Life Sciences Symposium
Tuesday, May 20
8:30 a.m.–1 p.m. EDT
100 Southgate Parkway
Morristown, NJ
Porzio’s legal team, industry leaders, and regulatory professionals presented an in-depth symposium addressing the latest legal and compliance trends in the life sciences sector.
Critical Topics Covered:
- State laws and transparency
- Data privacy
- Government investigations
- Panel discussion of evolving compliance requirements
This program has been approved by the Board on Continuing Legal Education of the Supreme Court of New Jersey for 2.8 hours of total CLE credit. Of these, 0 qualify as hours of total credit for ethics, professionalism, and professional responsibility, of which 0 qualify as hours of credit for diversity, inclusion, and elimination of bias (BCLE Reg. 302:1).
If you have any questions, please contact events@pbnlaw.com.
Meet Our Featured Organization
Life Science Cares mobilizes the life sciences industry to fight poverty and create opportunities for underserved communities. We do this by partnering with high-impact nonprofits focused on education, economic sustainability, and basic needs. Our support goes beyond financial grants—we connect companies and their employees with meaningful ways to get involved through volunteerism, donated goods, strategic support, mentorship, and advocacy. Beyond our philanthropic work, we also provide networking and engagement opportunities for life sciences professionals across both NJ and NYC, including lunch-and-learns, happy hours, and industry gatherings throughout the year. Visit our website to learn more.
Life Sciences Symposium
Tuesday, May 20
8:30 a.m.–1 p.m.
100 Southgate Parkway
Morristown, NJ
Porzio’s legal team, industry leaders, and regulatory professionals presented an in-depth symposium addressing the latest legal and compliance trends in the life sciences sector.
Critical Topics Covered:
- Price transparency
- Data privacy
- Government investigations
- Evolving compliance requirements
This program is pending approval by the Board on Continuing Legal Education of the Supreme Court of New Jersey for 2.8 hours of total CLE credit. Of these, 0 qualify as hours of total credit for ethics, professionalism, and professional responsibility, of which 0 qualify as hours of credit for diversity, inclusion, and elimination of bias (BCLE Reg. 302:1).
If you have any questions, please contact events@pbnlaw.com.
Meet Our Featured Organization
Life Science Cares mobilizes the life sciences industry to fight poverty and create opportunities for underserved communities. We do this by partnering with high-impact nonprofits focused on education, economic sustainability, and basic needs. Our support goes beyond financial grants—we connect companies and their employees with meaningful ways to get involved through volunteerism, donated goods, strategic support, mentorship, and advocacy. Beyond our philanthropic work, we also provide networking and engagement opportunities for life sciences professionals across both NJ and NYC, including lunch-and-learns, happy hours, and industry gatherings throughout the year. Visit our website to learn more.
Agenda
8:30 a.m.
Registration & Breakfast
9 a.m.
Welcome Remarks
Jennifer A. Romanski, Principal, Porzio, Bromberg & Newman, P.C.
9:15 a.m.
State of the State(s): State Transparency and Compliance Considerations
Sara R. Simon, Counsel, Porzio, Bromberg & Newman, P.C.
Grant Ostlund, Senior Director, Strategy & Operations - Ethics & Compliance, Novo Nordisk
Compliance with state laws continues to be a priority for life sciences companies. These laws are evolving both in scope and breadth as the government continues its focus on fraud and abuse and widens its purview into manufacturer activity. This session will explore currently active laws, relevant timelines and deadlines, and pointers for managing a complex web of potentially applicable state laws, and will focus on topics including:
- Drug Price Transparency Reporting Laws, Including the Advent of Prescription Drug Affordability Boards
- HCP Spend Transparency Reporting Laws
- Representative Registration and Reporting Laws and Other State Compliance Requirements
- Marketing Laws and Requirements
9:45 a.m.
Balancing Innovation and Compliance in the Data Privacy Matrix
Alfred R. Brunetti, Principal, Porzio, Bromberg & Newman, P.C.
Life sciences sits at the intersection of groundbreaking innovation and increasingly complex regulatory obligations. Companies must understand—and leverage—this dynamic to achieve critical patient and business goals. This session will address some of today’s most pressing data privacy concerns and explore ways to drive innovation within a complex compliance landscape.
10:15 a.m.
Break
10:30 a.m.
Navigating Investigations in Life Sciences
Martin J. Healy, Principal, Porzio, Bromberg & Newman, P.C.
In the complex and highly regulated field of life sciences, conducting thorough and compliant investigations is crucial. This session will delve into the intricacies of managing investigations within the life sciences sector. Attendees will gain insights into best practices for conducting internal investigations, navigating legal requirements and ensuring compliance with industry standards. Speakers will share real-world experience and practical strategies to help organizations mitigate risks and maintain integrity throughout the investigative process.
11 a.m.
Pharma and Med Device Compliance Panel
Jennifer A. Romanski, Principal, Porzio, Bromberg & Newman, P.C.
Jeffrey Kawalek, Chief Compliance Officer, Zambon US
Gil Rodriguera, Sr. Director, Compliance Business Partner, Mallinckrodt
Daniel Spicehandler, VP, Compliance, Commercial Divisions, Stryker
Join us for a dynamic and engaging panel of seasoned compliance professionals from the pharmaceutical and medical device industries. This interactive discussion will explore best practices for maintaining compliance and strategies for mitigating risks in an increasingly complex environment. Panelists to address:
- Scope of compliance (purview within an organization and ways to effectuate compliance)
- Keeping your compliance committee and board current
- Ongoing risk assessment and monitoring
Come prepared with your questions and challenges and gain valuable perspectives from leaders shaping the future of compliance in life sciences.
11:50 a.m.
Closing Remarks
Vito A. Gagliardi, Jr., Managing Principal, Porzio, Bromberg & Newman, P.C.
Noon – 1 p.m.
Networking Lunch
Agenda
8:30 a.m.
Registration & Breakfast
9 a.m.
Welcome Remarks
9:15 a.m.
State of the State(s): State Transparency and Compliance Considerations
Compliance with state laws continues to be a priority for life sciences companies. These laws are evolving both in scope and breadth as the government continues its focus on fraud and abuse and widens its purview into manufacturer activity. This session will explore currently active laws, relevant timelines and deadlines, and pointers for managing a complex web of potentially applicable state laws, and will focus on topics including:
- Drug Price Transparency Reporting Laws, Including the Advent of Prescription Drug Affordability Boards
- HCP Spend Transparency Reporting Laws
- Representative Registration and Reporting Laws and Other State Compliance Requirements
- Marketing Laws and Requirements
9:45 a.m.
Balancing Innovation and Compliance in the Data Privacy Matrix
Life sciences sits at the intersection of groundbreaking innovation and increasingly complex regulatory obligations. Companies must understand—and leverage—this dynamic to achieve critical patient and business goals. This session will address some of today’s most pressing data privacy concerns and explore ways to drive innovation within a complex compliance landscape.
10:15 a.m.
Break
10:30 a.m.
Navigating Investigations in Life Sciences
In the complex and highly regulated field of life sciences, conducting thorough and compliant investigations is crucial. This session will delve into the intricacies of managing investigations within the life sciences sector. Attendees will gain insights into best practices for conducting internal investigations, navigating legal requirements and ensuring compliance with industry standards. Speakers will share real-world experience and practical strategies to help organizations mitigate risks and maintain integrity throughout the investigative process.
11 a.m.
Pharma and Med Device Compliance Panel
Join us for a dynamic and engaging panel of seasoned compliance professionals from the pharmaceutical and medical device industries. This interactive discussion will explore best practices for maintaining compliance and strategies for mitigating risks in an increasingly complex environment. Panelists to address:
- Scope of compliance (purview within an organization and ways to effectuate compliance)
- Keeping your compliance committee and board current
- Ongoing risk assessment and monitoring
Come prepared with your questions and challenges and gain valuable perspectives from leaders shaping the future of compliance in life sciences.
