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Certificate Program In
Clinical Research & Pharmacovigilance
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Introduction To Clinical Research.
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Basic Pharmacology & Pharmacy in Clinical Research
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New Drug Development Process
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Ethics in Clinical Research
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Regulations in Clinical Research (Good Clinical Practice, Schedule Y)
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Clinical Research Documentation
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Quality in Clinical Research Study
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Clinical Trial Management- Essential Documents
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Introduction to Pharmacovigilance
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Pharmacovigilance Reporting Techniques-Adverse Drug Reaction/Event
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Expedited Reporting
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Causality Assessment- (WHO)
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Individual Case Safety Report (ICSR)
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Periodic Safety Update Report (PSUR)
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Post Marketing Surveillance (PMS)
Program Duration/Assessment/Eligibility
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3 months / 6 Months
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6 Modules
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On finishing each module 1 assignment & one exam
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BioScience /Life Science / Nutrition Pharmacy / Medical / Nursing Graduates and Postgraduates
Application Process
Fiill out the form below, and WhatsApp at +91 9231739412 your ID and degree mark sheet/Certificate , Once submitted one of our research consultant will contact you to proceed with the further steps.
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Introduction to New Drug Development Process
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Regulations in Clinical Research (Good Clinical Practice, Schedule Y)
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Clinical Research Documentation
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Essential Clinical Trial Documents
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Introduction to Pharmacovigilance
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Pharmacovigilance Reporting Techniques-Adverse Drug Reaction/Event
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Expedited Reporting
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Causality Assessment
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Individual Case Safety Report (ICSR)
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Periodic Safety Update Report (PSUR)
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Post Marketing Surveillance (PMS)
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Clinical Data Management-Introduction
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Clinical Data Management Standards- 21CFR11
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Clinical Data Management -Process & Methodology
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Clinical Data Management Quality Assurance & Control
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Query Management Cycle
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Electronic Data Capture System [EDC]
Program Duration/Assessment/Eligibility
Application Process
Fiill out the form below, and WhatsApp at +91 9231739412 your ID and degree mark sheet/Certificate Once submitted one of our research consultant will contact you to proceed with the further steps.
Certificate Program In
Medical Writing & Regulatory Affairs
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Introduction to New Drug Development Process
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Regulations in Clinical Research (Good Clinical Practice, Schedule Y)
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Essential Clinical Trial Documents
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Introduction to Pharmacovigilance
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Pharmacovigilance Reporting Techniques-Adverse Drug Reaction/Event
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Expedited Reporting-ICH E2A
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Individual Case Safety Report (ICSR)- ICH E2B
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Periodic Safety Update Report (PSUR)
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Narrative Writing
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Global Regulatory Affairs- USFDA, EMA,WHO & ICH
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Medical Device Regulatory Submissions-510K
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IND & NDA preparation
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Protocol Development
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Inform Consent Form Preparation
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Case Report Form(CRF) Development
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Development of Investigator undertakings
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Preparation of Product information documents - IB, Monograph, package inserts etc.
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Preparation of Clinical Study Report (CSR)
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6 Months /3 months
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6 Modules
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On finishing each module 1 assignment & one exam
-
BioScience /Life Science / Nutrition Pharmacy / Medical / Nursing Graduates and Postgraduates
Program Duration/Assessment/Eligibility
Application Process
Fiill out the form below, and WhatsApp at +91 9231739412 your ID and degree mark sheet/Certificate, Once submitted one of our research consultant will contact you to proceed with the further steps.
-
6 Months
-
6 Modules
-
On finishing each module 1 assignment & one exam
-
BioScience /Life Science / Nutrition Pharmacy / Medical / Nursing Graduates and Postgraduates
Certificate Program In
Clinical Data Management & Pharmacovigilance
-
6 months/ 3 Months
-
6 Modules
-
On finishing each module 1 assignment & one exam
-
BioScience /Life Science / Nutrition Pharmacy / Medical / Nursing Graduates and Postgraduates