Part 1 Agenda
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| 1:30 p.m. - 1:35 p.m. |
Welcoming Remarks
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
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| 1:35 p.m. - 2:00 p.m.
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Keynote Address: Date Integrity Before, During & After COVID-19
Sarah Barkow, Lead GxP External Engagement, Bristol Myers Squibb; former Lead Consumer Safety Officer and Acting Director, Manufacturing Quality Guidance and Policy Staff, CDER, FDA
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2:00 p.m. - 2:45 p.m.
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Five Most Significant Impacts of COVID-19 on Data Integrity
What are the most significant impacts of COVID-19 on how pharmaceutical and medical device manufacturers implement their overall operations, secure their supply chain and conduct clinical trials? What innovative business practices will remain in the “new normal” after COVID-19? What is the impact on data integrity for regulatory, quality, compliance and data integrity specialists going forward?
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
Panelists:
John Avellanet, Managing Director & Principal Consultant, Cerulean Associates
Dave Chesney, Principal and General Manager, DL Chesney Consulting, LLC
Beverly Lorell, Senior Medical and Policy Advisor, FDA and Life Sciences Practice, King & Spalding |
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| 2:45 p.m. - 3:00 p.m.
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Break |
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| 3:00 p.m. - 3:45 p.m.
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FDA’s Regulatory Stance
What new guidance issued during COVID-19 has most affected data integrity and impacted pharmaceutical, medical device regulatory and clinical trials professionals? Are these sets of guidance likely to still be in force in the post-COVID-19 era? What are the most problematic compliance issues as we look ahead to 2021?
Moderator:
John Avellanet, Managing Director & Principal Consultant, Cerulean Associates
Panelist:
Beverly Lorell, Senior Medical and Policy Advisor, FDA and Life Sciences Practice
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health |
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3:45 p.m. - 4:30 p.m.
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Virtual Inspections & Audits
How has COVID-19 changed the way the pharmaceutical and medical device industry approach inspections and audits? Who’s doing virtual inspections and audits? What are the major challenges and pitfalls when considering virtual inspections and audits? What best practices can companies deploy to ensure virtual inspections and audits are acceptable and compliant?
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
Panelist:
Dave Chesney, Principal and General Manager, DL Chesney Consulting, LLC
David Elder, Executive Vice President, Regulatory Compliance, Greenleaf Health |
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4:30 p.m. - 5:00 p.m.
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Unanswered Questions
Moderator:
Sue Schniepp, Distinguished Fellow, Regulatory Compliance Associates
Panelist:
John Avellanet, Managing Director & Principal Consultant, Cerulean Associates
Sarah Barkow, Lead GxP External Engagement, Bristol Myers Squibb
Dave Chesney, Principal and General Manager, DL Chesney Consulting, LLC
Beverly Lorell, Senior Medical and Policy Advisor, FDA and Life Sciences Practice
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health |
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| 5:00 p.m.
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Adjournment |
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