Screening and Management of Literature for Pharmacovigilance Activities

Clinical trials can only show results of applying medication or therapeutic devices to members of a controlled population usually in controlled settings. However, once the product is approved for commercialization, variation of some sort is bound to exist in how different people accommodate it. Hence, pharmacovigilance is a necessary extension of the drug discovery process where the use of a novel drug or device is monitored in the real world. This course introduces students to the various reports used in compiling data for active and passive pharmacovigilance and points out the relevance of agencies like the FDA and MHRA in collating such information.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

• Objectives of Pharmacovigilance

Lesson 1: Screening Scientific Literature for Pharmacovigilance Purposes

• Role of Scientific and Medical Literature in Pharmacovigilance
• Passive Surveillance (Pharmacovigilance)
• Spontaneous Reporting of Adverse Drug Reactions
• Identification of Safety Signals for Spontaneous Reporting
• Case Series Reports
• Causality Assessment

Lesson 2: Summary Reports

• Periodic Safety Update Reports
• The Value of Periodic Safety Update Reports
• Periodic Benefit-Risk Evaluation Report
• The Periodic Benefit-Risk Evaluation Report Utility
• The Risk Management Plan
• The Risk Minimization Activities
• Pharmacovigilance Specifications
• Usefulness of Risk Management Plan
• Development Safety Update Report
• The Usefulness of the Development Safety Update Report

Lesson 3: Active Surveillance (Pharmacovigilance)

• Patient Registries
• Pharmacovigilance Activities
• Conceptual Approach – Key Areas for Measuring the Impact of Pharmacovigilance Activities

Lesson 4: Effectiveness of Risk Minimization Activities

• Effectiveness of Specific Pharmacovigilance Processes
• Enablers of Effectiveness in Pharmacovigilance
• Identification and Development of Analytical Methods
• Why Screen Medical Literature to Identify Single Adverse Drug Reactions?
• Why Search the Literature?
• Literature as a Source of ADRs: Thalidomide and Congenital Birth Defects
• Challenges with Screening Scientific and Medical Literature for Pharmacovigilance

Lesson 5: Difference in Regulation

• Building the Perfect Search Strategy
• The Large Volume of Scientific Literature
• Inspections and Audits
• Monitoring Local Language Journals
• Implementing EMA MLM Results
• The Argument for Outsourcing
• Outsourcing Is Not Without Its Risks

Lesson 6: Software Solutions for Literature Management

• Literature Management Solution: Improve Workflow Management and Regulatory Compliance
• Online Information Management Solution
• What Does QUOSA Do?
• Who is QUOSA for?
• Why Choose QUOSA?
• How Does QUOSA Work?

Conclusion

Acronyms

Glossary

Quiz