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.
The “Non-Clinical Safety Sciences and Their Regulatory Aspects” training course has been accredited with 5 ECTS credits by the University of Lisbon, Portugal. DIA meetings and training courses are generally approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits.
What You Will Learn
- 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
Who Should Attend
Professionals in preclinical research and development, project management, regulatory affairs, medical writing, clinicians for Phase 1, and pharmacovigilance. The course is valuable for professionals in regulatory agencies outside Europe. Participants should preferably have a previous fair understanding of aspects of medicines development and registration.
At the conclusion of this course, participants should be able to:
- Discuss the scope and needs for preclinical safety programmes 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
Hotel & Travel
DIA has blocked a limited number of rooms at the following hotel:
Rua Duque de Palmela, 34
Tel.: +351 21 357 61 45
Fax: +351 21 314 13 47
at the rate of:
EUR 80.00 per single room inclusive of American Buffet Breakfast, WIFI, all taxes and services.
To make your reservation, please use this booking form.
Important: The room rate is available until 30 January 2014 or until the group block is sold-out, whichever comes first.
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52