APGDCR-PAdvanced PG Diploma in Clinical Research & Pharmacovigilance
Study location | Online |
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Type | Advanced PG Diploma, e-learning |
Nominal duration | 12 months (60 ECTS) |
Study language | English |
Awards | APGDCR-P (Advanced Postgraduate Diploma in Clinical Research & Pharmacovigilance) |
Accreditation | Certified by Swiss EduQua via certificate no CH20/0771 |
Tuition fee | €2,200 one-time Payments can be made in full; or |
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Entry qualification | Bachelor's degree (or equivalent / higher) A bachelor’s degree or equivalent preferably in any life sciences related domain. If you are not sure about your eligibility, please contact our admissions counselors. |
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Language requirements | English |
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More information |
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Overview
Mode of Learning: ONLINE
Duration: About 12 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
This Advanced Pharmacovigilance Training Course is an integrated program that will give you a methodical understanding of the key areas of drug development, clinical research processes, clinical trial management, and pharmacovigilance systems thus boosting your skills and knowledge to the level expected of a Clinical Research and Pharmacovigilance Professional. In addition to clinical trial management, this Advanced Pharmacovigilance Training Program trains students to put together, evaluate and organize data related to drug side effects so as to make regulatory decisions pertaining to marketed drugs. Both clinical research and pharmacovigilance are now generating a significant number of new exciting career opportunities.
Programme structure
Module 01: General Introduction
Module 02: Epidemiology & Evidence-Based Medicine
Module 03: Pharmaceutical Medicine
Module 04: Therapeutic Areas
Module 05: Ethics In Clinical Research
Module 06: Roles And Responsibilities
Module 07: Clinical Trial Preparation
Module 08: Essential Documents And Regulatory Submission
Module 09: Study Start-Up
Module 10: Clinical Trials Monitoring
Module 11: Compliance And Audits
Module 12: Data Management And Biostatistics
Module 13: Regulatory Affairs In Clinical Research
Module 14: Medical Device Trials
Module 15: Project And Vendor Management
Module 16: Financial Management Of Clinical Trials
Module 17: Personality Development And Communication Skills
Module 18: Principles Of Pharmacovigilance
Module 19: Pharmacovigilance And Selected System Organ Classes
Module 20: Pharmacovigilance Systems
Module 21: Global Pharmacovigilance And Safety Standards
Module 22: Pharmacovigilance Regulations And Guidelines
Module 23: Pharmacoepidemiology
Module 24: Basics of Good Medical Writing
Module 25: Quality & Quality Management
Module 26: The Quality Assurance Function
Career opportunities
This combination program of clinical research and pharmacovigilance will allow you explore career opportunities both related to clinical trials as well as those related to drug safety. Positions that can be explored include Clinical Research Associate, Clinical Research Coordinator, Drug Safety Associate, Case Processing Expert, Pharmacovigilance Executive etc.
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