Regulatory Requirements and Guidelines
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a dataset collected by the EU Commission in June-September 2018
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Owner/Developer: Safety Sciences for Medicines (safe sci med)
22 January 2018
|Description:||Course Objectives 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 nonclinical 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.. Key Subjects Covered by the Course - 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 of pharmaceuticalså|
Hands-on training, Lecture
Optional / Voluntary
MSc in Life Sciences or equivalent
Students, Researchers, Regulators and policy-makers, Teachers and educators, Technicians, Scientific officers / Project managers
Academia, Industry, Governmental bodies, Contract Research Organizations (CROs), SMEs
Continuing Professional Development, University (Master)
Substantial coverage (e.g. multiple modules)
No species is addressed specifically
|Course level on animal species:||
Directive 2010/63/EU or equivalent, Other
On successful completion of the course, participants should have an integrated view on the regulatory requirements and guidelines relevant for the development
and marketing of new pharmaceuticals. They will understand the type and rationale of the tests required and will identify which data is necessary
in each stage of development. More specifically, participants will be able to
- 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
|Accreditation body and/or authority that approved the education or training:||
3 ECTS credits
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