Drug Safety of Stem Cells and other Novel Therapeutics
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Owner/Developer: Safety Sciences for Medicines (safe sci med)
06 February 2018
|Course Objectives This will introduce the emerging area of the safety science of the therapeutic application of stem cells, and will address all the key issues that need to be considered by developers of these therapies, including academics and the pharmaceutical/biotech industry, as well as the important area of regulation. Other new areas of therapy will also be considered, such as genetically-engineered cells. The use of stem cells in the screening of conventional drugs for efficacy and particularly safety will also be investigated. UK and European leaders in these fields, from Industry, Academia and the Regulatory Agencies, will contribute teaching sessions in a small, informal and interactive learning environment. Key Subjects Covered by the Course - Basic biology of stem cells and molecular therapies - the key issues: efficacy and safety - Drug safety aspects of stem cells and other novel therapeutic approaches - Introduction to immune system and importance in regenerative medicine therapies - Use of stem cells in safety assessment - where we are - Epigenetic Modificating Therapeutics - Oligonucleotides as novel therapies - New nanoparticles and reporters for imaging - Regulatory requirements for adult and embryonal stem cells and novel therapies
Workshops, Hands-on training, Lecture
Optional / Voluntary
MS 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)
In vitro methods, Legislative aspects
Partial coverage (e.g. a module)
No species is addressed specifically
|Course level on animal species:
On successful completion of the course, participants will have acquired an understanding of the relevance of stem cells and other novel therapeutics for
drug safety research. More specifically, participants will be able to
- gain an understanding of where the science has reached
- appreciate the novelty of these areas and the concomitant challenges to therapy developers and the regulators
- understand that there are still many gaps in our knowledge – i.e. concept of an evolving area
- understand the basic biology that underpins this field and that is being translated into man
- appreciate the utility and possible drawbacks of different preclinical models for assessment of safety
- overview the state of the art in the application of stem cells in safety assessment of conventional compounds
|Accreditation body and/or authority that approved the education or training:
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