Tag

Compliance

Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy

May 17, 2024

Anil Sawant is Senior Vice President, Global Quality Compliance at Merck. He is a healthcare Executive with over 35 years of operations experience in Quality Operations, Ethics & Compliance, Research Integrity and Auditing functions. A strategic thinker experienced in development and deployment of management controls, governance processes, and quality and compliance systems in diverse business environments and cultures. Anil leads groups managing branded and generic products, small molecules, vaccines, bio-pharmaceutical, medical devices and consumer products. He was part of the teams that commercialized the first antibody-drug conjugate product and first photoactive drug. Expertise in interpretation of GMPs, GLPs, and GCPs. Good understanding of SOX, Anti-Kickback, Anti-Trust, Privacy and FCPA. Skilled crisis manager and pragmatic thinker with excellent understanding of regulatory requirements, global pharmaceutical supply chain and R&D operations. Extensive experience in resolving compliance matters with US FDA and international regulatory agencies. Subject matter expert in pharmaceutical microbiology and aseptic processing.

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The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services

May 30, 2024

JR Humbert is currently the VP, Quality at INCOG BioPharma Services, and created and implemented the quality system at INCOG, which in three years went from company creation through successful FDA inspection in 3 years.

JR has over 20 years of pharmaceutical and biotechnology industry experience in validation, quality, technology transfer, process engineering, and program management. Some of JR’s previous companies include Piramal Pharma Solutions, Roche/Genentech, Hospira, and Cook Pharmica.

JR has participated in multiple global health authority inspections and developed inspection responses. JR has an MBA from Indiana University, and a BA in Chemistry and Biochemistry from the University of Colorado-Boulder.

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Peter Shearstone of Thermo Fisher Scientific — Changing the Compliance Paradigm in Large, Global Companies
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

Peter Shearstone of Thermo Fisher Scientific — Changing the Compliance Paradigm in Large, Global Companies

July 22, 2024

As part of the 2024 edition of the Pharma Manufacturing World Summit we interviewed Peter Shearstone, Thermo Fisher Scientific’s VP Global Quality & Regulatory Affairs, about a themed lunch discussion he hosted that revolved around Compliance in the pharmaceutical space, especially as it related to companies with a worldwide footprint. How does Compliance shape the way businesses function? How is that changing over time? How did the pandemic change the way the pharmaceutical industry thinks about itself and problem-solves? What can large organizations learn from the capabilities and outlook of smaller and more nimble companies? What are the things global companies will always do well, but can still do better? What should every leader working in this space be thinking about and learning about and doing more of to improve themselves, their teams, and the industry as a whole? For all this and more, give this episode a listen!

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Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects

May 22, 2024

At the 2024 edition of the Pharma Manufacturing World Summit we sat down with Teresa Gorecki of Compliance Architects to speak with enthusiasm and optimism about the future of medicine, the most recent developments and what they mean for patients, but especially the most recent ideas and information pharmaceutical manufacturers and other senior leaders in the Life Sciences need to know as the industry moves forward together into a very exciting time. What are some of the top-of-mind challenges and opportunities pharma manufacturers are dealing with right now, and how are the early adaptors already addressing those issues? How are regulators working with industry to improve end results for patients? How is commercialization of ATMPs progressing, and what can we all learn from the first examples coming online now? For all this and more, give this episode a listen!

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

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, VIDEO, SUSTAINABILITY

Conquering Complexity: Scaling ESG Reporting in the New Regulatory Landscape

April 5, 2024

Nicole Peerless is Head of Business Engagement at Pulsora, managing all aspects of business engagement for prospective and existing clients, partnerships, and marketing. Nicole joined Pulsora’s leadership team with over fifteen years experience in the investment industry, both in private equity and leading the Investors Industry at the World Economic Forum. While at WEF, she spearheaded the ESG in private markets activities and led a global team overseeing the Forum’s community of asset owners and fund managers.

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

Accelerating the Pace of Progress for Innovative Biologic Products

November 22, 2023

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

Cari Benn is Microsoft’s Assistant Chief Privacy Officer and is a leader in global privacy and data protection strategy. She is passionate about building a strong privacy culture that drives responsible innovation and respectful data use. Cari focuses on Microsoft’s strategy for advancing privacy in artificial intelligence, enterprise cloud and consumer services, and emerging technologies that underpin the world’s digital transformation.

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

Quality and Compliance from the Regulators’ Perspective

May 25, 2023

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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The Post-Pandemic FDA, Cell & Gene Therapy Updates, and Other Industry News — A Conversation with Teresa Gorecki of Compliance Architects LLC
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

The Post-Pandemic FDA, Cell & Gene Therapy Updates, and Other Industry News — A Conversation with Teresa Gorecki of Compliance Architects LLC

June 6, 2023

At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Teresa Gorecki of Compliance Architects LLC about what pharmaceutical manufacturers should expect from regulators as the pandemic winds down, where we are and where we’re going as the pipeline of Cell & Gene Therapies marches towards commercialization, and a wide range of other industry issues, challenges, and opportunities. This is a great conversation that speaks to a lot of key points of interest for pharmaceutical manufacturers of all shapes and sizes. Give it a listen!

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

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, VIDEO, SUSTAINABILITY

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, VIDEO, LIFE SCIENCES

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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