Best Pharmacovigilance Course in Pune

BY
TechnoBridge

Mode

Online

Duration

2 Months

Quick Facts

particular details
Medium of instructions English
Mode of learning Self study
Mode of Delivery Video and Text Based

Course and certificate fees

certificate availability

Yes

certificate providing authority

TechnoBridge

The syllabus

Introduction to Clinical Research

  • Introduction to Clinical Research
  • Terminologies in Clinical Research
  • Advantages of CR in India
  • Introduction to Clinical Research- Notes
  • Introduction to Clinical Research Quiz

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

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