Non-Clinical Safety Sciences and Their Regulatory Aspects

Venue: Faculty of Pharmacy, University of Lisbon

Location: Lisbon, Portugal

Event Date/Time: Nov 22, 2010 End Date/Time: Nov 26, 2010
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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

Learning Objectives:

At the conclusion of this course, participants should be able to:

Discuss the scope and needs for preclinical safety programs in relation to clinical trials in Europe
Discuss calculations of First-In-Human doses
Identify requirements for successful preclinical medicines development in Europe
Describe European culture and complexity in the registration system
Explain the fundamentals of preclinical medicines development in Europe, and in ICH environment
Share recent real world experiences of preclinical medicines development agencies and companies in Europe

Target Audience:

Professionals in preclinical research and development, project management, regulatory affairs, medical writing, clinicians for Phase 1, and pharmacovigilance. The course is valuable for professional in regulatory agencies outside Europe. Participants should preferable have a previous fair understanding of aspects of medicines development and registration.

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