Introduction to Pharmacovigilance (PV)

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. Pharmacovigilance aims to ensure the safe and effective use of medicines by healthcare professionals and patients while minimising risks and maximising benefits.

The Introduction to Pharmacovigilance (PV) course provides comprehensive training on the principles, processes, and importance of pharmacovigilance in drug development and post-marketing surveillance. Participants will gain a solid understanding of pharmacovigilance terminology, regulatory requirements, and best practices for ensuring the safety of medicinal products.

Key Learning Objectives

• Understand the concept and scope of pharmacovigilance, including its role in drug safety monitoring throughout the lifecycle of medicinal products.
• Familiarise 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 minimize 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

The course is delivered through a combination of online lectures, instructor-led case studies, live group discussions, and interactive activities, spanning approximately 70 hours.

The lectures, exams, and supplementary materials are structured to be finished at your own pace. The practical masterclasses are conducted in real-time and have set schedules. For the most up-to-date information regarding masterclass schedules for this course, please reach out to us directly at info@clueoclinical.com. You’ll have up to 6 months from the onboarding date to finish all aspects of the course.

Target Audience

This course is ideal for:

• Professionals working in the pharmaceutical and biotechnology industries involved in drug development, regulatory affairs, clinical research, and drug safety.
• Healthcare professionals, such as physicians, pharmacists, nurses, and medical researchers, interested in expanding their knowledge of pharmacovigilance principles and practices.
• Regulatory affairs professionals responsible for ensuring compliance with pharmacovigilance regulations and guidelines.
• Clinical research professionals, including clinical research associates (CRAs), clinical trial coordinators, and data managers, involved in clinical trials and post-marketing surveillance.
• Quality assurance professionals responsible for monitoring and auditing pharmacovigilance processes and systems.
• Students and graduates pursuing degrees or certifications in pharmaceutical sciences, pharmacology, clinical research, regulatory affairs, or related fields seeking foundational knowledge in pharmacovigilance.
• Individuals interested in transitioning to a career in pharmacovigilance or drug safety monitoring roles within the pharmaceutical industry or regulatory agencies.

Prerequisite

Having prior knowledge of ICH-GCP guidelines and the regulatory framework governing clinical trials is beneficial as it enables you to apply the knowledge and skills obtained through this course effectively.