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Compliance

Panel: Planning for the Future of Sustainability: What are the Five Big Things We Need to Talk About?
Sustainability, SUSTAINABILITY, VIDEO

Panel: Planning for the Future of Sustainability: What are the Five Big Things We Need to Talk About?

April 5, 2024

Moderator: Evan van HookChief Sustainability OfficerViridi D. Evan van Hook is Viridi’s Chief Sustainability Officer.  From 2004 to 2023 Evan was CSO of Honeywell International, leading that Company’s 93% decarbonization of its facilities and operations during that period.  He is a graduate of Yale Law School, and is both a former partner at the law firm Sidley & Austin and Assistant Commissioner of the New Jersey Department of Environmental Protection.  He has taught International Environmental Law at Columbia Law School and lectured at the United Nations ITR, and was a credentialed observer at UN FCCC COP 23, COP 24 and…

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Tackling Scope 3 and Supply Chain Sustainability at the Crossroads of New Regulations and ESG Goals
Sustainability, SUSTAINABILITY, VIDEO

Tackling Scope 3 and Supply Chain Sustainability at the Crossroads of New Regulations and ESG Goals

April 5, 2024

In this session, we will uncover some common challenges when building or scaling ESG programs, as well as best practices and approaches for measuring, reporting, and mitigating Scope 3 emissions. Join us to learn more about: Amanda ZalkSenior Strategic Account ExecutivesEcoVadis Amanda has driven sustainable behavior changes since her earliest days. With a background in carbon-emission mitigation policy and international relations, Amanda is passionate about harnessing the power of global business for positive change. Now at EcoVadis, Amanda partners with the world’s largest Financial and Legal Services organizations to leverage sustainability as a performance and value driver for procurement as…

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Conquering Complexity: Scaling ESG Reporting in the New Regulatory Landscape
Sustainability, SUSTAINABILITY, VIDEO

Conquering Complexity: Scaling ESG Reporting in the New Regulatory Landscape

April 5, 2024

ESG reporting presents a complex challenge for large organizations.  New regulations like the EU’s CSRD and the SEC’s climate disclosure rules raise the bar for transparency and accountability. Effectively managing ESG data, often spread across regions and departments, is critical to meeting these heightened expectations. Building effective ESG governance requires a strategic approach that tackles both data management and regulatory compliance as interconnected aspects of this complex challenge.In this session, you will: Nicole PeerlessHead of Business EngagementPulsora Inc. Nicole Peerless is Head of Business Engagement at Pulsora, managing all aspects of business engagement for prospective and existing clients, partnerships, and…

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Accelerating the Pace of Progress for Innovative Biologic Products
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Accelerating the Pace of Progress for Innovative Biologic Products

November 22, 2023

— Peter MarksDirector – Center for Biologics Evaluation and Research (CBER)FDA Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

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Fireside Chat: Innovating While Navigating a Complex Global Regulatory Landscape
TECHNOLOGY, VIDEO

Fireside Chat: Innovating While Navigating a Complex Global Regulatory Landscape

June 26, 2023

What do business leaders need to know about the ever-changing landscape of global regulation? The critical role of trust in today’s competitive business environment and changing stakeholder expectations for organizational leaders Updates on the latest developments in AI and understanding the opportunities and considerations for large organizations How can leaders balance potential risks and identify opportunities that come with new regulations Approaches for navigating compliance requirements while continuing to rapidly innovate and leverage the latest advancements in AI — Cari Benn Assistant Chief Privacy Officer Microsoft Cari Benn is Microsoft’s Assistant Chief Privacy Officer and is a leader in global…

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Quality and Compliance from the Regulators’ Perspective
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Quality and Compliance from the Regulators’ Perspective

May 25, 2023

What are regulators looking for when they engage with QA/QC executives and other senior leaders? How can industry facilitate these interactions? Thinking about your processes and facilities from the point of view of the inspector: What are you taking for granted based on familiarity or habit or tradition that would not apply to a fresh pair of eyes? Highlighting best practices to make ongoing documentation a powerful quality and compliance tool for the future Using compliance as a starting point: What does exceeding expectations look like, and how should pharmaceutical manufacturers stay ahead of that moving target in perpetuity? —…

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Practical Considerations for Establishing a Scope 3 Data Collection Strategy
Sustainability, SUSTAINABILITY, VIDEO

Practical Considerations for Establishing a Scope 3 Data Collection Strategy

February 8, 2023

The quest for more accurate Scope 3 GHG Emissions data is more important than ever with the changing regulatory and climate-action landscapes. However, Scope 3 data collection continues to be a challenge despite making up the bulk of most companies’ GHG inventory. Join this workshop to discuss: Best practices on how to take a differentiated approach to Scope 3 data collection and move up the Scope 3 maturity curve The importance of technology in facilitating accurate Scope 3 data collection Lessons learned from real-life Scope 3 programs — Amanda Petzinger Associate VP of ESG/Sustainability Digital Solutions Benchmark ESG Amanda Petzinger,…

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The New Net Zero : Carbon Markets Today and Tomorrow Under Article 6
Sustainability, SUSTAINABILITY, VIDEO

The New Net Zero : Carbon Markets Today and Tomorrow Under Article 6

March 21, 2023

With the historic agreement of Article 6 at COP26 last year and Net Zero commitments now covering over 80% of global emissions, governments will soon join the private sector in buying and selling carbon credits for Net Zero aims. But what does this mean for corporate voluntary commitments going forward? Are these two different markets and ledgers, or are they intertwined? What does this mean for corporate claims and ownership of the carbon credits and what should buyers planning long term purchasing of carbon credits look out for? The role of carbon markets in Net Zero and the size of…

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Unlocking the Promise of Gene Therapy
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Unlocking the Promise of Gene Therapy

November 28, 2022

Review the current state of gene therapy Discuss overcoming barriers to product development Make the case for global regulatory convergence Describe FDA actions facilitating gene therapy development — Peter Marks Director – Center for Biologics Evaluation and Research (CBER) FDA Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy…

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The New Era of Food Safety Needs a Great Team with Strong Leadership
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

The New Era of Food Safety Needs a Great Team with Strong Leadership

September 30, 2022

Demonstrating that even before the global pandemic, people have always been the catalysts of change and the difference-makers in every aspect of our business, and especially when it comes to Food Safety, Quality, and Compliance How do you identify, support, and develop the future leaders of your organization to carry on the FSQ values your company is built upon? Mobilizing the unique culture of our team to embracing transformation and fresh perspectives while holding onto the best of what has always driven positive outcomes in turbulent times Creating a framework that encourages all employees to unlock their potential personally and…

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Advancing Pharmaceutical Manufacturing Quality
LIFE SCIENCES, LIFE SCIENCES, VIDEO

Advancing Pharmaceutical Manufacturing Quality

April 8, 2022

 Using innovative thinking to realize a future more “immune” to supply chain disruptions Incentivizing improvements to the pharmaceutical manufacturing infrastructure that enhance the reliability of manufacturing and supply Delivering on the promise of advanced manufacturing to provide reliable, available, high-quality drugs for patients — Michael Kopcha Director, Office of Pharmaceutical Quality, CDER FDA Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise…

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