Day Two: Wednesday, June 5, 2024 - ET (Eastern Time, GMT-05:00)
Day Two: Wednesday, June 5, 2024 - ET (Eastern Time, GMT-05:00)
- Sandra Franklin - Director, International Integrity & Compliance, Mallinckrodt Pharmaceuticals
- Gain insights from a panel of key industry stakeholders as they delve into patient engagement and its intersection with the compliance function
- Develop a deeper understanding of the ethical and compliance frameworks and code considerations surrounding the patient engagement function, including key considerations from various stakeholders and best practices in maintaining compliant partnerships
- Lama Abi Khaled - Executive Director, Ethics, Legal & Regulatory, Innovative Medicines Canada
- Stacey Silverberg - Lead, Stakeholder Engagement, Strategic Access, Advocacy and Stakeholder Engagement, J&J Innovative Medicine
- Connie Côté - Chief Executive Officer, Health Charities Coalition of Canada
- Suzanne Senior-Mitchell - Director, Ethics & Compliance, Novo Nordisk Canada Inc.
Engage in live, in-person polling with bio/pharmaceutical industry peers to benchmark on key challenges and current priorities.
- Joy DasGupta - North America Compliance Monitoring Manager, Legal and Compliance, GSK
- Steve Zuccarelli - Head of Legal & Compliance, Canada, Kyowa Kirin
Discuss real industry scenarios and look at how the MedTech Committee tackles these cases to gain insight into the Committee’s process through real-life examples
Review frequently asked questions regarding the MedTech Canada code to develop an in-depth understanding of the guidelines and how to align your compliance function with the code
- Stephan Ekmekjian - Co-Chair of Medtech Canada Compliance Committee, Health Care Compliance Officer, MedTech, Johnson & Johnson Canada
Engage in live, in-person polling with MedTech industry peers to benchmark on key challenges and current priorities.
Explore how data science is being incorporated into the compliance function and how strategic application of data science in the industry is evolving to enhance risk management
Discuss best practices in utilizing data science to improve compliance and in partnering with internal stakeholders to develop a robust data science strategy and roadmap
- Robert Watson (invited) - Director, Data Science - CTI, Global Operations, Johnson & Johnson
Explore how omnichannel compliance considerations have evolved as technology advances and different channels such as social media and influencers bring about new risk areas
Discuss the parameters of personal versus professional social media/messaging interactions and influencer promotion, and key considerations in preventing non-compliance
- Maria Daher Khouri - Head of Ethics and Business Integrity (EBI) Canada, Sanofi
- Renata Tasselli - Senior Health Care Compliance Manager, Johnson & Johnson Innovative Medicine Canada
Discuss key MedTech-specific privacy concerns as medical devices and technology evolve beyond current guidelines
Learn how to navigate compliance considerations to prioritize patient data privacy
Discuss general requirements for reference sites and centers of excellence from FCPA and MedTech code guidelines, and explore best practices in interpreting and fulfilling these requirements for a wide range of medical device products
Master how to navigate these requirements to optimize operations and enhance compliance through real- world examples
- Jessica Greco - Senior Manager, Health Care Compliance, Johnson & Johnson Canada Inc.
Explore key pre-launch compliance considerations and risk mitigation strategies surrounding disease awareness campaigns
Learn how to determine the balance between messaging and compliance to ensure effective campaigns
- Mod Rujiviphat, PhD - Global Ethics and Compliance Manager, AstraZeneca
- Thiago Neves - Medical Ethics Lead, AstraZeneca
Explore recent changes to prescribing rules that now allow different healthcare professionals to prescribe medication to patients and corresponding compliance concerns
Discuss if and how manufacturers are modifying compliance policies to address these new concerns, such as determining fair market value and rules of engagement with these professionals
- Steve Zuccarelli - Head of Legal & Compliance, Canada, Kyowa Kirin
- Explore innovative business models resulting from the MedTech market evolution, and how these new and more complicated product offerings such as capital equipment are changing the regulatory environment and the landscape of Medtech compliance
- Learn how to navigate these new risk areas, and discuss resultant new trends in this space
Dive into the evolving role of medical affairs in the Medtech space as the function becomes more involved in business and sales, and the resulting gray area
Discuss how to navigate this gray area with practical strategies to ensure current and future compliance
- Pasha Javadi - Senior Director, Medical Affairs, The Americas, embecta
Join forces with your peers to tackle complex compliance scenarios based on real-world industry challenges. Attendees will submit scenario suggestions prior to the conference and the top scenarios will be chosen to solve during this facilitator-led interactive session. Attendees will leave this session armed with new strategies, best practices and key takeaways through this unique, collaborative problem-solving session.
- Tara Kennedy - Senior Director, Ethics & Compliance North America, Apellis
- Derek Frueh - Senior Director, Ethics and Compliance, Astellas Pharma Canada