Diploma in Pharmacovigilance & Data Management

$899.00

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Description

 

The Advanced Diploma in Pharmacovigilance & Data Management (ADPV-DM) is an e-learning program designed to provide students a complete understanding of Pharmacovigilance and Clinical Data management processes, regulations and documentation. It equips you to start a career in Drug Safety or as a Clinical Data Management 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 Clinical for Clinical Data Management.

This course provides 24×7 access to the Oracle Argus Safety as well as Oracle Clinical 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 Clinical software
  • Course Instructor support via Discussion Forums

Curriculum

Course Stats – 14 Modules, 125 Chapters, 121 Quizzes

 

Module 1 – General Introduction
  • Pharmaceutical & CR – 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 – Epedemiology and Evidence Based Medicine (EBM)
  • Epidemiology 1 – Introduction
  • Epidemiology 2 – Concept of Causation
  • Epidemiology 3 – Epedemiological Study Designs
  • Epidemiology 4 – Statistics
  • Evidence Based Medicine
Module 3 – Pharmaceutical Medicine
  • Introduction to Pharmaceutical Medicine
  • Pre-clinical Development of Drugs and Biologics
  • Clinical Phases of Drug development
  • General Pharmacology
  • BA-BE Studies
  • Pharmacogenetics-Pharmacogenomics
  • Toxicology
  • Systemic Pharmacology
  • Clinical Trial Design
  • Intellectual Property Rights
  • Personalized Medicine
  • Clinical Trials in Pediatrics
  • Drug Safety in Pregnancy
  • Research Methods for Genetics Studies
  • Stem Cell Research and its Applications
  • Endpoints in Clinical Trials
  • Clinical Trial Registries
Module 4 – 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 5 – 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 6 – 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 7 – Global Pharmacovigilance and Safety Standards
  • WHO & Safety Reporting
  • CIOMS Groups & Functions
  • Good Pharmacovigilance Practice
Module 8 – 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 9 – 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 10 – Oracle Argus Safety Essentials
  • Overview and Navigation
  • Business Process Workflow
  • Case Entry and Processing
  • Case Form Features
  • Coding Terms and MedDRA browser
  • Advanced Conditions
  • Dashboards and Utilities
  • Reporting and Submissions
Module 11 – Basics of Clinical Data Management
  • Introduction to Clinical Data Management
  • Application of Computers in Pharmaceutical Research & Development
  • Data Management Plan
  • Case Report Form Design
  • Patient Registration
  • Clinical Data Acquisition
  • Clinical Data Definition and Database Design
  • Training, Education, and Documentation Requirements
  • Safety Data Management
  • CDM Documentation Overview
Module 12 – Clinical Data Management Processes and Standards
  • Data Entry Methods and Processes
  • Database Validation and Standards
  • Database Closure
  • Clinical Data Management Audits
  • Measuring Performance in CDM
  • Data Validation and Query Management
  • Process of Drug Development
  • Clinical Data Management Process
  • Standard Operating Procedures
Module 13 – Clinical Data Management Systems
  • Clinical Data Management Systems
  • Database Migration and Archival
  • Medical Coding Dictionaries and MedDRA
  • Software Tools used in Management of Clinical Trials
  • Laboratory Data
  • Receipt and Review of Data
  • Data Presentation
  • Oracle Pharmaceutical Application Suite
Module 14 – Oracle Clinical Fundamentals
  • Oracle Clinical Navigation
  • Oracle Clinical Overview
  • Oracle Clinical – Planning a study
  • Oracle Clinical – Designing a study
  • Oracle Clinical – Global Library (DVGs, Questions, Question Groups)
  • Oracle Clinical – Definition subsystem (DCMs, DCIs, Layouts)
  • Oracle Clinical – Validation and Derivation Procedures
  • Oracle Clinical – Data Entry
  • Oracle Clinical – Discrepancy and DCF Management
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 Clinical software for the duration of the program.

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