Agenda – 7th Clinical Trials Inspection Readiness Summit

  • Day One
  • Day Two

Day One

 

9:00AM – 9:15AM

CO-CHAIRPERSONS’ 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 – 10:30AM

UPDATE ON THE IMPACT OF ICH E6 R2, PARTNERSHIPS AND COLLABORATION WITH CROS
Ann McCabe, Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO

10:30AM – 11:00AM

NETWORKING BREAK

11:00AM – 11:45AM

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

11:45AM – 12:45PM

MEETING THE CHALLENGES: INSPECTIONS IN USA
Moderator:
Tipsuda Kongtong, Manager, Clinical Quality Assurance, EISAI
Nancy Bitters, GCP/GVP Inspection Management Lead, EMD SERONO
Vaishali Shukla, Head of Clinical QA and Product Quality Management, UNIQURE

12:45PM – 1:45PM

LUNCHEON

1:45PM – 2:30PM

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™

2:30PM – 3:15PM

ENSURE SMOOTH INSPECTIONS BY ESTABLISHING A GOOD RELATIONSHIP BETWEEN SPONSOR AND VENDOR
Vaishali Shukla, Head of Clinical QA and Product Quality Management, UNIQURE

3:15PM – 3:45PM

NETWORKING BREAK

3:45PM – 4:30PM

LESSONS LEARNED AND BEST PRACTICES OF MANAGING YOUR TMF FOR AN INSPECTION
Laura Naranjo, Manager, TMF Operations, DAIICHI SANKYO

4:30PM – 5:30PM

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


Day Two

 

8:00AM – 9:15AM

CONTINENTAL BREAKFAST

9:15AM – 9:30AM

CO-CHAIRPERSONS’ RECAP OF DAY ONE
Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
Katherine Taylor, Director, GCP Inspection Lead/ GCP Inspection Management, MERCK

9:30AM – 10:15AM

INSPECTION MANAGEMENT: FOCUS ON HOW TO BRING PARTNERSHIPS AND COLLABORATION WITH CROS
Katherine Taylor, Director, GCP Inspection Lead/ GCP Inspection Management, MERCK

10:15AM – 11:00AM

NAVIGATING GCP IN MEDICAL DEVICE TRIALS: ISO14155 VS. ICH E6 R2
Carrie Lauer, Senior Manager Clinical Operations, GE HEALTHCARE

11:00AM – 11:30AM

NETWORKING BREAK

11:30AM – 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 – 2:30PM

PREPARE FOR AN INSPECTION — FOLLOW TRENDS AND CURRENT ENCOUNTERS
Elias Dorfman, Director, Headquarters Clinical Quality Management, MERCK