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Day Two: Tuesday, June 3, 2025 - ET (Eastern Time, GMT-05:00)
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Day Two: Tuesday, June 3, 2025 - ET (Eastern Time, GMT-05:00)
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Formats
9:00am - 9:10am
Chair’s Review of Day One
- Chrisoula Nikidis - Head, Ethics & Compliance Policy Shaping, Global Ethics and Compliance, Takeda
Showing 1 of 1 Streams
General Session
9:10am - 9:40am
Stay Ahead of the Curve – Assessing the Evolving Canadian Private Healthcare Landscape
- Examine how the expansion of private healthcare is driving shifts in the regulatory landscape, and explore the nuances of current federal and provincial regulations governing this area, including new prescribing rules for nurses and pharmacists
- Analyze potential ethical dilemmas and legal challenges arising from the growth of private healthcare, such as equitable access, patient safety, and conflicts of interest
- Discuss critical implications for the pharmaceutical and MedTech industry, including proactively identifying potential risk areas and strategies to adapt compliance programs to enhance risk mitigation
9:40am - 10:20am
Regulatory and Compliance Considerations for Combination Drug/Device Products
- Gain a deeper understanding of the unique regulatory challenges associated with developing and commercializing combination drug/device products in the Canadian market
- Mitigate potential compliance risks and enhance regulatory preparedness by addressing key challenges related to product development, clinical trials, and post-market surveillance
10:20am - 10:50am
Networking and Refreshment Break
Showing 1 of 1 Streams
General Session
10:50am - 11:30am
Navigating Compliant Company-Sponsored Trainings and Learning Activities
- Examine key compliance considerations for developing and conducting company-sponsored training and learning activities for healthcare professionals
- Develop a robust compliance framework for managing these programs, including establishing policies and procedures, conducting thorough needs assessments, and implementing effective controls to mitigate risks
- Tania Alexander - Director, Centre of Excellence – Medical Education, AstraZeneca Canada
11:30am - 11:35am
Transition to Breakout Rooms
Showing 2 of 2 Streams
BIO/PHARMA
MEDTECH
11:35am - 12:45pm
Mastering OLA Compliance – A Hands-On Workshop for Pharma Professionals
Join an interactive session delving into the essential elements of developing effective and compliant OLA programs. Attendees will:
- Develop a comprehensive understanding of the legal and regulatory framework governing OLAs, including key regulations, enforcement trends, and guidance documents
- Gain advanced insights and hone practical skills in OLA governance, emphasizing adherence to the latest regulations and industry best practices through industry case studies
- Enhance your ability to identify and mitigate compliance risks associated with OLA programs by working through scenarios
- Annie Bourgault - President, Integrated Pharma Services, Inc.
- Patrick Massad - Commissioner, Pharmaceutical Advertising Advisory Board (PAAB)
11:35am - 12:45pm
Key Compliance Considerations In Partnerships with Industry Stakeholders
- Develop robust compliance strategies for establishing and managing successful partnerships with hospitals, universities, and research institutions
- Ensure the ethical engagement of healthcare professionals in research activities, including in implementing effective device-specific training programs and data collection
- Learn to navigate the complexities of donations and in-kind support to research institutions
- Mitigate compliance risks through separation of clinical and commercial functions and prioritizing engaging in ethical planning committees
12:45pm - 1:45pm
Networking Luncheon
Showing 1 of 1 Streams
General Session
1:45pm - 2:15pm
Examine Modern Slavery Act Updates and Ethical Procurement
- Understand the evolving Canadian Modern Slavery Act and its specific implications for the Pharma and MedTech industries
- Develop robust due diligence strategies for third-party suppliers to minimize ethical and reputational risks
- Learn how to integrate Responsible Business Conduct principles into procurement processes to ensure compliance and ethical sourcing
- Elizabeth Gill - Vice President, Global Business Ethics and Compliance, Apotex Inc.
2:15pm - 3:00pm
Utilize AI to Enhance Oversight, Efficiency and Risk Mitigation
- Discuss how AI can and is being used to improve efficiency, enhance governance, and proactively mitigate risks
- Review the ethical, data privacy, and other key considerations associated with emerging AI technologies and the implementation of AI in compliance functions, and explore strategies for addressing challenges
- Discuss relevant regulatory frameworks and good governance considerations for the use of AI, the compliance officer's role in overseeing these standards, and how to encourage organizational compliance with internal policies around AI
- Dana Siddle - Partner and Health Industry Group Co-Lead, McCarthy Tétrault LLP
- Marissa Caldwell - Associate, McCarthy Tétrault LLP
Showing 1 of 1 Streams
Power Hour – Interactive Roundtable Discussions
3:00pm - 4:00pm
Power Hour – Interactive Roundtable Discussions
This session brings attendees together to unpack the biggest ideas, dive deeper into hot topics and explore the “what about” questions that didn’t get answered throughout the event. This is a unique chance to bring forward any topics you wished had been explored further and dive deeper into the questions still on your mind. Come ready to collaborate, connect and leave inspired by the collective wisdom of the group.
- Danielle Lavallee - Head, Legal & Compliance, Philips Canada
- Burcu Ergün, LL.M. - Director, Compliance, Stryker Canada
4:00pm - 4:05pm
Chair's Closing Remarks and Close of Conference
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