A24. BALANCE and Consistency with the PI: Where’s the Line?
Tracks
Medical Operations
| Tuesday, June 3, 2025 |
| 4:30 PM - 5:30 PM |
| Parkside 2 |
Chair & Speakers
Sophie Seck
Medicines Australia
BALANCE and Consistency with the PI: Where’s the Line?
Abstract
Join us for an engaging, hands-on workshop exploring one of the most important – and often debated – areas: achieving balance and ensuring consistency with the Product Information (PI).
Facilitated by Deborah Monk and Sophie Seck, this interactive session will begin with a short overview of key principles, followed by small-group discussions using real-world-inspired scenarios. Each table will work through a case study designed to challenge your understanding of what makes our communication balanced, and also how do we determine consistency with the PI?
We’ll then come together to compare insights and unpack common grey areas. You’ll leave with practical tools, fresh perspectives, and a stronger understanding of how to approach compliance decisions with confidence—whether you’re engaging HCPs or non-HCP audiences.
No polling apps, no phones—just dynamic face-to-face discussion, peer learning, and direct access to Code experts. All levels of experience welcome.
Facilitated by Deborah Monk and Sophie Seck, this interactive session will begin with a short overview of key principles, followed by small-group discussions using real-world-inspired scenarios. Each table will work through a case study designed to challenge your understanding of what makes our communication balanced, and also how do we determine consistency with the PI?
We’ll then come together to compare insights and unpack common grey areas. You’ll leave with practical tools, fresh perspectives, and a stronger understanding of how to approach compliance decisions with confidence—whether you’re engaging HCPs or non-HCP audiences.
No polling apps, no phones—just dynamic face-to-face discussion, peer learning, and direct access to Code experts. All levels of experience welcome.
Biography
Sophie Seck is Senior Manager of Ethics and Compliance at Medicines Australia. Her role is to not just administer the Code of Conduct, but also to support its application throughout industry and ensure the conduct of industry in Australia remains of the highest ethical standard, so that the environment in which we provide access to our medicines is sustainable and fair. Sophie is a senior leader with over 30 years of experience across various sectors, specialising in non-governmental organisations. Throughout her career, she’s driven change and innovation through ethical leadership, strong stakeholder engagement, and a commitment to governance and compliance.
Deborah Monk
Consultant
Medicines Australia (consultant)
BALANCE and Consistency with the PI: Where’s the Line?
Abstract
Join us for an engaging, hands-on workshop exploring one of the most important – and often debated – areas: achieving balance and ensuring consistency with the Product Information (PI).
Facilitated by Deborah Monk and Sophie Seck, this interactive session will begin with a short overview of key principles, followed by small-group discussions using real-world-inspired scenarios. Each table will work through a case study designed to challenge your understanding of what makes our communication balanced, and also how do we determine consistency with the PI?
We’ll then come together to compare insights and unpack common grey areas. You’ll leave with practical tools, fresh perspectives, and a stronger understanding of how to approach compliance decisions with confidence—whether you’re engaging HCPs or non-HCP audiences.
No polling apps, no phones—just dynamic face-to-face discussion, peer learning, and direct access to Code experts. All levels of experience welcome.
Facilitated by Deborah Monk and Sophie Seck, this interactive session will begin with a short overview of key principles, followed by small-group discussions using real-world-inspired scenarios. Each table will work through a case study designed to challenge your understanding of what makes our communication balanced, and also how do we determine consistency with the PI?
We’ll then come together to compare insights and unpack common grey areas. You’ll leave with practical tools, fresh perspectives, and a stronger understanding of how to approach compliance decisions with confidence—whether you’re engaging HCPs or non-HCP audiences.
No polling apps, no phones—just dynamic face-to-face discussion, peer learning, and direct access to Code experts. All levels of experience welcome.
Biography
Deborah holds a Bachelor of Pharmacy from the University of Sydney and a Diploma in Hospital Pharmacy. She also holds a Bachelor of Arts from Macquarie University and a Masters in Public Policy from the University of Sydney
Deborah started her working life as a clinical pharmacist in the Pharmacy Department at a major teaching hospital in Sydney.
Before retiring in December 2019, Deborah had worked for Medicines Australia for more than 30 years. Her final role was Director of Ethics and Compliance and Corporate Services and Secretary to the Medicines Australia Board.
Recognising her experience in leading multiple reviews and updates to the Medicines Australia Code of Conduct, including Code Edition 19, Deborah was invited to assist Medicines Australia with the 2024 review of the Code. She has continued to assist in the development of guidance documents to support the implementation of the new Code Edition 20.
