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.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass a final exam. Upon completion of the exam, CEU certificates will be provided.

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

Course Outline

• Module 1: Overview of Pharmacovigilance
• Module 2: Adverse Event Reporting and Regulatory Reporting Requirements
• Module 3: PV Audits and Inspections
• Module 4: Signal Management
• Module 5: Periodic Reporting and Risk Management

Who Should Attend

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

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

Indu Kayarat

Click here for complete trainer biographies

Course Length and Time

3 hours/week for 4 weeks.

Registration Fees

$1,595 by Early Bird Deadline

$1,795 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 12 hours (1.2 CEUs) of continuing education credit for full participation, including the completion of a final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-050-L99-P. Released: 6/25.  

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