Skip navigation

DAY ONE Thursday, November 2, 2017

7:30

Main Conference Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Suzanne Lukac
Director, Risk-Based Monitoring Implementation
Merck

Strategies for Complying with
Evolving ICH and FDA Regulations

8:45

What You Need to Know About the Revised ICH E6 (R2) Regulations

Lynne Brophy
Senior CRA
Esperion

Joseph Gotowko
Assistant Director, Quality Systems – Quality Risk Management (QRM)
AbbVie

9:30

Beyond RBM — How Intelligent Analytics Are Being Used to Drive Regulatory Inspections and Support ICH Compliance

Lynne Cesario
Director, Risk Based Monitoring Program Lead
Pfizer Inc

Steve Young
Chief Operations Officer
CluePoints

10:15

Networking and Refreshment Break

10:45

Reduce the Number of FDA and MHRA Inspection Findings Using
Risk-Based Trial Management and Monitoring

Jonathan Helfgott
Former Associate Director, Risk Science, Intelligence & Prioritization, FDA;
Coordinator, Regulatory Science Program, Johns Hopkins University

11:30

Choose Between Two 60-Minute Breakout Options (1-2)

Life sciences organizations are at different levels of implementing RBM. Some are at the beginning of the implementation process while others are more entrenched and using it on a day-to-day basis with their studies. Join one of two tailored sessions that best suits your current RBM needs!

1Refresher on RBM — How to Develop and Operationalize a Risk-Based Monitoring Plan

Elizabeth Robinson, RN, MSHS
Executive Director, Clinical Compliance and Operations
Horizon Pharma

2In the Trenches of RBM — Overcoming Challenges with System Integration

Angie Maurer, RN, BSN, MBA, CCRA
Clinical Operations Consultant
Gilead Sciences

12:30

Networking Luncheon

Devise Quality-Based and Data Driven
Approaches to Risk-Based Monitoring

1:30

‘C’ the Monitoring Future through Compliance and Cloud Computing

Lori Convy
Director, Strategic Monitoring
Medidata

Andy Lawton
Consultant
Risk Based Approach Ltd.

2:15

RBM Risk Assessment — What Risks Are We Assessing from the Patient,
Study, Site and Sponsor Perspectives?

Jules T. Mitchel, PhD
President
Target Health

3:00

Networking and Refreshment Break

3:30

Proactive Quality Risk Management — Key Performance Indicators

Stephen Potter
Director Quality Risk Management
Pfizer Inc

4:15

Unlocking Value from Performance and Operational Data Including a Centralized Statistical Approach

Nithiya Ananthakrishnan
CEO
Algorics

5:00

Are We Ready for Artificial Intelligence (AI) in RBM?

Jennifer Bush
Director, Life Sciences Product Strategy
Oracle Health Sciences Global Business Unit

5:15

Close of Day One

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

DAY TWO Friday, November 3, 2017

7:30

Continental Breakfast

8:00

Chairperson’s Review of Day One

Suzanne Lukac
Director, Risk-Based Monitoring Implementation
Merck

8:15

Meeting of the Minds — A Site, Sponsor and CRO Perspective

CROs:

Kristin Mauri
Global Head, Risk Based Monitoring
Bioclinica

Megan DiGregorio-Fecteau
Director, Central Monitoring North America
PRA Health Sciences

Sponsors:

Jeannett Dimsits
Senior Director Trial Management Anchor
Novo Nordisk A/S

Susanne Witzke
Competency Development Specialist, Trial Management Anchor
Novo Nordisk A/S

Site:

Speaker TBA

Innovative Technology and System
Enhancements to Optimize Trial Efficiency

9:15

Using Technology to Minimize Risk and Comply with ICH GCP Guidelines

Vanesa Castillo
Senior Director Monitoring & Data Flow Optimization,
Covance

10:00

PANEL The TransCelerate Model Approach

Moderator:

Steve Young
Chief Operations Officer
CluePoints

Panelists:

Suzanne Lukac
Director, Risk-Based Monitoring Implementation
Merck

Lynne Cesario
Director, Risk Based Monitoring Program Lead
Pfizer Inc

10:45

Networking and Refreshment Break

11:15

Budgeting Clinical Trials When RBM Is Applied

Brian Nugent
Executive Director Clinical Solutions and Compliance
Ultragenyx Pharmaceutical

12:00

Networking Luncheon and Tool-Box Exchange

Attendees have the opportunity to participate in a tool-box exchange during lunch. Provide a helpful tool (i.e., a template, checklist, training materials, tools, workarounds, etc.) that your peers could benefit from utilizing themselves. Participants have the opportunity to collaborate with their peers during this robust dialogue and exchange. All collected materials during this tool-box exchange will be available in the post-conference compendium.

1:15

How Has Outsourcing Your RBM Changed Over the Years

Kristin Mauri
Global Head, Risk Based Monitoring
Bioclinica, Inc.

2:00

RBM ROUNDABOUT The Three Ingredients for A Successful Change Management

Moderator:

Joseph Gotowko
Assistant Director, Quality Systems – Quality Risk Management (QRM)
AbbVie

2:45

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE Thursday, November 2, 2017

7:30

Main Conference Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Suzanne Lukac
Director, Risk-Based Monitoring Implementation
Merck

Strategies for Complying with
Evolving ICH and FDA Regulations

8:45

What You Need to Know About the Revised ICH E6 (R2) Regulations

Lynne Brophy
Senior CRA
Esperion

Joseph Gotowko
Assistant Director, Quality Systems – Quality Risk Management (QRM)
AbbVie

9:30

Beyond RBM — How Intelligent Analytics Are Being Used to Drive Regulatory Inspections and Support ICH Compliance

Lynne Cesario
Director, Risk Based Monitoring Program Lead
Pfizer Inc

Steve Young
Chief Operations Officer
CluePoints

10:15

Networking and Refreshment Break

10:45

Reduce the Number of FDA and MHRA Inspection Findings Using
Risk-Based Trial Management and Monitoring

Jonathan Helfgott
Former Associate Director, Risk Science, Intelligence & Prioritization, FDA;
Coordinator, Regulatory Science Program, Johns Hopkins University

11:30

Choose Between Two 60-Minute Breakout Options (1-2)

Life sciences organizations are at different levels of implementing RBM. Some are at the beginning of the implementation process while others are more entrenched and using it on a day-to-day basis with their studies. Join one of two tailored sessions that best suits your current RBM needs!

1Refresher on RBM — How to Develop and Operationalize a Risk-Based Monitoring Plan

Elizabeth Robinson, RN, MSHS
Executive Director, Clinical Compliance and Operations
Horizon Pharma

2In the Trenches of RBM — Overcoming Challenges with System Integration

Angie Maurer, RN, BSN, MBA, CCRA
Clinical Operations Consultant
Gilead Sciences

12:30

Networking Luncheon

Devise Quality-Based and Data Driven
Approaches to Risk-Based Monitoring

1:30

‘C’ the Monitoring Future through Compliance and Cloud Computing

Lori Convy
Director, Strategic Monitoring
Medidata

Andy Lawton
Consultant
Risk Based Approach Ltd.

2:15

RBM Risk Assessment — What Risks Are We Assessing from the Patient,
Study, Site and Sponsor Perspectives?

Jules T. Mitchel, PhD
President
Target Health

3:00

Networking and Refreshment Break

3:30

Proactive Quality Risk Management — Key Performance Indicators

Stephen Potter
Director Quality Risk Management
Pfizer Inc

4:15

Unlocking Value from Performance and Operational Data Including a Centralized Statistical Approach

Nithiya Ananthakrishnan
CEO
Algorics

5:00

Are We Ready for Artificial Intelligence (AI) in RBM?

Jennifer Bush
Director, Life Sciences Product Strategy
Oracle Health Sciences Global Business Unit

5:15

Close of Day One

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

DAY TWO Friday, November 3, 2017

7:30

Continental Breakfast

8:00

Chairperson’s Review of Day One

Suzanne Lukac
Director, Risk-Based Monitoring Implementation
Merck

8:15

Meeting of the Minds — A Site, Sponsor and CRO Perspective

CROs:

Kristin Mauri
Global Head, Risk Based Monitoring
Bioclinica

Megan DiGregorio-Fecteau
Director, Central Monitoring North America
PRA Health Sciences

Sponsors:

Jeannett Dimsits
Senior Director Trial Management Anchor
Novo Nordisk A/S

Susanne Witzke
Competency Development Specialist, Trial Management Anchor
Novo Nordisk A/S

Site:

Speaker TBA

Innovative Technology and System
Enhancements to Optimize Trial Efficiency

9:15

Using Technology to Minimize Risk and Comply with ICH GCP Guidelines

Vanesa Castillo
Senior Director Monitoring & Data Flow Optimization,
Covance

10:00

PANEL The TransCelerate Model Approach

Moderator:

Steve Young
Chief Operations Officer
CluePoints

Panelists:

Suzanne Lukac
Director, Risk-Based Monitoring Implementation
Merck

Lynne Cesario
Director, Risk Based Monitoring Program Lead
Pfizer Inc

10:45

Networking and Refreshment Break

11:15

Budgeting Clinical Trials When RBM Is Applied

Brian Nugent
Executive Director Clinical Solutions and Compliance
Ultragenyx Pharmaceutical

12:00

Networking Luncheon and Tool-Box Exchange

Attendees have the opportunity to participate in a tool-box exchange during lunch. Provide a helpful tool (i.e., a template, checklist, training materials, tools, workarounds, etc.) that your peers could benefit from utilizing themselves. Participants have the opportunity to collaborate with their peers during this robust dialogue and exchange. All collected materials during this tool-box exchange will be available in the post-conference compendium.

1:15

How Has Outsourcing Your RBM Changed Over the Years

Kristin Mauri
Global Head, Risk Based Monitoring
Bioclinica, Inc.

2:00

RBM ROUNDABOUT The Three Ingredients for A Successful Change Management

Moderator:

Joseph Gotowko
Assistant Director, Quality Systems – Quality Risk Management (QRM)
AbbVie

2:45

Close of Conference