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.
Looking for a course that includes 24×7 access to Oracle Argus Safety + Oracle Empirica Signal software? Check out this course
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 for the duration of the program.
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