ICH GCP,Clinical Research Investigator Certificate Course for Doctors Worldwide

Sept. 24, 2010 - PRLog -- Uk based MNC,Helix Research Center Ltd has launched 'ICH GCP'Clinical Research Investigator Course 'for Doctors of Medical  and Surgical Specialties,conducting Clinical Trials Sponsored by Biopharmaceutical,Medical Device,Cosmetic Companies,Government and Global Voluntary bodies ( HHS,NIH,WHO etc) promoting Research and Development (R&D) activities in North America,South America,Europe,Asia and Oceania.

ICH stands for the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use. USA,Japan and EU are responsible for forming ICH in 1990..GCP is defined as 'an International Ethical and Scientific quality standard for designing,conducting,recording and reporting trials that involve the participation of Human Subjects.GCPs are derived from the Federal Regulations,Ethical Codes and Official Guidance Documents.According to 21 CFR  312.3,' an Investigator means an individual who actually conducts of Clinical Investigation'.

Clinical Research Industry is a 'Rose with Thorns' indeed.Rose ,because the beneficial effects of the New Drugs are plenty and many fatal diseases are being treated with New Drugs being developed by Global R&D Companies.Thorns 'because there are many hurdles and constraints in the Drug Discovery Process.If 5000 compounds with a medicinal property are selected by an R&D company,only 250 compounds reach Pre-Clinical ( animal testing stage),5 compounds reach Human testing stage and only one Molecule is approved.The average expenditure involved in bringing a New Molecule to the market is USD 600 to 900 Million and the average daily loss for the Sponsor company when the prospective Molecule does not reach the market on time is USD 1 million!.The Research Process;Pre Clinical Research,Bio Availability and Bio Equivalence Studies,Phase 0 through IV Trials usually takes around 10 years and a 'Futile' study would cost the Sponsor huge financial loss.

Below are some of the Human Subject Protection Milestones,especially in the United States of America:
Drug Importation Act of 1848
Bureau of Chemstry Formation-1862
Food and Drug Act -1906
Food,Drug and Cosmetic Act-1938
Nuremberg Code-1947
Kefauver-Harris Amendments ( Drug Amendments) -1962
Declaration of Helsinki-1964
Belmont Report-1979
IND Rewrite Regulations-1987
-Tuskegee Syphilis study
-Jewish Chronic Disease Hospital Study
-Acres of Skin
Expedited NDA Approval Process for Life Threatening Illnesses-1988
Prescritpion Drug User Fee Act (PDUFA_-1992
FDA Modernisation Act (FDAMA)- 1997
Formation of ICH -1990

The number of killer diseases across the Globe is increasiing exponentially and hence there is a dire need for  all the Countries in the World to promote R&D activities.Global Recession has 'Strained ' almost all the R&D companies across the World and the World is getting ready for another 'Impending Economic Recession'.In view of this 'Harsh Reality' being endured by Global Biopharmacetical,Device and other Sponsors,there is dire need to ensure Successful conduct of Clinical Trials .

The main issues in the Global Clinical Research arena are Safety and Well Being of Human Subjects taking part in Clinical Trials,Protection of Confidentiality of Medical Information,Protection of Human Rights ,Poor Execution of Informed Consent Process,Subject drop out,Protocol deviations,Errors and Misconducts etc.


Clinical Research is different from Clinical Practice and unfortunately the Medical Curriculum does not cover the Guidelines and Regulations Governing Biomedical Research.However,for the Doctors who have studied Gray's Anatomy,Robbin's Pathology,Harrison's Text book of Medicine,Oxford Text book of Medicine etc ,Learning ICH GCP,Guidelines and Regulations in their country is not that difficult.
ICH GCP,Clinical Research Course being Offered by Helix Research Center makes the Trainees familiar with; Roles and Responsiblities of a Clinical Research Investigator,various Guidelines and Regulations Governing Biomedical Research across the Globe.The Training is imparted by experienced Clinical Research Professionals in Online/Inclass.Distance Learning/Online Live Mode.

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Helix Research Center Ltd is a London(UK) based global company offering Contract Research,Training,Auditing,Consulting,Medical Writing,Pharmacovigilance,Biostatistics,SMO,Regulatory Affairs,Quality Assurance,Publications,Translation ,CDM services globally