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FDA

Accelerating the Pace of Progress for Innovative Biologic Products
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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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Quality and Compliance from the Regulators’ Perspective
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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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Unlocking the Promise of Gene Therapy
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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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FDA Regulatory Update: Moving from Outbreak to Prevention
FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

FDA Regulatory Update: Moving from Outbreak to Prevention

October 4, 2022

Whole Genome Sequencing has revolutionized CDC and FDA disease attribution capabilities.  With better detection comes more outbreaks. The FDA is developing prevention strategies for food categories with recurrent attribution to disease.  These prevention strategies are an opportunity for all stakeholders to focus on prevention in that category. The FDA is ramping up to conduct Root Cause Analysis following foodborne illness outbreaks.  Our reports will communicate what we learn to help firms prevent a recurrence. — Mark Moorman Director, Office of Food Safety FDA Mark Moorman is the Director of the Office of Food Safety at the Food and Drug Administration…

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Advancing Pharmaceutical Manufacturing Quality
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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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The Transformational Potential of the Advanced Manufacturing of Biologics
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The Transformational Potential of the Advanced Manufacturing of Biologics

November 30, 2021

Describe the potential for advanced manufacturing Review case studies illustrating the potential of advantages advanced manufacturing Provide resources for product developers Peter Marks Director – Center for Biologics Evaluation and Research (CBER) 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…

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FOOD SAFETY & QUALITY, FOOD SAFETY & QUALITY, VIDEO

Regulator Keynote: New Era of Smarter Food Safety – A Progress Report

October 13, 2021

Overview of initiative First year accomplishments A look ahead — Sharon Lindan Mayl, J.D. Senior Advisor for Policy, Office of Food Policy and Response FDA SHARON LINDAN MAYL, J.D. has been with FDA for more than 25 years and currently serves as Senior Advisor for Policy in the Office of Food Policy and Response. In this position, she oversees and manages significant policy initiatives in the foods area.  Among other issues, Ms. Mayl is the implementation lead for FDA’s New Era of Smarter Food Safety initiative, which seeks to develop a new approach to food safety that leverages technology and other…

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Regulator Keynote: Updates, Progress Reports, and Looking Forward to the Future
FOOD SAFETY & QUALITY, VIDEO

Regulator Keynote: Updates, Progress Reports, and Looking Forward to the Future

July 1, 2019

Offering updates on the FDA’s policies and priorities. Sharon Lindan Mayl, J.D. Senior Advisor for Policy, Office of Food Policy and Response FDA Sharon serves as the Senior Advisor for Policy, Office of Food Policy and Response. In this position, she oversees and manages significant policy initiatives related to food safety. She currently focuses on implementation of the FDA Food Safety Modernization Act (FSMA). Ms. Mayl co-leads the team responsible for the FSMA import rules and guidance documents, including those related to the Foreign Supplier Verification Program, Voluntary Qualified Import Program, and Accredited Third-Party Certification Program as well as the…

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Regulator Keynote: Progress, Updates, and What Comes Next
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Regulator Keynote: Progress, Updates, and What Comes Next

June 20, 2018

FSMA continues to change the way the food industry works. How are things progressing, and where do we still need to go? How are regulators working with industry to ensure an orderly and effective rollout of new initiatives and standards? Discussing metrics and timelines for how our ongoing projects and programs impact public safety Updating information on new policies, priorities, and guidelines Reviewing the most frequently asked questions by quality and compliance professionals — Joann Givens Food and Feed Program Director (HAF-W) Food and Drug Administration Ms. Joann M. Givens serves as Office of Regulatory Affairs’ Human and Animal Food…

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FSMA Update: Where Are We Now, and Where Do We Need to Be?
FOOD SAFETY & QUALITY, VIDEO

FSMA Update: Where Are We Now, and Where Do We Need to Be?

July 14, 2017

With six of the seven deadlines now passed on the final rules, where are companies still falling short? How are regulators working with industry to ensure an orderly and effective rollout of new initiatives and standards? Discussing early metrics for how FSMA is impacting public safety Updating information on new policies, priorities, and guidelines Reviewing the most frequently asked questions by quality and compliance professionals — Joann Givens Human and Animal Food Program Director, Office of Regulatory Affairs & Co-chair – FSMA Operations Team Steering Committee at Food and Drug Administration Ms. Joann M. Givens serves as Office of Regulatory…

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