EU approach to fulfil the pharmaceutical legislation.A course, organized by SafeSciMET, will take place in Lisbon, Portugal and will run from 22 – 26 January 2018 to 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) will also be 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.