Overview

In this comprehensive training course learn contemporary principles, regulatory expectations, and practical approaches to drug safety and pharmacovigilance in key regulatory jurisdictions, with a focus on the US and EU. The course curriculum is designed for the basic to intermediate level professional, and the topics will span the lifecycle of traditional innovative medicinal products, from first-in-human through the post-marketing phase. This blended learning course employs a mixture of pre-course online learning, informative instructional sessions, real-world case studies, and hands-on interactive exercises where learners can apply what they learn.

Can't attend this course? Join us in Boston in August or Philadelphia in October!

What you will learn

Legal and regulatory basis for safety obligations, including a historical perspective
Principles, basic definitions, and pragmatic approaches for compliance
Basics of Individual Case Safety Reports (ICSRs) and periodic reports (DSUR, IND AR, PADER, PSUR/PBRER) in the pre-marketing, peri-approval, and post-marketing continuum
Evaluation of seriousness, expectedness, and causality
Data collection, processing, and requirements in the post-marketing phase, including MedDRA coding, safety query development, and evolving regulatory requirements
Overview of case processing and organization of a typical safety department
Safety audits and inspections
Introduction to signal detection
Introduction to benefit-risk assessment
Basics of risk management planning, EU Risk Management Plans, and Risk Evaluation and Mitigation Strategies (REMS)

Who should attend?

This program is designed for entry through intermediate level professionals involved in:

Drug safety/pharmacovigilance
Adverse event reporting
Case processing
Safety evaluation
Periodic safety reporting
Medical monitoring
Quality systems
Regulatory strategy, regulatory affairs
Risk management planning and development of formal Risk Management Plans and REMS
Disciplines that interact with or support safety and pharmacovigilance functions across the product lifecycle

Broadening their role within pre-market or post-market safety and pharmacovigilance functions

Learning objectives

At the conclusion of this activity, participants should be able to:

Identify the history, principles, and regulatory framework for clinical trials and post-marketing safety
Discuss the basic definitions of terms used in day-to-day pharmacovigilance work
Recognize basic international regulatory requirements for safety surveillance, as well as those requirements specific for the US and EU
Describe the criteria and elements of expedited and periodic reporting of drug safety information from first-in-human studies through the post-marketing phase
Demonstrate an awareness of risk management and signal detection principles

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