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

 

 

GCP training on-line (GCP certification)

 

For registration please send us e-mail to:

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head_office@nbscience.com

 

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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

 

 

 

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,
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

( 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.

 

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For registration please send us e-mail to:

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head_office@nbscience.com

 

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.

For registration please send us e-mail to:

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head_office@nbscience.com

 

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Our Partners:


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Sheraton Hotel Montazah


 

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Contract Research Organizations

 

 

 

 

 

 

 

 

 

 

 

 

good clinical

 

quality assurance1) Quality of our services confirmed by audits.

2) International level of GCP / GMP / ISO trainers and auditors.

3) You can check at any time any GCP / GMP / ISO certificate for authenticity.

medical training

06 November 2011

Current GCP Audit - contract research organization (CRO)

(98%)

 

read more

Contracts signed with GCP / ISO auditors from the U.S.A.

 

read more


Gift for each medical conference participant: Flash drive 2 GB Kingston DataTraveler (DTI / 2Gb) !

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read more

 

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in United Kingdom:

NBScience limited,

788-790 Finchley Road,

London, NW11 7TJ,

United Kingdom

Registered company number: 7083138

e-mail: head_office@nbscience.com

good manufacturing Skype: ich-gcp

 

 

medical education ICQ: 556600040

 

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