Introduction to Pharmacovigilance (PV) for Medicinal Products

Description

Course Overview

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems associated with pharmaceutical products. It involves monitoring the safety of medicines before and after they enter the market, collecting and analysing information on adverse drug reactions (ADRs), evaluating risks and benefits, and taking necessary regulatory actions to protect public health. Effective drug safety monitoring is critical to ensuring that trials adhere to ethical standards and regulatory requirements. Mastering pharmacovigilance can make you an indispensable asset in medicinal clinical trials, helping to mitigate risks and ensure regulatory compliance.

The Introduction to Pharmacovigilance (PV) for Medicinal Products course is designed for individuals seeking to understand the fundamentals of drug safety monitoring for medicinal products, from identifying and reporting adverse events to complying with global drug safety regulations. Whether you’re new to the field or looking to strengthen your expertise, this course equips you with the knowledge and tools to prioritise patient safety and support successful trial outcomes.

Key Learning Objectives

• Understand the concept and scope of pharmacovigilance, including its role in drug safety monitoring throughout the lifecycle of medicinal products.
• Familiarise yourself with pharmacovigilance terminology, including key terms and definitions used in adverse event reporting and risk management.
• Gain insight into the regulatory requirements and guidelines governing pharmacovigilance practices, both internationally and locally.
• Learn the fundamentals of adverse drug reaction (ADR) identification, classification, documentation, and reporting.
• Understand the processes and systems involved in pharmacovigilance, including spontaneous reporting systems, expedited reporting of serious adverse events, and signal detection methods.
• Explore the role of pharmacovigilance in clinical trials, including safety monitoring requirements and reporting obligations during the conduct of clinical research.
• Learn about risk management plans (RMPs), including their development, implementation, and evaluation to minimise risks associated with medicinal products.
• Understand the importance of pharmacovigilance communication and collaboration among stakeholders, including healthcare professionals, regulatory authorities, and the pharmaceutical industry.
• Develop an appreciation for the ethical and societal implications of pharmacovigilance activities and their impact on public health and patient safety.

Course Structure

This course is designed for busy professionals and is delivered through online, self-paced learning with recorded simulations that provide real-life scenarios for effective learning. The course includes:

• Interactive modules covering fundamentals of pharmacovigilance, adverse event identification and reporting, global regulatory frameworks,
• Recorded simulations and real-world case studies to apply your learning to practical scenarios.
• Quizzes and assignments to help reinforce your understanding and ensure retention of critical information.
• Final assessment to evaluate your knowledge and award certification upon successful completion.
• Downloadable Resources: Templates, checklists, and guides.
• Mode: 100% Online, Self-Paced

Duration: Approximately 18 hours

Who Should Enrol?

This course is ideal for:

• Clinical Research Associates (CRAs)
• Clinical Trial Coordinators
• Regulatory Affairs Professionals
• Drug Safety Associate
• Anyone interested in transitioning to a career in pharmacovigilance or drug safety monitoring roles within the pharmaceutical industry or regulatory agencies.

Prerequisite

• A bachelor’s degree or equivalent qualification in a relevant field (e.g., Life Sciences, Nursing, or related disciplines).
• Familiarity with basic clinical trial processes and terminology is recommended, but not mandatory.