Post Graduate Diploma in Clinical Research and Pharmacovigilance

Post Graduate Diploma

Distance

₹ 28,000 VAT incl.

Description

  • Type

    Post Graduate Diploma

  • Methodology

    Distance learning

  • Duration

    Flexible

  • Start date

    Different dates available

  • Delivery of study materials

    Yes

  • Support service

    Yes

Description

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

Distance learning

Start date

Different dates availableNow taking bookings

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.

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.

Questions & Answers

Ask a question and other users will answer you

Who do you want to respond to your question/enquiry?

We will only publish your name and question

Subjects

  • Pharmacy
  • Clinical Trial
  • Clinical Studies
  • Clinical Research
  • Pharmacovigilance
  • Research
  • Medicine
  • USFDA
  • MHRA
  • Manufacturing Production

Teachers and trainers (1)

Vijay Sharma

Vijay Sharma

CEO

Course programme

CLINICAL RESEARCH & PHARMACOVIGILANCE


Here are the detail syllabus of the PG D.

CLINICAL RESEARCH
CONTENTS


Section -1 introduction of clinical research
Chapter – 1 Introduction of Clinical Research
chapter – 2 Clinical Trial Phases
Chapter – 3 Pharmacological Principal Of Clinical Research
Chapter – 4 Drug Development And Launch

Section – 2 Indian Regulation (domestic regulation)
Chapter – 1 ICH GCP
Chapter – 2 Schedule Y
Chapter – 3 ICMR
Chapter – 4 Indian GCP

Section – 3 key Stakeholders In Clinical Research
Chapter – 1 Ethics Committees And Institutional Review Board
Chapter – 2 Responsibilities Of Sponsor
Chapter – 3 Responsibilities Of Investigator
Chapter – 4 Responsibilities Of Sponsor – Investigator
Chapter – 5 Responsibilities Of Sponsor – Vendor

Section - 4 Clinical Trial Design And Project Managements
Chapter – 1 Clinical Trial Design
Chapter – 2 Vendor Selection And Managements
Chapter – 3 Project Planning
Chapter – 4 Project Managements

Section - 5 principles of good clinical practices
Chapter – 1 Protocol Design
Chapter – 2 CRF Design

Section – 6 Essential documents in clinical research and regulatory requirements
Chapter – 1 Essential Documents
Chapter– 2 IND Application
Chapter – 3 Clinical Study Report
Chapter – 4 NDA Application
Chapter – 5 Informed Consent process And Documentation

Section – 7 study setup process
Chapter – 1 Site Selection And Pre- Study VIsits
Chapter - 2 Site Initiation
Chapter – 3 Subject Recruitment And Retention Planning
Chapter – 4 Site Contract And Budgeting

Section – 8 QC, Compliance & Auditing in Clinical Research
chapter – 1 21 CRF Part 11
Chapter – 2 Site Auditing
Chapter – 3 Sponsor Compliance And Auditing
Chapter – 4 SOP For Clinical Research

Section – 9 Clinical Monitoring
Chapter – 1 CRF Review & Source Data Verification
Chapter – 2 Drug Safety Reporting
Chapter – 3 Drug Accountability Work
Chapter – 4 Routine Site Monitoring
Chapter – 5 Site Close Out Visit

PHARMACOVIGILANCE
CONTENTS


Section – 1 Introduction of Pharmacovigilance
Chapter – 1 Overview Of Pharmacovigilance
Chapter – 2 Standard Terms And Terminology In Pharmacovigilance

Section – 2 Medical Evaluation Of Adverse Events In Pharmacovigilance
Chapter -1 Adverse Event Reporting System And Form
Chapter – 2 Diagnosis And Managements Of ADRs
Chapter – 3 Medical Evaluation Of AE

Section – 3 Case Processing
Chapter - 1 Global Perspective Of Pharmacovigilance
Chapter - 2 Single Case Processing
Chapter – 3 Case Narrative Writing

Section – 4 Pharmacovigilance Reporting Database , Signal Detection , Managements And Risk Assessments & Evaluation
Chapter – 1 Quality System In PV
Chapter -2 Expedited Reporting Criteria
Chapter -3 PSUR & PBRER
Chapter – 4 PV Database And Signal Detection
Chapter – 5 Risk Assessments & Managements

Section – 5 Medical Dictionary For Regulatory Activities medDRA
Chapter – 1 medDRA

Section – 6 PV laws And Guideline
Chapter – 1 Regulatory Guideline @ Laws In PV
Chapter – 2 SOPS In PV
Chapter – 3 PV Auditing And Inspection
Chapter – 4 Regulatory Aspects In PV

Additional information

This Global Institute of Health Science Clinical Research and Pharmacovigilance Program designed to provide total overview and skill globally in the field of clinical research. It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management. Its designed to provide total overview and skill globally in the field of clinical research and pharmacovigilance. It would help professionals to upgrade & develop their knowledge about pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance.

Post Graduate Diploma in Clinical Research and Pharmacovigilance

₹ 28,000 VAT incl.