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safescimet course 2.2 - Regulatory Requirements and Guidelines

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. 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.

Lisbon, Portugal

On-site course dates

Course leader 
Prof Beatriz Lima
Couse certificate 
CPD, ECTS, MSc optional
Course fees 
  • Company - 2.500 EUR
  • Small and medium companies (up to 250 employees) - 1.250 EUR
  • Regulatory authorities (government) - 1.250 EUR
  • Academic institutions (universities) - 500 EUR