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Preclinical trials Workshop: "Preclinical and Phase I clinical trials in the Drug Development Process"
The invitation is overdue, registration is closed.
Preclinical trials Workshop: "Preclinical and Phase I clinical trials in the Drug Development Process"
March
19
Thu
9:30 AM
When:
Thu 19 Mar 2015
9:30 AM
-
4:00 PM
(UTC+03:00) Moscow, St. Petersburg, Volgograd
Where:
Гиперкуб
Author:
Voronkov Viktor
Tags:
en
ru
19/30/2015 09:30
19/00/2015 04:00
(UTC+03:00) Moscow, St. Petersburg, Volgograd
Preclinical trials Workshop: "Preclinical and Phase I clinical trials in the Drug Development Process"
Гиперкуб
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Registration
Program:
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.
Partners: