Agenda – Central Monitoring Summit

  • Day One
  • Day Two

Day One

 THURSDAY, MARCH 22

9:00AM – 9:15AM

CO-CHAIRS’ OPENING REMARKS
Lisa Berdan, Director, Global Megatrials, DUKE CLINICAL RESEARCH INSTITUTE
Kimberly Nessel, Director, Clinical Scientist CVM, JANSSEN R&D

9:15AM – 10:15AM

ROUNDTABLE DISCUSSION
MANAGE STRATEGIES FOR ADOPTION AND IMPLEMENTATION OF ICH E6 (R2) AND EXPLORE HOW IT AFFECTS CENTRAL MONITORING

Moderator:
Lisa Berdan, Director Global Megatrials, DUKE CLINICAL RESEARCH INSTITUTE

10:15AM – 11:00AM

STRATEGIZE FOR THE SUCCESSFUL ADOPTION AND IMPLEMENTATION OF CENTRAL MONITORING
Oksana Gecha, Head of Central Monitoring Global Data Strategies and Solutions (GDSS), BRISTOL-MYERS SQUIBB
David Bocobo, Senior Central Monitor — Risk-Based Monitoring, BRISTOL-MYERS SQUIBB

11:00AM – 11:30AM

NETWORKING BREAK

11:30AM – 12:15PM

ROLE OF MEDICAL REVIEW AS A COMPONENT OF CENTRAL MONITORING — JANSSEN CLINICAL TEAM APPROACH
Kimberly Nessel, Director, Clinical Scientist CVM, JANSSEN R&D

12:15PM – 1:30PM

LUNCHEON

2:15PM – 3:00PM

DISCOVER HOW TO IMPLEMENT RBM WITH ENDPOINT COLLECTION AS A FOCAL POINT OF CENTRALIZED MONITORING
Morten Thorup Pedersen, Risk-Based Monitoring Specialist, NOVO NORDISK A/S

3:00PM – 3:30PM

NETWORKING BREAK

3:30PM – 4:15PM

DRILL DOWN ON DATA SETS TO IDENTIFYING INCONSISTENCIES BEFORE THEY IMPACT STUDY RESULTS
Sina Djali, Head of Risk Management — Central Monitoring Integrated Data Analytics and Reporting Global Clinical Development Operations, JANSSEN R&D

4:15PM – 5:00PM

DISCOVER DRUG SAFETY ASSESSMENT IN CENTRAL MONITORING
Dr. Jaylaxmi Nalawade, Senior Manager — Drug Safety and Risk Management, LUPIN LIMITED

5:00PM –

END OF DAY ONE


Day Two

 FRIDAY, MARCH 23

9:00AM – 9:15AM

CO-CHAIRS’ RECAP OF DAY ONE
Lisa Berdan, Director Global Megatrials, Duke Clinical Research Institute
Kimberly Nessel, Director, Clinical Scientist CVM, JANSSEN R&D

9:15AM – 10:00AM

RESPOND TO THE SHIFTING ROLE OF A CRA, ACTIVELY SUPPORTING SITE STAFF TO TAKE GREATER OWNERSHIP OF PROCESS COMPLIANCE AND ACCURATE DATA REPORTING
Elizabeth Robinson, RN, MSHS, Executive Director, Clinical Compliance and Operations, HORIZON PHARMA

10:00AM – 10:30AM

NETWORKING BREAK

10:30AM – 11:15AM

CASE STUDY: CENTRAL MONITORING: HOW OFTEN DO WE REALLY NEED TO GO ON-SITE?
Anne M. Smith, Consultant, Central Monitoring, ELI LILLY AND COMPANY

12:00PM – 1:15PM

LUNCHEON

1:15PM – 2:00PM

HEAR A SMALL COMPANY PERSPECTIVE ON THE USE OF CENTRALIZED MONITORING
Jennessa Martin, Regulatory A airs Coordinator, FIBROCELL SCIENCE

2:00PM – 2:30PM

NETWORKING BREAK

2:30PM – 3:30PM

WORKING TOGETHER — SITE, SPONSOR AND CRO PERSPECTIVE
Oksana Gecha, Head of Central Monitoring Global Data Strategies and Solutions (GDSS), BRISTOL-MYERS SQUIBB