Agenda – 8th Clinical Trials Inspection Readiness Summit

  • Conference Day One
  • Conference Day Two

Conference Day One

 Wednesday, August 14

9:00AM – 9:15AM

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

9:15AM – 10:00AM

HOW TO PREPARE FOR AN FDA CLINICAL INVESTIGATOR INSPECTION
Stephanie Mangigian, Commander, United Public Health Service, Certified Bioresearch Monitoring Specialist, FOOD AND DRUG ADMINISTRATION

10:00AM – 11:00AM

THE TMF HEALTH ZONE: TELLING THE STORY
Marion Mays, VP Client Solutions and Quality Assurance, PHLEXGLOBAL

11:00AM – 11:30AM

NETWORKING BREAK

11:30AM – 12:15PM

INTERNAL STAKEHOLDER COLLABORATIONS: CREATE INTER-DEPARTMENTAL EFFICIENCIES TO OPTIMIZE INSPECTION PREPARATION
Christina DeLuca, GCP Inspection Lead, Associate Director, MERCK
Katherine Taylor, Director, GCP Inspection Management, MERCK

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

PREPARING AN INSPECTION READY WAR ROOM
Darshan Kulkarni, FDA Regulatory and Compliance Attorney, THE KULKARNI LAW FIRM

4:45PM – 5:30PM

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

5:30PM – 5:30PM

DAY ONE CONCLUDES


Conference Day Two

 Thursday, 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: GLOBAL INSPECTION READINESS: HOW IT TRANSLATES INTO REAL-LIFE INSPECTION SUCCESS OR FAILURE
Stacey Basham, Director, Clinical Quality Assurance, ABBVIE
Nancy Bitters, Senior GCP/GVP Inspection Management Lead, EMD SERONO
Tian Luo, Clinical Inspection Readiness Leader, SANOFI

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

PANEL DISCUSSION: INSPECTION READINESS THROUGHOUT THE LIFE CYCLE: HOW TO STAY INSPECTION-READY
Laura Naranjo, Manager, TMF Operations, Clinical Development Operations, DAIICHI SANKYO
Craig Reist, Ph.D., Assistant Director, Megatrials, DUKE CLINICAL RESEARCH INSTITUTE
Eric Rubinson, Director, R&D Solutions, INTRA-CELLULAR THERAPIES, INC
Michael Wieczerzak, Associate Director, Clinical Quality Management, EMD SERONO

12:30PM – 1:15PM

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

1:15PM – 2:15PM

LUNCHEON

2:15PM – 3:15PM

DISCUSS BEST PRACTICES FOR PREPARING, HOSTING, AND RESPONDING TO REGULATORY INSPECTIONS IN ACADEMIA
Nelson A. Vega, Manager, Quality Assurance, University of Miami

4:00PM – 4:00PM

CONFERENCE CONCLUDES