PV is absolutely
crucial during the clinical research phase of drug development to ensure it is
safe for distribution, but it is also vital to continuously monitor the
drug. Post-market safety
monitoring is
the only way to get an accurate picture of a drug’s safety and ensure adverse
events are properly reported for review.
Why this course ?
Pharmacovigilance is the beating heart of pharmaceutical
production. Without it, there would be no way to assess the effectiveness of
drugs in comparison to their side effects. Pharmacovigilance, also known as PV,
is designed to protect patients and enable the dissemination of knowledge
amongst professionals to minimize the risk of adverse events.
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Course Features
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There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
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Live project based on any of the selected use cases on the above selected Domain.
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Each class will be followed by practical assignments which can be completed before the next class.
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We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
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Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.
Course Curriculum
Download
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Pharmacovigilance with Oracle Argus Database
Pharmacovigilance/ Drug Safety theory:
- History and overview of Pharmacovigilance
- Regulatory Authorities country wise
- Pharmacovigilance in India
- Spontaneous reporting
- Active pharmacovigilance
- Cohort Event Monitoring
- Adverse Events and its types
- Drug Safety in clinical trials and post marketed drugs
- Different sources of Adverse Events reporting
- Different types of AE Reporting Forms
- Expedited reporting and its timelines
- Aggregate reporting
- Different departments working on Pharmacovigilance
- Business workflow of Pharmacovigilance
- Minimum criteria for the case
- Causality assessment of the adverse event
- Expectedness assessment of the adverse event
- Seriousness assessment of the adverse event
- MedDRA and WHODD coding
- SAE narrative writing and Templates
- PBRER/PSUR and its submission timelines
- E2A-E2F Guidelines
- PADAR
- Explanation of Safety Signals, Signal Detection at UMC
- Signal publication and communicating signal
- Risk management
Practical Hands-on Training on Oracle Argus Safety Database :
Argus Console:
- PV Business process
- Introduction to Oracle Argus Safety Database
- Family, Product and License creation
- Clinical Study configuration
- Access management : Sites, users and Groups creation
- Workflow Configuration
- Case priority Configuration
- Case Numbering
- LAM case Numbering
- Field Validation
- Code list Configuration
- Field label Configuration
- Auto narrative Configuration
Argus Safety Module:
- Different icons used during the case processing and their purpose.
- Different tabs used in case processing
- Case Bookin and Data entry
- Case Processing of ICSR
- Case Triage
- Performing Validation
- Case Routing Based on workflow
- Case Quality check, Medical review
- Duplicate case check or verification
- Report Generation for Regulatory Submission
- Expedited Reports and Aggregate Reports
- Creating PSURs, CTPRs, NDA and IND reports
- Creating Case data analysis reports
- Unblinding the clinical trial cases
- Locking and unloking Case
- Follow Up for Case
- Query generation : Action Items
- Resolving queries using contact Logs
- Case Bookin in LAM and Routing to Central Safety database
- MedDRA coding and WHO DD coding
- Narrative Writing
Projects
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Projects
We will provide Real Time Case Studies on PV.
FAQ's
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Can I attend a demo session before enrollment?
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What if I miss a class ?
If you miss a class we can provide recording video for particular session or we can arrange you the back up session.
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Will I get placement Assistance ?
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Do I receive a certificate for training ?
- Once you are successfully through the course you will be awarded with Covalent's Training certificate.
- Covalent certification has industry recognition and we are the preferred training partner for many MNCs
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What support is available after the training?
Doubts clarification up to getting a job
Resume preparation
Mock interviews
Placement Assistance
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What Features do you provide?
Class Room & Online Live sessions
Real time projects
Working faculties
Lab facilities
Placement assistance
Resume preparation
Doubts clarification
Certifications
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Course Completion Certificate
- Once you are successfully through the course you will be awarded with Covalent's Training certificate.
- Covalent certification has industry recognition and we are the preferred training partner for many MNCs
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