ICH GCP -2008
"Clinical Trails: ICH, GCP rules, regulatory (EMEA, FDA) GCP
inspections.Key documents."
international seminar (GCP certification)
September 27, Kiev,Ukraine
Invited Lecturer: Dr. Werner Gielsdorf,Germany
(click here)
Dear Colleague !
On behalf of the NBScience Org. it is our honor and pleasure to announce that 3rd ICH GCP meeting :
"ICH, GCP rules, regulatory (EMEA, FDA) GCP
inspections.Key documents."
will be held in Kiev, Ukraine. We would like to cordially invite you to participating in this biannual meeting .
The major aim of the 3rd GCP Meeting is to bring together scientist from all around the world who are mostly focused in their research and studies on ICH GCP, clinical trials. We strongly believe that such a meeting makes for an excellent occasion to exchange and share recent achievements and ideas in this fascinating field of medicine.
We also believe that Kiev – the heart of Ukrainian science and culture – will enchant you with the beauty of its architecture and very specific artistic atmosphere. You are very welcome to join us to touch history and to share in the new spirit and ideas to modern theoretical and applied medicine.
You are very welcome to join us to touch history and to bring new spirit and ideas of modern medicine. We are looking forward to seeing you soon in Kiev on 3rd GCP Meeting.
For the Organizing Committee
Dr. Kulik Olga,
NBScienceOrg.
Registration
Call for abstracts
Important dates
Accreditation
International accreditation has been requested from:
European Forum of GCP ,CRDE ,NBScience
GCP certification
GCP certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. The NBScience's certification is granted in recognition of documented and verified work experience and successful performance on a multiple-choice exam.
Sponsoring & Exhibition
Social program
Visa procedure
Hotels, Flights
Program:
9.00 Introduction
10.00 -Estimating the savings in total costs of clinical trials
Grants for investigators
Practical advice using international open standards (GCP,GMP,GLP)
New data of clinical trials in US and Europe
Clinical Pharmacology and AE Reporting
Dr. Werner Gielsdorf,Healthcare Services and Consulting (HSC),Germany
GCP, GLP, GDP, GMP trainer.
Project Manager of Tacis project,EU, World Bank, UNCTAD/WTO,
training Centre for GMP/GDP and GCP inspectors
10.30-Development and the Research Budget
Dr. Werner Gielsdorf,Healthcare Services and Consulting (HSC),Germany
GCP, GLP, GDP, GMP trainer.
Project Manager of Tacis project,EU, World Bank, UNCTAD/WTO,
training Centre for GMP/GDP and GCP inspectors
11.00-Good Clinical Practices
What effect has the Directive had on clinical research?
INTERNATIONAL CLINICAL TRIALS AND OPERATIONS
Using the experience gained to expand further into Europe
Dr. Werner Gielsdorf,Healthcare Services and Consulting (HSC),Germany
GCP, GLP, GDP, GMP trainer.
Project Manager of Tacis project,EU, World Bank, UNCTAD/WTO,
training Centre for GMP/GDP and GCP inspectors
11.30-11.45 - Coffee break
11.45-12.15 ICH Guidelines
Is ICH GCP still meeting all needs?
The EU Clinical Trial Directive
Beata Drobniak, GCP trainer,CRDE, European Forum of GCP
12.15 -Informed Consent
Beata Drobniak, GCP trainer,CRDE, European Forum of GCP
12.45 -Preparing for an FDA Audit
Beata Drobniak, GCP trainer,CRDE, European Forum of GCP
13.15 -Regulatory Affairs and IRBs (IND/NDA)
Beata Drobniak, GCP trainer,CRDE, European Forum of GCP
13.45-14.30 Lunch
14.30-
Research Ethics
Source Documentation and Administration
Prof.Lizogub V.G.,Deputy Director of State Pharmacological center of Ministry of Health of Ukraine
15.00-
Genetics
Prof.Lizogub V.G.,Deputy Director of State Pharmacological center of Ministry of Health of Ukraine
15.30-15.45 Coffee break
15.45-Clinical Laboratory Analysis
Beata Drobniak, GCP trainer,CRDE, European Forum of GCP
16.15-Epidemiological and Statistical Issues.
Babich P.N, State Pharmacological center of MOH, consultant
16.45 - ICH GCP practical course ( documetation).
Dr.Zadorin Yevgen, PhD,MBA ,Member of European Forum of GCP ,International Biopharmaceutical Association
17.00 - ICH GCP testing.
Dr.Zadorin Yevgen, PhD,MBA ,Member of European Forum of GCP ,International Biopharmaceutical Association
18.00 ICH GCP certification from European Forum of GCP and NBScience
Session Descriptions
Clinical Pharmacology and AE Reporting - Understanding the presentation and detection of adverse drug events, the pharmacodynamic and pharmacokinetic mechanisms of reactions, methods of causality assessment, safe medication practices in clinical research, and the FDA’s Risk Management Program.
Development and the Research Budget - Review of (drug, device, biologics) development program, including protocol development, Case Report Form design, project and program management, assessing costs and building budgets. How to develop budgets and strategies for reducing costs (at the investigational site).
Drug Development Process - Review and discussion regarding the definitions, regulations and processes from IND to NDA. This session includes Regulatory Affairs and IRBs (IND/NDA) - Review of federal regulations, IRB guidelines, written procedures, and record keeping requirements for clinical trials management.
ICH Guidelines - Discussion about the development and implementation of the International Committee on Harmonization, the clinical research guidelines resulting from that collaboration, and how the ICH Guidelines affect the clinical Researcher.
IRBs and the Informed Consent Process - Discussion of regulations, generally accepted policies and procedures, and audit practices associated with IRBs and the informed consent process.
Preparing for an FDA Audit - Perspectives and regulations regarding adherence to protocol, patient rights, informed consents, and regulatory issues related to an FDA audit.
Research Ethics - The importance of the informed consent and the principles of medical research ethics are discussed as well as therapeutic misconceptions, randomizations, and placebos. This session includes Regulatory Affairs and IRBs (IND/NDA) - Review of federal regulations, IRB guidelines, written procedures, and record keeping requirements for clinical trials management.
Source Documentation and Administration - Review of procedural and management issues regarding utilization and disposition of source documents.
Epidemiological and Statistical Issues - The study of the distribution and determinants of health related events in certain populations.
Genetics and Pharmacogenetics - A review of the development and science supporting these interventions.
Research Ethics - The importance of the informed consent and the principles of medical research ethics are discussed as well as therapeutic misconceptions, randomizations, and placebos.
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