Certificate in Clinical Research and Pharmacovigilance
Duration of COURSE – 3 Months
Minimum eligibility criteria for application to the online clinical data management course would be either of the following:
MBBS | BAMS| BDS| BHMS| Physiotherapy and Occupational Therapy Graduates | B.Pharm/M.Pharm & Graduates/ Post Graduates in Sciences/Life sciences/ BioSciences with any of the following subjects-Chemistry, Botany, Zoology, Biochemistry, Microbiology, Genetics and Biotech.
Our award-winning Certificate in Clinical Research & Pharmacovigilance program is India’s first and till date the most sought-after programme within the science fraternity.Industries with Clinical Research has grown around the world at an unparalleled rate in the past few years. It has opened up scope for Clinical Research with 100% placements.
It provides participants in the online course in clinical research with a broad understanding of the basic principles employed within it both domestically and internationally.
What will you study
- Module I – Introduction to Clinical Research
- Module II – Basic Pharmacology and Pharmacy in Clinical Research
- Module III – New Drug Development
- Module IV – Ethical Guidelines in Clinical Research
- Module V – Ethics in Clinical Research
- Module VI – Regulations in Clinical Research
For Doctors: Principal Investigators / Co-investigator / Medical Advisor / Drug Developers / Regulatory Affairs Manager / Clinical Research Physician
For Paramedics, Pharmacists & Life Science Graduates: Medical Writers / Clinical Research Associates / Site coordinators / Clinical Research Manager / Drug Development Associates / Clinical Data Management / Pharmacovigilance Executive / Clinical Trail analyst / Drug Reviewer / Drug Safety Physician & many more.
For Management Professionals: (with Life Science/Health Science background): -Business Development / Clinical Project Management / Clinical Research Management / Regulatory Affairs
Clinical Research Investigators: Conduct BA/BE studies, writing / revising SOP, review of protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC.
Study Coordinators: Provides safety & protection while collecting & managing the study data.
Data Manager / Biostatistician: Design, study & predict the seriousness of the disease, seriousness of the disease, evaluate new treatments and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
Regulatory Affairs Managers: Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
Clinical Trials Auditors: Conducts audits for regulatory function within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
Clinical Data Manager: Ensures the accuracy & consistency in data prepared for regulatory bodies for reporting purpose.
Others: Auditors, Quality Assurance, Patents & IP Related position
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