Diploma in Pharmacovigilance & Signal Detection

$899.00

Oracle Argus Safety + Oracle Empirica Signal – software access is included.

Category:

Description

 

The Advanced Diploma in Pharmacovigilance & Signal Detection (ADPV-SD) is designed to provide students a complete understanding of Pharmacovigilance and Signal Detection processes, regulations and documentation. It equips you to start a career in Drug Safety or as a Pharmacovigilance Signal Detection professional. The course is aligned to the requirements of the industry and  includes hands-on training modules on Oracle Argus Safety for Pharmacovigilance and Oracle Empirica Signal for Signal Detection.

This course provides 24×7 access to the Oracle Argus Safety as well as Oracle Empirica Signal software for hands-on practical learning.

 

Key Features

 

  • Full access to e-Learning Portal containing Multimedia Tutorials, Recorded Lectures and Quizzes.
  • 24×7 access to Oracle Argus Safety software
  • 24×7 access to Oracle Empirica Signal software
  • Course Instructor support via Discussion Forums

Curriculum

Course Stats – 9 Modules, 73 Chapters, 72 Quizzes

 

Module 1 – Introduction to Clinical Research
  • Pharmaceutical and Clinical Research – Industry Overview
  • Introduction to Clinical Research
  • Stakeholders and Roles in Clinical Research
  • History and Milestones in Clinical Research
  • Principles of Good Clinical Practice
  • Technologies in Clinical Trial Management
  • Overview of Clinical Research Regulatory Bodies
Module 2 – Principles of Pharmacovigilance
  • General Overview of Pharmacovigilance
  • History and aim of Pharmacovigilance
  • Drug dependence
  • Vaccine Vigilance
  • Principles of Signal Detection in Pharmacovigilance
  • Communication in Pharmacovigilance
  • Post-Marketing Surveillance
Module 3 – Pharmacovigilance and Selected System Organ Classes
  • Dermatological ADRs
  • Gastrointestinal ADRs
  • Haematological ADRs
  • Renal ADRs
  • Ocular Side Effects of Prescription Medications
  • Drug Safety in Pregnancy
  • Hepatic Drug Reactions
  • Anaesthetic Adverse Drug Reactions
  • Pharmacovigilance in Pediatrics
  • The Cardiovascular Spectrum of Adverse Drug Reactions
  • Drugs and the Elderly
Module 4 – Pharmacovigilance Systems
  • Audits and Inspections in Pharmacovigilance
  • Pharmacovigilance Department
  • Qualified Person for Pharmacovigilance
  • Standard Operating Procedures in Pharmacovigilance
  • Literature Review
  • MedDRA
  • Eudravigilance
  • Assessment of Compliance
  • Mergers and Acquisitions
  • Softwares used in Pharmacovigilance
Module 5 – Global Pharmacovigilance and Safety Standards
  • WHO & Safety Reporting
  • CIOMS Groups & Functions
  • Good Pharmacovigilance Practice
Module 6 – Pharmacovigilance Regulations and Guidelines
  • Safety Reporting
  • Individual case safety reports
  • Periodic safety update reports
  • Indian Regulations with specific reference to Schedule Y
  • Regulatory Pharmacovigilance in EU
Module 7 – Pharmacoepedemiology
  • Introduction to Pharmacoepidemiology
  • Molecular Genetic Pharmacoepidemiology
  • Analysis of Pharmacoepidemiological Data
  • Studies of Drug Use
  • Case Control Studies
  • Cohort Studies
  • Data Sources
  • Measures of Frequency & Risk
  • Advanced Issues in Pharmacoepidemiology
  • Errors in Pharmacoepidemiology
Module 8 – Oracle Argus Safety Essentials
  • Overview and Navigation
  • Overview of Argus Menus
  • Case Form Features
  • Drug and Event Coding
  • Case Entry and Processing
  • Advanced Conditions
  • Reporting and Submissions
Module 9 – Oracle Empirica Signal
  • Introduction to Signal Detection
  • Introduction to Empirica Signal
  • Signal Detection and Prioritization
  • User Interface – Settings and Features
  • User Interface – Preferences
  • Navigation with Tabs
  • Queries and Case Series
  • Creating Data Mining runs
  • Data Mining Results – Graphical Display
  • Drug Profiles and Reports
  • Empirica Signal Topics
Course Completion
  • Final Assessment
  • Course Certification

Certification

 

At the end of the course, students will be awarded a certificate of completion.

Duration

 

The duration of this program is 6 months.

You will have access to the course, Argus Safety and Oracle Empirica Signal software for the duration of the program.

Reviews

There are no reviews yet.

Be the first to review “Diploma in Pharmacovigilance & Signal Detection”

Your email address will not be published. Required fields are marked *