Learn about the importance of PV in the drug development process and life cycle of a therapeutic good.
Maggie Bett:Drug Safety Team Lead, Pfizer
Maggie is a highly accomplished professional with a rich background in pharmacy and pharmacovigilance. She earned her Master of Pharmacy Degree from the University of Canberra and started her career as a Community Pharmacist in Regional NSW and Sydney. Throughout her early career in the pharmaceutical industry, Maggie held various roles in medical information, sales, regulatory affairs, clinical safety, and pharmacovigilance. In 2016, she joined Pfizer's Drug Safety Department as a Senior Drug Safety Associate. Currently, as a Drug Safety Team Lead, she manages the day-to-day activities of a comprehensive Drug Safety Department. Maggie is dedicated to empowering and mentoring the next generation of pharmacovigilance associates, ensuring they have the knowledge to enhance patient safety and make a positive impact on patients' lives.
Ayesha Ahmed, Drug Safety Team Lead- Australia, Pfizer
Ayesha is a Drug Safety Team Lead at Pfizer Australia. She is a pharmacist and a seasoned Pharmacovigilance professional with over 15 years of experience in industry. Throughout her career Ayesha gained invaluable experience working in diverse regulatory environments in Singapore and Australia while collaborating with local and international stakeholders to implement robust pharmacovigilance strategies. She is passionate about fostering talent and creating a collaborative, high-performance environment, all while maintaining commitment to patient safety and regulatory adherence. To help teams navigate the evolving landscape of pharmacovigilance, Ayesha leverages practical insight to bridge the gap between complex regulatory requirements and day-to-day operational strategies. With patient well-being at the forefront of every decision, Ayesha is proud to contribute to better healthcare outcomes worldwide.
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.
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
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.
Upon completion of this workshop, attendees will receive 7 CPD points.
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.
ARCS member - $805
Non-member - $1285
This workshop runs for one full day
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
"Fantastic session - really enjoyed it!" Senior Associate Quality, Alexion.
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