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Past event: Risk Evaluation and Mitigation Strategies (REMS) Summit

Convening those in the risk mitigation and evaluation space to help discuss new innovations in risk management operations to ensure patient engagement, open communications and advanced efficacy of REMS models.

The 12th REMS Summit convenes pharma, FDA, healthcare providers, and patient advocates to delve into specific topics to enhance the understanding of when REMS are necessary the elements that need to be included in the REMS needed for their product, as well as details required for submission. Our adept speaking faculty will arm you with proven strategies to facilitate benefit-risk counseling, optimize REMS operations through streamlined health system integration, leverage interoperable technologies for consistent communication, and increase patient safety through cross-functional collaboration.

Top Five Reasons to Attend:

  1. To assess REMS efficacy with proven methods from industry professionals
  2. Complying with regulations pertaining to standardization and evaluation
  3. Collaborate with industry leaders on innovative approaches for REMS design, implementation, and solutions
  4. Increase knowledge and awareness of upcoming REMS technologies, innovation and regulatory changes
  5. Discussing the challenges of recent FDA guidelines impacting REMS

Who Should Attend:

This event is ideal for professionals from payers and pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas:
  • REMS
  • Risk Management
  • Pharmacovigilance/Surveillance
  • Quality Assurance
  • Drug/Product Safety
  • Clinical Risk Management
  • Lifecycle Management
  • Regulatory Affairs/Legal/Compliance
  • Clinical Affairs
  • Clinical Data Management
  • Clinical Operations
  • Clinical Risk Management Compliance
  • Epidemiology/Pharmacoepidemiology
  • Marketing


  • Michele V. Davidson, Senior Manager, Pharmacy Technical Standards, Development and Policy, Government Relations, WALGREENS CO
  • Jacqueline Gerena, Director, REMS Program and Drug Safety Compliance, TITAN PHARMACEUTICALS
  • Kevin Holoman, Head, US Safety Risk Management, JOHNSON AND JOHNSON
  • Romana Hosain, Head of Risk Management, REGENERON PHARMACEUTICALS, INC.
  • Cynthia Kear, MDiv, Senior Vice President, CALIFORNIA ACADEMY OF FAMILY PHYSICIANS
  • Duyen Mai, Director, U.S. REMS Strategy and Policy, CELGENE
  • Reema Mehta, Head of Risk Management Center of Excellence, PFIZER INCORPORATED
  • Seth Morgan, Chair and Advocate, NATIONAL MULTIPLE SCLEROSIS SOCIETY
  • Elaine H. Morrato, Special Government Employee FDA, Associate Dean for Public Health Practice, COLORADO SCHOOL OF PUBLIC HEALTH
  • Marc Morris, VP, Safety and Phamacovigilance, APELLIS PHARMACEUTICALS, INC
  • Tricia Mullins, Senior Director, Global Patient Advocacy & Medical Education, HALOZYME THERAPEUTICS, INC
  • Jaylaxmi Nalawade, Associate Director, Pharmacovigilance and REMS, LUPIN SOMERSET
  • Anita Putcha, Head US Safety and Risk Management, NOVARTIS PHARMACEUTICALS
  • Sharon Reid, Risk Management Product Lead, PFIZER INCORPORATED
  • Annette Stemhagen, MPH, DrPH,, Sr Vice President, Safety, Epidemiology, Registries and Risk Management, UBC
  • Willis H. Thomas, Ph.D., PMP, CPT, Director, Training and Development, AKORN, INC

Please fill in your name and email to receive the Conference Agenda of this event.


Key Bridge Marriott
1401 Lee Highway, 22209
Arlington, VA, USA

To make reservations, please call 1 (800) 228-9290 or (703) 524-6400 and request the negotiated rate for this 12th REMS Summit. To make reservations online click here.
Event details
Organizer : ExL
Event type : Conference
Reference : ASDE-21710