Agenda – 7th Clinical Trials Inspection Readiness Summit

  • Day One
  • Day Two

Day One

 

9:00AM – 9:15AM

Co-Chairperson’s Opening Remarks
Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
Katherine Taylor, Director, GCP Inspection Lead/ GCP Inspection Management, MERCK

9:15AM – 10:00AM

CASE STUDY: Data Management and Focused Inspection Challenges
Jamie Bridges, Director, GDMS, Operational Excellence, MERCK

10:00AM – 10:45AM

Update on the Impact of ICH E6 R2, Partnerships and Collaborations with CROs
Ann McCabe, Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

CASE STUDY: Challenges of Quality Oversight with Business Stakeholders: Vendor Management
Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
Gerry Grove, Director, Clinical Operations, Respiratory, Inflammatory and Autoimmunity, MEDIMMUNE

12:00PM – 1:00PM

PANEL: Meeting the Challenges: FDA Inspections in the US
Panelists:
Nancy Bitters, GCP/GVP Inspection Management Lead, EMD SERONO
Vaishali Shukla, Head of Clinical QA and Product Quality Management, UNIQURE
Ann Taylor, Inspection Readiness Lead, Director, PFIZER
Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
Katherine Taylor, Director, GCP Inspection Lead/ GCP Inspection Management, MERCK

1:00PM – 2:00PM

Luncheon

2:00PM – 2:45PM

Comparing How Agencies Conduct Inspections – What are the Implications of ICH E6 (R2) Based on Recent Inspection Experiences?
Steven B. Whittaker, Senior Consultant , Executive Director, The Avoca Quality Consortium™

2:45PM – 3:30PM

Ensure Smooth Inspections by Establishing a Good Relationship Between Sponsor and Vendor
Vaishali Shukla, Head of Clinical QA and Product Quality Management, UNIQURE

3:30PM – 4:15PM

Top-10 Pharma Case Study: Training Documentation - A Journey to Perpetual Inspection Readiness
Rick Ward, VP, Commercial Operations, TRIFECTA CLINICAL
Sarah O'Hora, Director, Vault Clinical, Veeva

4:15PM – 4:45PM

Networking Break

4:45PM – 5:30PM

Lessons learned and Best Practices of Managing Your TMF for an Inspection
Laura Naranjo, Manager, TMF Operations, DAIICHI SANKYO

5:30PM – 6:15PM

Mock Inspections: Understand How to Document, Handle the Scheduling of, and Decide When to Hold Them
Kathy Goldstein, Sr. Director, Quality Management Lead, REGENERON PHARMACEUTICALS
Sheila Gwizdak, Senior Consultant , HALLORAN CONSULTING GROUP
Lydia Milne, Director Quality Systems Inspection Program, Astellas

6:15PM – 7:15PM

Cocktail Reception


Day Two

 

8:00AM – 9:00AM

Continental Breakfast

9:00AM – 9:15AM

Co-Chairpersons’ Recap of Day One
Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
Katherine Taylor, Director, GCP Inspection Lead/ GCP Inspection Management, MERCK

9:15AM – 10:00AM

Inspection Management: Focus on How to Bring Partnerships and Collaboration With CROs
Katherine Taylor, Director, GCP Inspection Lead/ GCP Inspection Management, MERCK

10:00AM – 10:45AM

Navigating GCP in Medical Device Trials: ISO14155 VS. ICH E6 R2
Carrie Lauer, Senior Manager Clinical Operations, GE HEALTHCARE

10:45AM – 11:15AM

Networking Break

11:15AM – 12:15PM

Regulatory Inspections in Academia: Preparation — Hosting — Responding
Johanna Stamates, Executive Director, Research Compliance and Quality Assurance, University of Miami

12:15PM – 1:15PM

Luncheon

1:15PM – 2:15PM

Prepare for an Inspection — Current Trends and Recent Encounters
Elias Dorfman, Director, Headquarters Clinical Quality Management, MERCK