Post Graduate Diploma in Clinical Research and Pharmacovigilance
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They imparted training and certification course to eleven members of Ethics Committee on Clinical Research & Regulatory Guidlines with ZYDUS Hospitals.
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Postgraduate
Blended
*Indicative price
Original amount in INR:
₹ 32,000
Description
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Type
Postgraduate
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Methodology
Blended
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Duration
Flexible
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Online campus
Yes
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Delivery of study materials
Yes
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Support service
Yes
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Personal tutor
Yes
Career options are booming and GIHS will provide Dual Certification for National and International countries, so students can apply in abraod also, Global Institute of Health Science name itself holds value for perfection and better future.
Facilities
Location
Start date
Start date
About this course
The program objective is to understand the key concepts in the responsible conduct of research and be able to conduct research that conforms to the highest standards for the protection of human research subjects. It can be able to critically appraise the medical scientific literature, including the methodology of published and proposed investigations. It can be able to independently formulate a research question, as well as be able to design and conduct a study to address that question. It can be able to present and publish the results of one’s scholarly work. It is to identify a focus for future research and scholarly work, and to develop special expertise in the corresponding clinical domain and/or research methods. It would help you to gain in-depth knowledge on the best way to collect and report adverse events and safety data and manage the risk associated with and risk to your products. Its unique format will provide you with the key skills and knowledge needed to operate a fast, effective drug safety or pharmacovigilance program.
Career Options:
Director
Associate Director
Project Manger
Asst. Project Manager
Pharmacovigilance Associate
Pharmacovigilance Assistant
Clinical Research Associate
Clinical Trial Assistant
All Science Graduates, MBBS, BDS, BHMS, BAMS, BPT, BUMS, BPharm, Mpharm, Pharmacy, Occupational Therapist, Bsc, Msc, Life science, Medical Laboratory, Nursing, Microbiology, Biomedical, Biotech and all professionals working with Hospitals & Healthcare Organizations.
Reviews
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They imparted training and certification course to eleven members of Ethics Committee on Clinical Research & Regulatory Guidlines with ZYDUS Hospitals.
← | →
Course rating
Recommended
Centre rating
Zydus Hospitals
Subjects
- Evaluation
- Global
- Project
- Medical
- Clinical Research
- Clinical Studies
- Clinical Trial
- Medical training
- Manufacturing Production
- Pharmacovigilance
- Research
- Medicine
- Pharmacy
- USFDA
- MHRA
Teachers and trainers (1)
Professional Coordinator
Healthcare Specialist
Course programme
Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is the INDIA’s first Online Institute and an ISO 9001:2008 Certified health science Institute, also certified with copyright approval from MHRD (Higher Education) Government of INDIA. GIHS have certification from UK for Quality Control Management System.
Syllabus
Clinical Research
· Introduction of clinical research
Clinical Trial Phases
Pharmacological Principal Of Clinical Research
Drug Development And Launch
· Indian Regulation (domestic regulation)
ICH GCP
Schedule Y
ICMR
Indian GCP
· Key Stakeholders In Clinical Research
Ethics Committees And Institutional Review Board
Responsibilities Of Sponsor
Responsibilities Of Investigator
Responsibilities Of Sponsor – Investigator
Responsibilities Of Sponsor – Vendor
· Clinical Trial Design And Project Managements
Clinical Trial Design
Vendor Selection And Managements
Project Planning
Project Managements
· Principles of good clinical practices
Protocol Design
CRF Design
· Essential documents in clinical research and regulatory requirements
Essential Documents
IND Application
Clinical Study Report
NDA Application
Informed Consent process And Documentation
· Study setup process
Site Selection And Pre- Study VIsits
Site Initiation
Subject Recruitment And Retention Planning
Site Contract And Budgeting
· QC, Compliance & Auditing in Clinical Research
21 CRF Part 11
Site Auditing
Sponsor Compliance And Auditing
SOP For Clinical Research
· Clinical Monitoring
CRF Review & Source Data Verification
Drug Safety Reporting
Drug Accountability Work
Routine Site Monitoring
Site Close Out Visit
PHARMACOVIGILANCE
· Introduction of Pharmacovigilance
Overview Of Pharmacovigilance
Standard Terms And Terminology In Pharmacovigilance
· Medical Evaluation Of Adverse Events In Pharmacovigilance
Adverse Event Reporting System And Form
Diagnosis And Managements Of ADRs
Medical Evaluation Of AE
· Case Processing
Global Perspective Of Pharmacovigilance
Single Case Processing
Case Narrative Writing
· Pharmacovigilance Reporting Database , Signal Detection , Managements And Risk Assessments & Evaluation
Quality System In PV
Expedited Reporting Criteria
PSUR & PBRER
PV Database And Signal Detection
Risk Assessments & Management
· Medical Dictionary For Regulatory Activities medDRA
medDRA
PV laws And Guideline
Regulatory Guideline @ Laws In PV
SOPS In PV
PV Auditing And Inspection
Regulatory Aspects In PV
Additional information
Post Graduate Diploma Program (One Year) – 32000/- INR & Fee
s for International Candidates – 699 $ USD
Fast Track PG Diploma Program (4 Months) – 36000/- INR & Fees for International Candidates – 750 $ USD
Online Registration & Admission Process:
Candidate have to fill the online registration form and have to upload passport photograph and signature. After the submission of online registration form candidate will receive mail regarding Acknowledgement Letter & Fee Payment Instructions. Candidate have to pay the program fee within 7 working days on given bank information.
After fee payment candidate have to send scan copy of Bank Deposit Slip and Final year Mark-sheet or Degree Certificate or Provisional Certificate with your Admission Details (Application ID & Name) at Email: info@gihsonline.com.
MODE OF EXAMS Our IT department will provide you ID & Password for online examinations after completion of program. You will have 7 days to appear online exams. Your examination pattern would be Multiple Choice question MCQ and also need to submit power point project of minimum 30 pages of your own selected topic. After qualifying the exams, GIHS will deliver the two certification one would be DEGREE & second would be TRANSCRIPTIONAL Degree.
Post Graduate Diploma in Clinical Research and Pharmacovigilance
*Indicative price
Original amount in INR:
₹ 32,000