Faculty of Pharmacy, University of Lisbon , Lisbon, Portugal
Nov 21 2011 7:00AM - Nov 25 2011 3:00PM
Featuring tailor-made case studies including in-depth discussion of specific contemporary scientific/regulatory preclinical issues, case-studies and/or instructor-led group work on specific cases. This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines. Key Topics - Role of preclinical safety studies in medicines development and registration in Europe
- Outline of preclinical medicines discovery and development, regulatory and industry perspectives
- Translational aspects of preclinical safety sciences, including safety biomarkers
- Scope and type of preclinical safety studies and timing to clinical development and registration
- Contemporary scientific and regulatory topics of interest: environmental risk assessment, single and repeat dose toxicity, establishing first human dose, juvenile animals studies, safety pharmacology, toxicity to the immune system, genotoxicity carcinogenicity testing, pharmaco-toxicokinetics, metabolism, reproduction toxicology protocols and interpretation for pregnancy labelling of pharmaceuticals, when mechanistic studies are needed, impurities and others
- Specific aspects of e.g., vaccines, anticancer medicines, biotechnology-derived medicines
- The Common Technical Document and Assessment Report structures in Europe may be included on case-by-case basis
Event Code:
11567
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