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Preclinical trials Workshop: "Preclinical and Phase I clinical trials in the Drug Development Process"

Thu 9:30 AM
Thu 19 Mar 2015 9:30 AM - 4:00 PM (UTC+03:00) Moscow, St. Petersburg, Volgograd




Moderator: Kamila Zarubina, BMT Cluster


09:30 – 10:00 Welcome coffee. Registration.
10:00 – 10:30 Regulatory aspects of preclinical trials development in Russia.
  • Maria Zaytseva, Preclinical trials manager, OCT.
    Conception of the multicenter preclinical trials organization in accordance with the GLP rules. Harmonization of regulatory framework. Accreditation of Russian research centers.
10:30 – 11:30 Role of preclinical toxicology in process of pharmaceutical and biotechnology development.
  • Ivana Surova, MediTox s.r.o.
    Phases of drug development.
    Regulation (EMA, ICH/VICH, US FDA, OECD, ISO 10993).
    Requirements for preclinical assessment within individual phases of drug development.
    Requirement for preclinical assessment of drugs, biological and medical devices.
11:30 – 12:30 The role of GLP and GMP requirements in preclinical development.
  • Ivana Surova, MediTox s.r.o.
    GLP, GMP requirements.
    Ethical Committee, Ethical approval (Dir 2010/63/EU).
12:30 – 13:30 Lunch.
13:30 – 14:30 Types of preclinical studies I-II.
  • Lucas Rechek, MediTox s.r.o.
    Drugs, medical devices, Test systems (in vitro, ex vivo, in vivo).
    Genotoxicity, immunotoxicity, safety pharmacology, acute, sub-chronic and chronic toxicity.
    Reproduction toxicity, carcinogenicity, neurotoxicity, ADME, PK/TK.
    Alternative methods in preclinical toxicology.
14:30 – 15:10 Phase I clinical trials. Regulatory aspects.

  • Andrey Ladutko, MD, PhD, Director of science “Smooth Drug Development”
    Medical documentation for a phase I clinical trial: key aspects of development (on the example of an anticancer drug).
  • Vladimir Chistyakov, expert in clinical trials OCT.
    Rational approach for the choice of the doses of investigational drugs in first-in-human trials. Considerations for anticancer drugs.
15:10 – 15:40 Investigational Centers for early phase clinical studies.

  • Polina Khlyabova, Deputy Chief Medical Officer of Clinical research unit BioEq.
    Specifics of early phase clinical studies: first-hand experience
15:40 – 15:50 Regulatory aspects of preclinical trials development in Russia.

  • Artur Shagabutdinov, Head of clinical trials department, Pirogov Russian National Research Medical University.
15:50 – 16:00 Discussion and questions.