An Introduction to Pharmacovigilance: A Theoretical Approach

Learn about the importance of PV in the drug development process and life cycle of a therapeutic good.

Workshop overview

Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines. When Hippocrates in 500BC stated ’PRIMUM NON NOCERE’ or ’First, do no harm’ he could not have envisaged the central role that pharmacovigilance would have in assisting physicians meet this cornerstone of medicine.

This workshop will provide delegates with an understanding of the importance of the role of pharmacovigilance in the drug development process and life cycle of a therapeutic good.

The workshop analyses the role of pharmacovigilance throughout the product lifecycle. It explores the legislative and corporate governance requirements that are essential to the function. Key processes for the management of adverse events are reviewed, in clinical trials and the post approval environment. Attendees will learn how application of the science behind pharmacovigilance in the safety management of a product can minimise risks and meet our primary goal of preventing harm to the patient.

Who should attend

This workshop is for professionals who are new to the pharmaceutical industry or to a PV role and need to understand the role of pharmacovigilance within the drug development process. It is anticipated that individuals from a variety of functional areas including drug safety, regulatory affairs, medical information, quality assurance and clinical research will benefit from attending this workshop.

Workshop highlights

• Locally developed, Australian-specific content, continually updated as PV requirements evolve
• Highly experienced facilitators, currently employed in relevant pharmacovigilance roles
• Case study driven activity-based learning

Learning objectives

By the end of this course, you should be able to describe and understand:

• What PV is, and how the modern day industry is shaped by the events of the past
• Key concepts, terms and definitions used in PV
• How the risk benefit profile of a product develops and changes over its entire lifecycle
• The cross-functional role of PV and how it interfaces with internal and external stakeholders
• Key processes of a PV system and the role it plays in minimising harm to patients
• The key Australian and international legislative framework for PV that forms the basis of company standard operating procedures
• Potential sources of adverse events (AEs) and how they are collected, documented, assessed, processed, reported and submitted to regulators
• How data collected are used to update the reference safety information

Note: This workshop will focus on pharmaceuticals. Differences in reporting for medical devices, biologicals and vaccines will be highlighted throughout the session.

Continuing Professional Development (CPD) points

Upon completion of this workshop, attendees will receive 7 CPD points.

Entry criteria

This is an entry level/introductory workshop. There are no entry criteria for this workshop. If you have any questions on your suitability for this workshop, do not hesitate to call the ARCS Business Office (02) 8905 0829.

Registration fees

Workshop fees (incl. GST):
Early bird – until 24 Jul
ARCS Member – $540
Non-member – $885

Standard – from 25 Jul
ARCS Member – $710
Non-member – $1140

Please note that virtual workshops at ARCS cover the same content as the physical (face-to-face) workshop. The training material, exercises and student workbook have been redesigned to ensure that the same learning outcomes are achieved as traditional workshops.

The registration fees for virtual workshops have been reduced by $150 per person, per workshop day to reflect the reduction in venue and catering costs associated with a face-to-face workshop.

Virtual classroom

This workshop runs for one full day from 09:00-17:00

Attendee requirements:

• Computer/laptop connected to power
• Good internet access (1Mbps or better – broadband recommended)
• A charged mobile phone and headphones (if using your phone for audio)
• Phone charger – given the event goes all day, you will need a way of charging your phone
• Headphones for computer audio (if using computer audio)
• A quiet room/space
• Before joining, be sure to check system requirements to avoid any connection issues

Testimonials

“Fantastic session – really enjoyed it!”  Senior Associate Quality, Alexion.

Find out more and register to attend.