Clinical Trials: ICH, GCP rules, regulatory (EMEA, FDA) GCP inspections. Key documents.

GCP training on-line (GCP certification)

A training package has been developed on the basis of the documents developed by ICH Steering Committee Members. We wish to thank to:

 

Dr. Peter Arlett
Head of Sector for Pharmacovigilance and Risk Management
European Medicines Agency London UK

 

Dr. Tomas Salmonson
Medical Products Agency
Preclinical and Clinical Investigation Unit Uppsala, Sweden

 

Dr. Christine-Lise Julou
European Federation of Pharmaceutical
Industries Associations – EFPIA Brussels, Belgium

Dr. Andrй W. Broekmans
Schering Plough Research Institute The Netherlands

 

Mr. Shinobu Uzu
Ministry of Health, Labour & Welfare Tokyo, Japan

 

Dr. Satoshi Toyoshima
Pharmaceuticals and Medical
Devices Agency (PMDA) Tokyo, Japan

 

Mr. Kazutaka Ichikawa
Japan Pharmaceutical Manufacturers
Association – JPMA Tokyo, Japan Mr. Kohei Wada
Asia Clinical Development Department
Daiichi Sankyo Co., Ltd. Tokyo, Japan

 

Dr. Justina A. Molzon
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration Rockville, MD, USA

 

Dr. Robert A. Yetter
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration Rockville, MD, USA

 

Dr. Alice Till
Science Policy and Technical Affairs
Pharmaceutical Research and Manufacturers of America – PhRMA
Washington DC, USA

 

Dr. Peter K. Honig
Worldwide Regulatory Affairs and Product Safety
Merck Research Laboratories North Wales, PA, USA

 

Mme Alicia D. Greenidge
International Federation of Pharmaceutical
Manufacturers Associations – IFPMA Geneva, Switzerland

 

Dr. Odette Morin
Director of Regulatory and Scientific Affairs
International Federation of Pharmaceutical
Manufacturers Associations – IFPMA Geneva, Switzerland

 

Mr. Mike Ward
International Policy Division
Bureau of Policy and Coordination
Therapeutic Products Directorate
Health Products and Food Branch Health Canada

Dr. Lembit Rago
Quality Assurance and Safety : Medicines
HTP/EDM/QSM
World Health Organization Geneva, Switzerland

Dr. Petra Doerr
Swissmedic, Swiss Agency for Therapeutic Products
Berne, Switzerland

 

 

Trainers for Eastern European countries:

 

 

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

 

 

Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
, 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, Zintro Inc. (USA )

( 2006-2008 ).

 

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.

Program:

 

“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)”

 

“Ethical aspects of clinical trials of medical products.

Informed consent .

File of Investigator; keeping of documentation.”

 

„Legal and regulatory base of clinical trials of medical products in Europe.

FDA and EMEA.

The basic requests to the documentation for clinical trials of medical products.”

“Regulatory inspections of FDA and SPhC.

Types of inspections.

Responsibilities of Sponsor, Investigator and Inspector at the time of audits.”

“Specific clinical trials and GCP regulations in your country”

 

Testing. GCP certification.

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