Diploma in Pharmacovigilance & Regulatory Affairs

$899.00

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Description

 

The Advanced Diploma in Pharmacovigilance & Regulatory Affairs (ADPV-RA) is an e-learning program designed to provide students a complete understanding of Pharmacovigilance processes, regulations and documentation as well as the pharmaceutical regulatory affairs landscape. It equips you to start a career in Drug Safety or as a Regulatory Affairs specialist. The course is aligned to the requirements of the industry and includes hands-on training modules on Oracle Argus Safety for Pharmacovigilance.

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

Curriculum

Course Stats – 26 Modules, 116 Chapters, 113 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 – 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 4 – 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 5 – 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 6 – Global Pharmacovigilance and Safety Standards
  • WHO & Safety Reporting
  • CIOMS Groups & Functions
  • Good Pharmacovigilance Practice
Module 7 – 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 8 – 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 9 – 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 10 – Introduction to the Judicial System in India
  • Introduction to Medical Ethics, Medical Malpractice
  • Overview of Judicial System in India
  • Legitimacy and Paternity
  • Privileged Communication and Professional Secrets
Module 11 – Drugs and Cosmetic Act and Rules
  • Introduction, Aims and Objectives, Definitions
  • Schedules to Drug Rules
  • Import, Manufacture and Sale of Drugs
  • Labeling and Packaging of Drugs
Module 12 – Schedule Y
  • Introduction, Amendments to Schedule Y
  • Clinical Trials
  • Studies in Special Population, Post Marketing Surveillance and Special Studies
  • Appendices
Module 13 – Indian Regulations Governing Clinical Trials
  • Regulatory Authorities in India
  • Guidelines and important provisions
  • Indian Regulatory Approval Process and approval timelines
Module 14 – Regulatory Regime in US
  • Responsibilities of US FDA
  • FDA Centers
  • Code of Federal Regulations
  • FDA guidelines for industry
Module 15 – European Medicines Agency (EMEA)
  • Introduction, Roles and Responsibilities of EMEA
  • Committees of EMEA
  • EU Clinical Directives
  • EUDRA CT
Module 16 – Regulations in Japan
  • Organization and Function of MHLW (JAPAN)
  • Pharmaceutical Laws and Regulations in Japan
  • Drug Development in Japan
Module 17 – In-Vitro and In-Vivo Pre-clinical studies
  • ICH Safety Guidelines related to Carcinogenicity, Genotoxicity, Reprotoxicity
  • ICH safety guidelines related to pharmacology and immunotoxicology studies
Module 18 – Efficacy Topics related to Clinical Studies
  • Clinical Safety
  • Dose Response Studies
  • Clinical Evaluation
Module 19 – Common Technical Document (CTD)
  • General principles of CTD
  • Modules with Diagrammatic representation
  • eCTD
Module 20 – IND and NDA Requirements
  • IND and NDA applications in U.S
  • IND and NDA Applications in India
Module 21 – CMC Information
  • CMC for Phase I
  • CMC for Phase II and III
Module 22 – Overview of GHTF
  • Organization
  • Study Groups and Documents
Module 23 – Regulatory Processes for Medical Devices and Veterinary Products
  • U.S Scenario
  • Indian Scenario
Module 24 – Biosimilars EMEA Guidance and Regulations
  • Guidelines and Applications of Biosimilars
  • Specific Guidelines
Module 25 – Biopharmaceutical Indian Regulations and Guidelines
  • Regulatory Bodies
  • Guidelines for Pre-Clinical and Clinical studies
Module 26 – Regulatory Strategic Planning, Interfacing and Corporate Communications
  • Regulatory Strategic Planning
  • Corporate Communications
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, and Argus Safety software for the duration of the program.

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