CLINICAL TRIALS 2010

"Clinical Trials: ICH, GCP rules, regulatory (EMEA, FDA) GCP

inspections.Key documents."

international seminar (GCP certification)

March 26, 2010 , Kiev, Ukraine

Registration

( deadline - March 10, 2010 )

Invited Trainers:

Dr. Werner Gielsdorf, HSC- Germany

General Manager of TACIS project of European Commission in CIS, Manager of UNCTAD, WTO, ITC ,

EU, World Bank, UNCTAD/WTO,

trainer of GCP, GLP, GDP,GMP

(Curriculum Vitae)

Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
Member of European Forum of GCP , Gerson
Lehrman healthcare Council, First Clinical Research LLC Speakers
Bureau, former head of consulting Group of the Department of Clinical Research of State Pharmacological Center of MOH of Ukraine

( 2006-2008 ).(Curriculum Vitae)

Babich Pavel
Biostatistican, the Adviser of State Pharmacological Center of MOH of Ukraine ) Engineers-system engineerings. Experience of the decision of tens applied problems with use of statistical methods in clinical trials. Has published about 40 scientific works on application of the statistical methods, one of the basic developers of software PRIAM (Planning, regress and the analysis of models), devoted regress analysis which in 1994 has taken the third place on competition of software products in clinical trials.

(Curriculum Vitae)

Dear Colleague !

On behalf of the NBScience Org. it is our honor and pleasure to announce that 11 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 11 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 11 GCP Meeting.


For the Organizing Committee

Dr. Zadorina Kristina,

NBScience Org.

Registration

Important dates:

Deadline for registration- March 10, 2010

Accreditation

International accreditation has been requested from:
HSC-Germany ,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

Program:

9.00- 10.00 Registration

"Main principles of Good Clinical Practice (GCP). Regulatory acts of the European Union and International Conference of Harmonization (ICH). Responsibilities and the rights of the parties participating in clinical trials. Interaction of Sponsor and Investigator. Responsibilities of Investigator, Sponsor according to principles of Good Clinical Practice (GCP)”

Dr. Werner Gielsdorf, Germany. Project Manager of TACIS of the European Commission in the CIS countries, manager of international organisations UNCTAD, WTO, ITC, EU, World Bank, UNCTAD/WTO, trainer GCP, GLP, GDP, GMP, founder of training centers for GMP/GDP and GCP inspectors in the CIS countries.

"Ethical aspects of clinical trials of medical products. Informed consent. File of Investigator; keeping of documentation.”

Dr. Werner Gielsdorf, Germany. Project Manager of TACIS of the European Commission in the CIS countries, manager of international organisations UNCTAD, WTO, ITC, EU, World Bank, UNCTAD/WTO, trainer GCP, GLP, GDP, GMP, founder of training centers for GMP/GDP and GCP inspectors in the CIS countries.

"Popularization GCP rules in Europe and Ukraine. Review of clinical trials”.

Dr. Zadorin Eugene,PhD,MBA, International Biopharmaceutical Association, European Forum of GCP (EFGCP), chief of advisory-methodical group of SPhC of Ministry of Health of Ukraine (2006-2008)

"Statistical principles of clinical trials by Good Clinical Practice (GCP).”

Babich P. N, Adviser of the State Pharmacological centre of Ministry of Health of Ukraine

Part1 „Legal and regulatory base of clinical trials of medical products in Europe and Ukraine. Laws of SPhC of MOH of Ukraine, FDA and EMEA. The basic requests to the documentation for clinical trials of medical products in Ukraine.”

Part 2 “Regulatory inspections of FDA and SPhC. Types of inspections. Responsibilities of Sponsor, Investigator and Inspector at the time of audits.”

Dr. Zadorin Eugene,PhD,MBA, International Biopharmaceutical Association, European Forum of GCP (EFGCP), chief of advisory-methodical group of SPhC of Ministry of Health of Ukraine (2006-2008)

Practical sessions (Topics: GCP Audit , CT Monitoring)

Trainer - Dr.Werner Gielsdorf

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.

Coffee break

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.

Testing. GCP certification.

Registration

The success of the NBScience international is built on forging profitable business relationships between the Pharmaceutical and Biotechnology industries and their partners in clinical research.
With our 5 years of experience in increasing our partners' return on investment we've developed winning strategies guaranteed to build and sustain successful partnerships in clinical trials outsourcing.

• pharmaceutical companies
• CRO
• Investigators
• GCP,cGMP auditors

NBScience already has many partnerships with societies, universities, statutory organisations and NGOs locally, nationally and internationally. We aim to strengthen these relationships and develop new collaborations in the future.