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Agenda

Enhance Process and System Interopability to Optimize Data Quality, Improve Trial Efficiency and Ensure Protection of Human Subjects

November 13-14, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Wednesday, November 13, 2019

7:00

Main Conference Registration and Continental Breakfast

8:00

Co-Chairs’ Welcome and Opening Remarks

Lisa G. Berdan, PA, MHS
Director, Global MegaTrials
Duke Clinical Research Institute

Stephanie Clark
Director, Risk-Management Central Monitoring
Janssen R&D

Latest Regulatory Changes and Ways to Use Data Quality to Boost Efficiency

8:15

Review the Latest Regulatory Documentand the Impact on RBM

Andy Lawton
Director
Risk-Based Approach Ltd

9:00

Next Generation Risk-Based Methodologies to Ensure ICH E6 (R2) Success

Steve Young
Chief Operations Officer
CluePoints

9:45

Networking and Refreshment Break

10:15

CASE STUDYApplying a Risk-Based Mindset in Operational Data

Julie Solbjerg Appel
Clinical Data Surveillance Specialist
Novo Nordisk A/S

Morten Thorup Pedersen
Risk-Based Monitoring Specialist
Novo Nordisk A/S

11:00

Leveraging Existing Data for Greater Insight into your Study

Michael Arlotto
President and Founder
Remarque Systems

11:45

Risk-Based Monitoring — A Joint Focus on Meaningful Risk Signal Detection and a Process for Action

Erin Reynolds
Manager Clinical Analytics, Data and Statistical Science Research & Development
AbbVie

12:30

Networking Luncheon

1:30

ARBM Compliance Challenges and Inspection/Audit Lessons Learned

Lewis Hower, BSc
Director, Risk Management, Central Monitoring
Janssen R&D

Sean Graham
Manager, Risk Management, Central Monitoring
Janssen R&D

2:15

Strengthen Risk-Based Strategies Using Predictive Analytics, A.I. and Machine Learning

Zabir Macci
Associate Director, Process Design & Analytics Centralized Monitoring
IQVIA

3:00

Networking and Refreshment Break

3:45

Beyond Risk Assessment –What Does Effective Risk Management Look Like and How Does This Affect Ongoing Monitoring Strategy?

Duncan Hall
CEO and Founder
Triumph Research Intelligence (TRI)

4:15

RBM Using Total Trial Management

Kristin Stallcup
Senior Director, Xcellerate Customer Success
Covance Inc

5:00

BYOT (Bring Your Own Topic) Think Tank — Optimize Your RBM Processes and System Interoperability

FACILITATOR:

Amy Neubauer
Director, Data Quality Oversight
Alkermes, Inc.

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Thursday, November 14, 2019

7:30

Continental Breakfast

8:00

Co-Chairs’ Review of Day One

Lisa G. Berdan, PA, MHS
Director, Global MegaTrials
Duke Clinical Research Institute

Stephanie Clark
Director, Risk-Management Central Monitoring
Janssen R&D

Identify Effective and Compliant Practices for Monitoring Data, Regulatory Audits and CRO Oversight

8:15

Stay on the Pulse of RBM and ICH-E6 (R2) Adoption in Clinical Trials

Abby Abraham
Vice President of Data Analytics and Risk-Based Monitoring
OmniComm Systems, Inc.

9:00

Monitoring Real-World Data

Lisa G. Berdan, PA, MHS
Director, Global MegaTrials
Duke Clinical Research Institute

9:45

Practical Usage of KRIs and QTLs in Clinical Trials

Artem Andrianov, Ph.D.
CEO
Cyntegrity

10:30

Networking and Refreshment Break

11:00

Is It Even Possible to Oversee CROs In the RBM Model?

Esther M. Huffman O’Keefe
Associate Director, Monitoring, Global Clinical Operations
Regeneron

Regulatory Compliance in RBM

11:45

Utilizing RBM to Oversee Critical Vendor Data

Laureen Dorschel
Clinical Study Risk Manager, Clinical Data Operations, Technology and Standards,
UCB Biosciences, Inc.

John (Jay) Daly
Clinical Study Risk Manager, Clinical Data Operations, Technology, and Standards
UCB Biosciences, Inc.

12:30

Networking Luncheon

1:30

PANELPost Implementation of RBM — Regulatory Inspections — What Have We Learned?

MODERATOR:

Steve Young
Chief Operations Officer
CluePoints

PANELISTS:

Lisa G. Berdan, PA, MHS
Director, Global MegaTrials
Duke Clinical Research Institute

Lewis Hower
Director, Risk Management, Central Monitoring
Janssen

Phi Tat
Central Monitor (Sr. Associate)
Pfizer

Gain Insight into Future Trends in RBM

2:15

PANELThe Latest and Greatest Brought to You by TransCelerate

MODERATOR:

Andy Lawton
Director
Risk-Based Approach Ltd

PANELISTS:

Esther M. Huffman O’Keefe
Associate Director, Monitoring, Global Clinical Operations
Regeneron

Phi Tat
Central Monitor (Sr. Associate)
Pfizer

Mary Arnould
Director/RBM Lead, Clinical Science Operations
Astellas

3:00

Emerging Trends in Source Data Review (SDR) vs. Source Data Verification (SDV)

Mary Arnould
Director/RBM Lead, Clinical Science Operations
Astellas

3:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Wednesday, November 13, 2019

7:00

Main Conference Registration and Continental Breakfast

8:00

Co-Chairs’ Welcome and Opening Remarks

Lisa G. Berdan, PA, MHS
Director, Global MegaTrials
Duke Clinical Research Institute

Stephanie Clark
Director, Risk-Management Central Monitoring
Janssen R&D

Latest Regulatory Changes and Ways to Use Data Quality to Boost Efficiency

8:15

Review the Latest Regulatory Documentand the Impact on RBM

Andy Lawton
Director
Risk-Based Approach Ltd

9:00

Next Generation Risk-Based Methodologies to Ensure ICH E6 (R2) Success

Steve Young
Chief Operations Officer
CluePoints

9:45

Networking and Refreshment Break

10:15

CASE STUDYApplying a Risk-Based Mindset in Operational Data

Julie Solbjerg Appel
Clinical Data Surveillance Specialist
Novo Nordisk A/S

Morten Thorup Pedersen
Risk-Based Monitoring Specialist
Novo Nordisk A/S

11:00

Leveraging Existing Data for Greater Insight into your Study

Michael Arlotto
President and Founder
Remarque Systems

11:45

Risk-Based Monitoring — A Joint Focus on Meaningful Risk Signal Detection and a Process for Action

Erin Reynolds
Manager Clinical Analytics, Data and Statistical Science Research & Development
AbbVie

12:30

Networking Luncheon

1:30

ARBM Compliance Challenges and Inspection/Audit Lessons Learned

Lewis Hower, BSc
Director, Risk Management, Central Monitoring
Janssen R&D

Sean Graham
Manager, Risk Management, Central Monitoring
Janssen R&D

2:15

Strengthen Risk-Based Strategies Using Predictive Analytics, A.I. and Machine Learning

Zabir Macci
Associate Director, Process Design & Analytics Centralized Monitoring
IQVIA

3:00

Networking and Refreshment Break

3:45

Beyond Risk Assessment –What Does Effective Risk Management Look Like and How Does This Affect Ongoing Monitoring Strategy?

Duncan Hall
CEO and Founder
Triumph Research Intelligence (TRI)

4:15

RBM Using Total Trial Management

Kristin Stallcup
Senior Director, Xcellerate Customer Success
Covance Inc

5:00

BYOT (Bring Your Own Topic) Think Tank — Optimize Your RBM Processes and System Interoperability

FACILITATOR:

Amy Neubauer
Director, Data Quality Oversight
Alkermes, Inc.

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Thursday, November 14, 2019

7:30

Continental Breakfast

8:00

Co-Chairs’ Review of Day One

Lisa G. Berdan, PA, MHS
Director, Global MegaTrials
Duke Clinical Research Institute

Stephanie Clark
Director, Risk-Management Central Monitoring
Janssen R&D

Identify Effective and Compliant Practices for Monitoring Data, Regulatory Audits and CRO Oversight

8:15

Stay on the Pulse of RBM and ICH-E6 (R2) Adoption in Clinical Trials

Abby Abraham
Vice President of Data Analytics and Risk-Based Monitoring
OmniComm Systems, Inc.

9:00

Monitoring Real-World Data

Lisa G. Berdan, PA, MHS
Director, Global MegaTrials
Duke Clinical Research Institute

9:45

Practical Usage of KRIs and QTLs in Clinical Trials

Artem Andrianov, Ph.D.
CEO
Cyntegrity

10:30

Networking and Refreshment Break

11:00

Is It Even Possible to Oversee CROs In the RBM Model?

Esther M. Huffman O’Keefe
Associate Director, Monitoring, Global Clinical Operations
Regeneron

Regulatory Compliance in RBM

11:45

Utilizing RBM to Oversee Critical Vendor Data

Laureen Dorschel
Clinical Study Risk Manager, Clinical Data Operations, Technology and Standards,
UCB Biosciences, Inc.

John (Jay) Daly
Clinical Study Risk Manager, Clinical Data Operations, Technology, and Standards
UCB Biosciences, Inc.

12:30

Networking Luncheon

1:30

PANELPost Implementation of RBM — Regulatory Inspections — What Have We Learned?

MODERATOR:

Steve Young
Chief Operations Officer
CluePoints

PANELISTS:

Lisa G. Berdan, PA, MHS
Director, Global MegaTrials
Duke Clinical Research Institute

Lewis Hower
Director, Risk Management, Central Monitoring
Janssen

Phi Tat
Central Monitor (Sr. Associate)
Pfizer

Gain Insight into Future Trends in RBM

2:15

PANELThe Latest and Greatest Brought to You by TransCelerate

MODERATOR:

Andy Lawton
Director
Risk-Based Approach Ltd

PANELISTS:

Esther M. Huffman O’Keefe
Associate Director, Monitoring, Global Clinical Operations
Regeneron

Phi Tat
Central Monitor (Sr. Associate)
Pfizer

Mary Arnould
Director/RBM Lead, Clinical Science Operations
Astellas

3:00

Emerging Trends in Source Data Review (SDR) vs. Source Data Verification (SDV)

Mary Arnould
Director/RBM Lead, Clinical Science Operations
Astellas

3:30

Close of Conference