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Best Pharmacovigilance Course in Pune
Quick Facts
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Medium of instructions
English
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Mode of learning
Self study
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Mode of Delivery
Video and Text Based
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Course and certificate fees
Fees information
₹ 23,000
certificate availability
Yes
certificate providing authority
TechnoBridge
The syllabus
Introduction to Clinical Research
Good Clinical Practice (GCP)-ICH E6
- History Development of International Regulations in Clinical Research
- Good Clinical Practices
- Ethics committee
- Investigator Responsibilities
- Sponsor Responsibilities
- Protocol and Investigator Brochure
- Essential Documents
Drug Development Process
- Overview of Drug Development
- Clinical trial phases
- BA/BE Studies
- Drug Development Notes
- Drug Development Quiz
Safety Reporting
- Adverse Event Reporting
- Recording of Event
- Medical Management of Adverse Events
- Handling Death
- Unblinding of Drug
- Clinical Safety and Pharmacovigilance
- E2A- Clinical Safety and Data Management
- Media 436
- Naranjo Assessment
- Order and Formulate to Determine the Quantum
- SAE Reporting
- Safety Reporting- Quiz
Pharmacovigilance
- Overview of Pharmacovigilance
- History of Pharmacovigilance
- ADR Classifications
- Introduction to Aggregate Reporting
- AE_SAE Reporting Process
Articles
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