Agenda – 8th Clinical Trials Inspection Readiness Summit

  • Conference Day One
  • Conference Day Two

Conference Day One

 Monday, August 14

9:00AM – 9:00AM

CHAIRPERSON’S OPENING REMARKS
Katherine Taylor, Director, GCP Inspection Management, MERCK

9:15AM – 10:00AM

RECOGNIZE TOOLS TO FOSTER A CULTURE OF COLLABORATION AND INHERENT INSPECTION READINESS
Lydia Milne, Director, Quality Systems Inspection Program, ASTELLAS

10:00AM – 11:00AM

LESSONS LEARNED: LEVERAGING RESOURCES FOR SMALL TO MID-SIZE SPONSORS
Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY

11:00AM – 11:30AM

NETWORKING BREAK

11:30AM – 12:15PM

INTERNAL STAKEHOLDER COLLABORATIONS: CREATE INTER-DEPARTMENTAL EFFICIENCIES TO OPTIMIZE INSPECTION PREPARATION
Katherine Taylor, VP, Clinical Quality and Compliance, ASTRAZENECA

12:15PM – 1:00PM

MOCK INSPECTIONS: A CRITICAL TOOL TO ENSURE INSPECTION READINESS
Kristen Bennett, Associate Director, Client Delivery, THE AVOCA GROUP
Grace Crawford, VP, Clinical Quality and Compliance, ASTRAZENECA

1:00PM – 2:00PM

LUNCHEON

2:00PM – 2:45PM

BUILD EFFECTIVE TRAINING PROGRAMS FOR THE BIOPHARMA INDUSTRY
Sharon Brower, Director Training and Process and Continuous Improvements, BRISTOL-MYERS SQUIBB

2:45PM – 3:30PM

LESSONS LEARNED: BREAKING DOWN SILOS WITH CLINICAL OPS, TMF OPS, AND CLINICAL QUALITY — CREATING AN INSPECTION READINESS OVERSIGHT MODEL
Ann McCabe, Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO
Laura Naranjo, Manager, TMF Operations, Clinical Development Operations, DAIICHI SANKYO

3:30PM – 4:00PM

NETWORKING BREAK

4:00PM – 4:45PM

SUCCESSFUL PARTNERSHIPS AND COLLABORATION WITH CROS, SPONSORS, SITES, AND VENDORS
Julia Moore, Associate Director, SANGAMO THERAPEUTICS

4:45PM – 5:30PM

PANEL DISCUSSION: GLOBAL INSPECTION READINESS: HOW IT TRANSLATES INTO REAL-LIFE INSPECTION SUCCESS OR FAILURE
Nancy Bitters, Senior GCP/GVP Inspection Management Lead, EMD SERONO
Ann Taylor, Senior Quality Manager, Compliance, PFIZER

5:30PM – 5:30PM

DAY ONE CONCLUDES


Conference Day Two

 Monday, August 15

8:00AM – 8:45AM

CONTINENTAL BREAKFAST

8:45AM – 9:00AM

CHAIRPERSON’S OPENING REMARKS
Katherine Taylor, Director, GCP Inspection Management, MERCK

9:00AM – 9:45AM

CAPTURE INSPECTION READINESS THROUGH VENDOR OVERSIGHT STRATEGIES
Vinita Leslie, Head of Clinical Quality, Oncology, TAKEDA

9:45AM – 10:30AM

PANEL DISCUSSION: INSPECTION READINESS THROUGHOUT THE LIFE CYCLE: HOW TO STAY INSPECTION-READY
Michael Wieczerzak, Associate Director, Clinical Quality Management, EMD SERONO
Laura Naranjo, Manager, TMF Operations, Clinical Development Operations, DAIICHI SANKYO

If you are interested in joining this panel, contact Brianna Conetta at bconetta@questex.com or 212-400-6234.

10:30AM – 11:00AM

NETWORKING BREAK

11:00AM – 11:45AM

NAVIGATE THE SPONSOR AND SITE RELATIONSHIP THROUGHOUT AN INSPECTION
Alyssa Gateman, Director, QA, YALE SCHOOL OF MEDICINE
Linda Coleman, Director, Human Research Protection Program, YALE SCHOOL OF MEDICINE

11:45AM – 12:30PM

DISCUSS BEST PRACTICES FOR PREPARING, HOSTING, AND RESPONDING TO REGULATORY INSPECTIONS IN ACADEMIA
Johanna Stamates, Executive Director, Research Compliance and Quality Assurance,, UNIVERSITY OF MIAMI MEDICAL CENTER

12:30PM – 1:15PM

AUDIT TRIAL REVIEW AND GDPR: WHAT TO CONSIDER
Jamie Bridges, Director, GDMS, Operational Excellence, MERCK

1:15PM – 2:15PM

LUNCHEON

2:15PM – 3:15PM

PANEL DISCUSSION: MEETING THE CHALLENGES: WHAT CAN WE LEARN FROM OTHER COUNTRIES?
If you are interested in joining this panel, contact Brianna Conetta at bconetta@questex.com or 212-400-6234.

4:00PM – 4:00PM

CONFERENCE CONCLUDES