Agenda – 6th Clinical Trials Inspection Readiness Summit

  • Day One
  • Day Two

Day One

 Day One – Monday, August 7

9:00AM – 9:15AM

Chairperson’s Opening Remarks
Ivan Walrath, Head of Audit and Inspection Quality, PFIZER

9:15AM – 10:00AM

Clinical Trial Quality Management: A Journey to Inspection Readiness
Jonathan Rowe, Head of Quality Performance and Risk Management, Pfizer

10:00AM – 10:45AM

Determine How Quality Management Systems Can Improve Inspection Readiness and Promote Quality
Stephanie deRijke, Director, Clinical Trials Audit and Compliance, EMORY UNIVERSITY
Susan Seroskie, RN, BSN, Senior Manager, Global Quality Management, Otsuka Pharmaceutical Companies

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Assessment of ICH E6 R2 - Implications for Corporate Quality Management and Inspection Readiness
Steven Whittaker, Executive Director, AVOCA QUALITY CONSORTIUM; Senior Consultant, THE AVOCA GROUP

12:00PM – 12:45PM

Maintain an Inspection-Ready TMF
Dawn Niccum, Director, Quality Assurance, INSEPTION GROUP

12:45PM – 2:00PM

Luncheon

2:00PM – 3:45PM

Mock Inspection Activity: FDA
Tipsuda Kongtong, Manager, Clinical Quality Assurance, EISAI
Nancy Bitters, Inspection Management Lead, Biopharma | Global Research and Development Quality, EMD SERONO
Stacey Basham, Assistant Director, R&D GCP Quality Assurance, ABBVIE
Ivan Walrath, Head of Audit and Inspection Quality, PFIZER

3:45PM – 4:15PM

Networking Break

4:15PM – 5:00PM

Use Regulatory Surveillance to Proactively Identify Areas of Increased Regulatory Risk
Andreas Kateifides, Compliance Oversight Systems, VERTEX PHARMACEUTICALS

5:00PM – 5:00PM

Conference Day One Ends


Day Two

 Day Two – Tuesday, August 8

8:15AM – 9:00AM

Continental Breakfast

9:00AM – 9:15AM

Chairperson’s Recap of Day One
Ivan Walrath, Head of Audit and Inspection Quality, PFIZER

9:15AM – 11:00AM

PANEL: Navigating a China FDA Inspection – Discover the Differences From Experts Who Have Been There
Moderator:
Nancy Bitters, Inspection Management Lead, Biopharma | Global Research and Development Quality, EMD SERONO

Panelist:
Stacey Basham, Assistant Director, R&D GCP Quality Assurance, ABBVIE
Ann Taylor, Clinical Quality Manager, Associate Director, PFIZER
Rachael Easton, Senior Director, Translational Medicine and Clinical Pharmacology, SANOFI

11:00AM – 11:30AM

Networking Break

11:30AM – 12:15PM

eTMF Study Migrations – Planning With Inspection Readiness in Mind
Lou Pasquale, Customer Success, Content Management Solutions, WINGSPAN, a QUINTILESIMS COMPANY

12:15PM – 1:00PM

GCP Hot Topics – An Interactive Session
Linda M. Coleman, Director, Human Research Protection Program, YALE UNIVERSITY
Alyssa K. Gateman, Associate Director, Yale Center for Clinical Investigations, Director Office of Quality Assurance and Training, YALE UNIVERSITY

1:00PM – 2:15PM

Luncheon

2:15PM – 3:00PM

Challenges and Opportunities Presented by the Adoption of Electronic Systems Storing Electronic Records
Betsy Fallen, Special Topics Consultant, SAFE-BIOPHARMA ASSOCIATION

3:00PM – 3:45PM

Manage Oversight of Outsourced Trials to Remain Prepared and Ready for Inspections and Ensure Quality
Angela Berns, Director and Head of Vendor Management, UCB SA

3:45PM – 4:00PM

Chairperson’s Closing Remarks
Ivan Walrath, Head of Audit and Inspection Quality, PFIZER

4:00PM – 4:00PM

Conference Concludes