Agenda – 12th REMS Summit

  • Main Conference Day One
  • Main Conference Day Two

Main Conference Day One

 

9:00 – 9:15

Co-Chairpersons' Opening Remarks
Reema Mehta, Head of Risk Management and Safety Surveillance Research, Pfizer
Annette Stemhagen, Sr Vice President, Safety, Epidemiology, Registries and Risk Management, UBC

9:15 – 10:00

A Standardized Approach to REMs Using NCPDP Standards
Michele Davidson, Senior Manager, Pharmacy Technical Standards, Development and Policy, Government Relations, Walgreens Co

10:45 – 11:15

Networking Break

11:15 – 12:00

Design an Orderly REMS Program With Implementational Science
Elaine Morrato, Associate Dean for Public Health Practice, Colorado School of Public Health

12:00 – 12:45

Panel: Development of a Shared System REMS
Elaine Lippman, Regulatory Counsel, FDA

12:45 – 1:45

Luncheon

1:45 – 2:30

Process Automation and Content Management Solutions for Risk Management
Sharon Reid, Risk Management Product Lead, Pfizer

2:30 – 3:15

REMS Alignment With European Counterparts Such As Risk Management Plans
Romana Hosain, Head of Risk Management, Regeneron

3:15 – 3:45

Networking Break

3:45 – 4:30

Celgene REMS Innovations
Duyen Mai, Director, US REMS Strategy & Policy, Celgene

4:30 – 5:15

Recognize the Varying Case to Case Perspective From Patients
Seth Morgan, Chairman and Advocate, Maryland Government Relations Committee

5:15 – 5:15

Day One Concludes


Main Conference Day Two

 

9:00 – 9:15

Co-Chairpersons' Opening Remarks and Recap of Day One
Reema Mehta, Head of Risk Management and Safety Surveillance Research, Pfizer
Annette Stemhagen, Sr Vice President, Safety, Epidemiology, Registries and Risk Management, UBC

9:15 – 10:00

How an Acquisition Will Affect Your REMS Program
Jacqueline Gerena, Director, REMS Program and Drug Safety Compliance, Titan Pharmaceuticals

10:00 – 10:45

Opioid REMS and the CO*RE Initiative
Cynthia Kear, Senior Vice President, California Academy of Family Physicians

10:45 – 11:30

Networking Break

11:30 – 12:15

NCPDP New Standards and REMS, Working Group Updates and Innovation at Work Within National Council for Prescription Drug Programs
John Klimek, Senior Vice President Standards and Information Technology, NCPDP

12:15 – 1:15

Luncheon

1:15 – 2:00

Planning for a first REMS in a clinical-stage medium-size enterprise
Marc Morris, Vice President, Safety and Pharmacovigilance, Apellis Pharmaceuticals

2:00 – 2:45

Biotechs Standpoint on Patients Perspective in REMS Advancement
Tricia Mullins, Senior Director, Global Patient Advocacy, Halozyme

3:30 – 3:30

Co-Chairpersons' Closing Remarks
Reema Mehta, Head of Risk Management and Safety Surveillance Research, Pfizer
Annette Stemhagen, Sr Vice President, Safety, Epidemiology, Registries and Risk Management, UBC