A unique opportunity to broaden your knowledge of drug discovery and development with special emphasis on drug safety.
SafeSciMET offers an outstanding faculty of academic and industry experts and an interactive program, including case studies from the pharmaceu=cal industry providing a broad understanding of the latest developments in safety sciences.
Regulatory Requirements and Guidelines
This course will provide participants with a comprehensive overview of the required in vitro and in vivo nonclinical studies, development strategies as well as risk assessment for new pharmaceuticals (small molecules and biologics). While the focus of this course is on the EU perspective, the ICH procedures and guidelines reflecting the international harmonization of requirements (in the EU, US and Japan) are also covered. Special emphasis is put on translational science methodologies of nonclinical data to humans based on an integrated safety assessment. Studies needed for specific patient populations (pregnant women, pediatric, 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.
Key subjects
- Drug development process and regulatory requirements
- EU & ICH guidelines and the Common Technical Document
- ICH guideline on nonclinical safety
- Extrapolation of animal data, human translation and risk assessment
- Species selection for nonclinical studies and 3Rs principles
- Reproductive toxicity testing, pregnancy labeling
- Testing genotoxic and carcinogenic potential
- First in Human studies and regulatory guidelines for safe dose estimation
- Nonclinical safety testing of biologics
- Environmental risk assessment of pharmaceuticals
Learning outcomes
- Understand the concept of “relevant species” and recognize the value of its use for human extrapolation of nonclinical study outcomes
- Plan the nonclinical safety programs for different types of pharmaceuticals and understand the translational aspects of medicines development
- Know and understand the European and international nonclinical regulatory guidelines and the situations where they will apply or deviate
- Adapt the standard protocols into specific situations, e.g. pathologies, patient populations
- Use and integrate the information from multiple sources / studies as a weight of evidence approach for human risk assessment
SafeSciMET Executive Office
University of Konstanz
Universitätsstraße 10
P.O. Box 622
78457 Konstanz
Germany
Phone: +497531 88 3518 / 3171
To contact us or to register to our courses visit:
Enable JavaScript to view this email address. www.safescimet.eu
SafeSciMET is currently supported by Hoffmann-La Roche, Sanofi, Bayer Healthcare AG and Dept. Human & Environmental Toxicology at the University of Konstanz
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