openPR Logo
Press release

Harmonised GCP Training Courses Launched by Helix Research Center

12-26-2011 06:32 AM CET | Health & Medicine

Press release from: Helix Research Center Ltd

Clinical Trials,Consulting,Educational services Worldwide

Clinical Trials,Consulting,Educational services Worldwide

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.

Helix Research Center Ltd is a London,UK based MNC,providing Clinical Research,Healthcare,Consulting ,Training Services Worldwide

Helix Research Center Ltd,
Office 4 ,219 Kensington high street
W8 6 BD,London,UK

Dr Venkateswar Rao G

This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release Harmonised GCP Training Courses Launched by Helix Research Center here

News-ID: 205319 • Views: 1747

More Releases from Helix Research Center Ltd

Clinical Research Practices Concept to Expedite Global Clinical Trials
Having analysed and understood the Non Clinical & Clinical Trial outsourcing trends in the Global Clinical Research arena and the challenges by being endured by the stakeholders of Research & Development Industry;Viz the Pharmaceutical,Medical Device,Biotechnology and Cosmetic Industry Worldwide , the issues such as Financial constraints,safety and well being of Trial subjects,Errors,Misconducts,negative talk about the Clinical Trial activity itself in one or the other media and the need for introducing
Clinical Research Certificate Programs With Internship In India
It is an established fact that Clinical Research Industry is considered multibillion dollar industry and there can be no 'Recession' for the rapidly increasing dreadful diseases that cause high mortality and morbidity in almost every region of the World,irrespective any global economic slowdown/recession. But the Global Biopharmaceutical ,Medical Device and Cosmetic Industry and other Sponsors of R&D ( Research and Development) have been enduring many constraints including severe financial
Consulting,SMO & Site Support Services for the Global Clinical Trials
In view of the absolute necessity to ensure ,Safety and well being of Clinical Trial Subjects ,strict adherence to Good Clinical Practices Guidelines and Regulations governing Biomedical Research by Doctors of various Therapeutic areas such as Cardiology,Neurology,Oncology,Endocrinology,Pulmonology,Psychiatry,Obstetrics & Gynecology,Gastroenterology,Opthalmology,ENT,Internal Medicine,General Surgery etc,the need to produce quality data for a given study,reduce Regulatory delays,prevent avoidable errors and misconducts during a Clinical Trial,reduce the avoidable overheads for the Clinical Trial Sponsors such
Helix Research Center and AHRO Sign an MOU to provide GCP Training in Africa &Eu …
Inspired by the increasing demand for Trained Professionals in the Africa region and other parts of the World and inorder to contribute their share for ensuring strict GCP Compliance during clinical trials, Helix Research Center (HRC) and Africa Health Research Organization (AHRO) have signed a strategic working relationship on clinical trials program. The AHRO is a not for profit institution with offices spread across West Africa

All 5 Releases


More Releases for Clinical

Clinical solutions
Are you spending more time with yellow files than with patients? Healthbridge can change that with our intuitive and easy to use clinical platform that is designed specifically for the medical practitioner at the practice. smaller2 Easily access patient information Cloud-based technology enables you to store rich clinical information that can be easily accessed as and when you need it. Medical billing software innovation Become a paperless practice Create scripts, sick notes, and clinical notes electronically. Plus, have
Clinical Research and Clinical Trials Summit
Clinical Research 2019 has been designed in an interdisciplinary manner with a multitude of tracks to choose from every segment and provides you with a unique opportunity to meet up with peers from both industry and academia and establish a scientific network between them. We cordially invite all concerned people to come join us at our event and make it successful by your participation. This is the premier interdisciplinary forum for
Clinical Trial Management System
According to a new market report published by Persistence Market Research “Global Market Study on Clinical Trial Management System: Asia to Witness Highest Growth by 2019” the global clinical trial management system market was valued at USD 844.0 million in 2013 and is expected to grow at a CAGR of 14% from 2014 to 2019, to reach an estimated value of USD 1,848.5 million in 2019. Request Report TOC @ https://www.persistencemarketresearch.com/methodology/3017
Clinical Nutrition Conference 2018
Clinical nutrition is essential for patients in healthcare to deal with sickness, injuries, surgery and for proper recovery. It helps in preventing malnutrition, restoring body tissue and boosting energy and immunity in the body. It can be provided with a proper diet plan and feeding the patient with essential foods that revive the patient’s body the patient can also be given healthy supplements for proteins, vitamins etc. The preferred route
Clinical Communication
According to a recent market report published by Persistence Market Research titled “Clinical Communication and Collaboration Market: Global Industry Analysis (2012–2016) and Forecast (2017–2025),” revenue from the global clinical communication and collaboration market was US$ 138.5 Mn in 2012 and US$ 214.8 Mn in 2016, representing a CAGR of 11.6% from 2012 to 2016. This revenue growth is attributed to addition of new features in clinical communication and collaboration solutions.
Europe Clinical Nutrition Market
According to the report “Europe Clinical Nutrition Market,” published by Market Data Forecast, the global market is projected to reach USD 12.45 billion by 2021 from USD 9.65 billion in 2016, at a CAGR of 5.29% from 2016 to 2021. Clinical nutrition is the practice of analysing if a person is consuming an adequate amount of nutrients for good health. A clinical nutritionist is concerned with how nutrients in food are