Agenda – 10th Risk Evaluation & Mitigation Strategies Summit

  • Day 1
  • Day 2

Day 1

 Monday, January 29, 2018

8:45AM – 9:00AM

Chairperson’s Opening Remarks
Emily Freeman, Ph.D., Director, Risk Management Sciences, ABBVIE

9:00AM – 10:00AM

REMS Carousel Discussion Exercise
Emily Freeman, Ph.D., Director, Risk Management Sciences, ABBVIE
Cheryl Renz, M.D., Head, Benefit-Risk Management Pharmacovigilance and Patient Safety (PPS), ABBVIE

10:00AM – 10:45AM

Hot off the Press: New FDA Initiatives and Guidelines
Annette Stemhagen, MPH, DrPH, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, UNITED BIOSOURCE CORPORATION

10:45AM – 11:15AM

Networking Break

11:15AM – 11:45AM

Integrate Consumer and Health Information Technologies Within the Primary Care Practice to Promote Safe Medication Use
Stacy Cooper Bailey, Ph.D., MPH, Assistant Professor, Division of Pharmaceutical Outcomes and Policy, UNC ESHELMAN SCHOOL OF PHARMACY

11:45AM – 12:15PM

Enhance Patient Understanding and Engagement by Knocking Down Barriers to Proper Medication Use
Michael S. Wolf, Ph.D., MPH, Professor, Medicine and Learning Sciences, Associate Chair, Department of Medicine, Associate Division Chief, Research, General Internal Medicine and Geriatrics, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY

12:15PM – 1:15PM

Luncheon

1:15PM – 2:15PM

Reduce the Burden on Pharmacists and HCPs Through Interoperable Technologies
John Klimek, R.Ph., Senior Vice President, Standard and IT, NCPDP

1:45PM – 2:15PM

Evaluate Patient Understanding of Risks: The Value of Cognitive Vs. Metacognitive Methods
Ruth S. Day, Ph.D., Director, Medical Cognition Lab, Senior Fellow, Center for Aging and Human Development, DUKE UNIVERSITY

2:15PM – 3:00PM

Benefit, Risk, Removals, and Corrections: Putting the Pieces Together
Adam E. Saltman, M.D., Ph.D., FACS, FACC, FACP, FAHA, Medical Officer, CDRH Office of Compliance, FOOD AND DRUG ADMINISTRATION

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

CASE STUDY: Examine a Real-World Pharmaceutical Benefit-Risk Management
Larry Risen, MBA, President and CEO, BIOTRAK RESEARCH

4:15PM – 5:15PM

Overview of Recent FDA Guidances Impacting REMS
Gita Toyserkani, Pharm.D., MBA, Regulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FOOD AND DRUG ADMINISTRATION
Suzanne Robottom, Pharm.D., Regulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FOOD AND DRUG ADMINISTRATION

5:15PM – 5:45PM

CO*RE and the Opioid REMS: Significant Learnings From an Eight-Year CE/CME Collaboration
Cynthia Kear, Lead, Collaboration Management, CO*RE

5:45PM – 6:15PM

Integrate REMS Requirements With the EHR and Provider Workflows
Dean T. Parry, RPH, Assistant Vice President, Clinical Informatics, Care Support Services, GEISINGER HEALTH SYSTEM


Day 2

 Tuesday, January 30, 2018

8:00AM – 8:45AM

Continental Breakfast

8:45AM – 9:00AM

Chairperson’s Recap of Day One
Emily Freeman, Ph.D., Director, Risk Management Sciences, ABBVIE

9:00AM – 9:45AM

Integrating an Existing REMS Program Into Your Organization Following an Acquisition
Kim H. Bullano, B.S., Pharm.D., Risk Management Team Lead, SHIRE

9:45AM – 10:30AM

Incorporating HIT Within REMS Programs to Address REMS Stakeholder Burden
Paul Sheehan, Executive Director, Head of U.S. REMS, CELGENE CORPORATION

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Compare and Contrast REMS Program Models and Assessment Reporting Aspects
Nathan Kopper, Pharm.D., Director, REMS Consulting and Strategy, MCKESSON
Pat daCosta, Pharm.D., REMS Sr. Product Manager, RELAYHEALTH

11:45AM – 12:30PM

Applying the RE-AIM Framework for REMS Assessments
May Chan-Liston, Director, REMS Strategy and Policy, CELGENE CORPORATION

12:30PM – 1:30PM

Luncheon

2:15PM – 3:00PM

Develop and Deliver Effective Evaluation of Risk Minimization Measures
Michael von Forstner, Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE

3:00PM – 3:30PM

Network Break

3:30PM – 4:15PM

Incorporate Novel Approaches Into Real-World Data (RWD) to Evaluate Risk Minimization (RM) Interventions
Rachel Sobel, Senior Director, Epidemiology - Group Lead Global Innovative Pharma, PFIZER

4:15PM – 5:00PM

PANEL: Examine Best Practices in Developing and Operationalizing Shared REMS
Kevin Holman, Senior Director, Drug Regulatory Affairs, ACTELION
Deb Tiffany, Director, Global Risk Management Product Lead, Process Analyst, Worldwide Safety and Regulatory, PFIZER