Customised,Interactive GCP Training Programs In ICH & Non ICH Regions

Online, December 27, 2011 (Newswire.com) - Inspired by the initiative of Sponsors of ICH ( International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals of Human Use) Viz,European Agency for the Evaluation of Medicinal Products ( EMEA),Japanese Ministry of Health,Labour and Welfare (JMHLW) and the US Food and Drug Administration (USFDA) , the Co Sponsors;Viz ,the European Federation of Pharmaceutical Industries' Associations (EFPIA),the Japanese Pharmaceutical Manufacturers Association (JPMA),the Pharmaceutical Research and Manufacturers of America (PhRMA) , the International Federation of Pharmaceutical Manufacturers Associations (IFPMA),the observers- WHO,Health Canada and EFTA ( European Free Trade Association) , the resolution made during Ninth ( Berlin,April 1999)International Conference of Drug Regulatory Authorities (ICDRA), efforts of ICH GCG ( Global Co operation Group ,member countries consisting of Australia,Brazil,China,China Taipei,India,Russia,South Africa,South Korea,Singapore etc) and the RHIs ( Regional Harmonisation Initiatives) such as Asia Pacific Economic Co operation ( APEC),Association of South East Asian Nations ( ASEAN),Gulf Co operation Countries (GCC),Pan American Network of Drug Regulatory Harmonisation( PANDRH),Southern African Development Community( SADC) etc to Harmonise the Good Clinical Practices (GCPs;an International Ethical and Scientific quality standard for designing,conducting,recording and reporting trials that involve Human subjects) ,the feedback received from the Senior Clinical Research Fraternity around the World and the observations made during Regulatory Inspections/Audits etc,Helix Research Center has taken an initative to launch 'Customised,Interactive GCP Certificate Courses' for the working Professionals as well as Life Sciences prospects in ICH and Non ICH regions of the World.

It is a well known fact that Clinical Research itself is a paradoxical activity in any part of the World:The Government of any country;rather Health Ministry,Drug Regulatory Authority of any country is always in favour of New Drug Discovery and the community demands remedies for all the diseases.But unfortunately the R&D Sponsors ;Biopharmaceutical,Medical Device,Cosmetic Industry etc invariably never escape the Wrath of hurdles at every level of New Drug Discovery.There is always a strong objection for Pre-Clinical and Clinical Trials. The news pertaining to burning issues in Clinical Research keep appearing in the media most often and those who are against Clinical Trials can never suggest any alternative for experimentation on Animals or Humans.But for the hundreds of new New Medicines introduced by Multinational Pharma,Biotech companies,new diagnostic and therapeutic devices introduced Medical device companies,the present day increased life expectancy was not possible.

On the other hand,Protection of Human Rights,Confidentiality of Medical Information,ensuring safety and well being of Clinical Trial Subjects is always most important than the interest of the Trial Sponsor and experiment.Luckily ,since the Medical Eduction is Universal ,every doctor/Clinical Research Investigator involved in Clinical Trials is definitely capable of treating Adverse Events and in a nutshell ,protecting the Clinical Trial Subjects.But inroder to obtain permission from the Regulatory Authorities in any country to manufacture and market a new Drug,strict adherence to GCP is only the option and hence all the professionals involved in Clinical Trials;Viz,Clinical Research Associates,Study Coordinators,Research Nurses,Project Managers,Clinical Research Investigators,Pharmacists,Laboratory Staff,Quality Assurance/Clinical Data Management/Pharmacovigilance etc Professonals must be thorough with the Guidelines and Regulations governing Biomedical Research in their country and World in general.

The Customised,Interactive GCP Training Programs being launched by Helix Research Center will focus on familiarising the Trainee with Clinical Research Process in their country,and then ICH,WHO,NIH etc( National Institutes of Health,USA),Guidelines and Regulations in different regions of the World.Since this is an era of 'Internet based Clinical Trials' ,making the Trainee familiar with E Clinical Trials is one of the objectives of the Training Programs being introduced.Moreover,since yet another Global Economic downturn is round the corner, brilliant Life Sciences Graduates,Post Graduates,PhDs ,with good communication skills and profound passion for Clinical Research ,but who are not afford regular high Tuition fee will be able to get GCP Training for a nominal fee.The Trainers involved in providing this new type of GCP Training are senior Professionals who are well versed with Medical Research Guidelines and Regulations in ICH and Non ICH regions of the World and strive hard to impart high quality Training.

Helix is always keen to working with like minded Organisations,groups or Individuals to promote Continuing Clinical Research and Medical Education in any part of the Globe.