Course Description

This course covers the fundamentals of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. The course addresses the regulatory issues across U.S. and EU agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet U.S. and EU safety reporting standards.

Learning Objectives

• Describe regulatory requirements for product safety
• Signal detection, risk assessment and management functions
• Define how to collect, assess, report, and analyze adverse events
• Demonstrate the importance of good adverse event data collection in identifying signals
• Signaling analyses based on FDA Good Pharmacovigilance Practices
• Introduce FDA Good Pharmacovigilance Practices and EMA Good Pharmacovigilance (GVP) Modules and their relevance to Aggregate Reporting, Risk Management, and Signal Detection
• Identify differences between U.S. and European regulatory requirements

Who Should Attend

• Drug Safety and Pharmacovigilance Professionals
• Regulatory Affairs Professionals
• Senior Level Executives
• Clinical Development Staff

Instructor

The course will be led by one of the following instructors:

Indu Kayarat

Click here for complete trainer biographies

Course Outline

Day One

• What is Pharmacovigilance?: Definition and history; corporate pharmacovigilance; ADR system; critical elements
• What is an Adverse Event Drug Reaction?: Adverse Drug Reaction definition; sources of SADRs; types of ADRs; ADR reports to FDA/EMEA; serious ADR; unlabeled or unexpected ADR; expectedness “listed” vs. “unlisted”; severity/intensity; lack of efficacy; pharmacovigilance
• Global Regulatory References and Expectations: Global regulations addressing safety (ICH, CIOMS, FDA and EU)
• Regulatory Reporting: Expedited reporting timelines; aggregate reports and timelines

Day Two

• PV Audits and Audit Issues: Regulatory inspections; preparation, problems and issues; checklists; ADR; inspection principles; inspection results; potential regulatory actions
• Signaling: What is safety signal; safety signal generation; definition; pharmacovigilance process; risk/benefit; situations for signal detection; sources of signals; analysis and investigation of a signal; understanding safety signals; suspected signals, risk assessment
• Characteristics of a Good Case Report: How to do a narrative evaluation for follow-up; active query; investigator's brochure; safety; interim update for investigators; FDA time/report obligations; regulatory reporting and notification
• Risk Management: Understanding Risk Evaluation and Mitigation Strategy (REMS) and Risk Management Plans (RMP)

Interactive Activities

• Case Study Reviews
• Exercises in Drug Safety concepts

Registration Fees

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-056-L99-P. Released: 10/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.