Innovative Approaches, Technology, and
Partnerships to Ensure Your REMS Strategy is
Optimized, Patient-Centric, and FDA Compliant

On-Demand Content | Virtual Event

AGENDA – ALL TIMES ARE IN EASTERN TIME

Come visit our virtual lobby and connect with fellow attendees. You can chat, video, and even make a list of the people you want to meet and the knowledge you’re looking to gain through our bespoke 1:1 match-making services.
Jonathan Banchs
Director of Content and Experience
MOMENTUM EVENTS

Sherice Mills
Executive Director, Risk Management U.S. and Canada
JAZZ PHARMACEUTICALS

Jacqueline Gerena
Director, Program Management (REMS Program)
AIMMUNE THERAPEUTICS
  • 14 years into REMS Programs, evolution and upgrades
  • Understanding the challenges that have been overcome to future-proof your strategies and the need to continue to work towards patient centricity
  • Factors that have helped the development of the REMS Programs
  • Risk Minimization measures like RPM and RiskMap compared to REMS
Panelists:

Jamie Wilkins
Head- Risk Management Center of Excellence- Worldwide Safety
PFIZER

Eleni Allen
Director, REMS Strategy and Execution
GSK

Anupam Agarwal
Global Executive Director, Drug Safety
ZOGENIX
  • Take time in teaching REMS to your peers and collaborators
  • Improve the REMS Program due to commitment from your colleagues that are not directly involved but are key elements to the success of your program
  • Share the knowledge, do not hesitate to let people know about the importance of REMS
Jaqueline Gerena
Director, Program Management (REMS Program)
AIMMUNE THERAPEUTICS

Madalo Maliro
Senior Manager, REMS Program
AIMMUNE THERAPEUTICS
  • Understand the scope of every stakeholder involved in REMS
  • Learn how by working together we can improve the REMS Program for everyone involved
  • Increase the success rate of your REMS Programs by taking every stakeholder into consideration
  • Stakeholder engagement pros and cons
Moderator:
Sherice Mills
Senior Director – Benefit Risk Management
JAZZ PHARMACEUTICALS

Panelists:

Owen Muir – Physician Perspective
Founder and Chief Service Officer
BROOKLYN MINDS

Deborah Collyar – Patient Perspective
President
PATIENT ADVOCATES IN RESEARCH

Michele Davidson – Pharmacie Perspective
Sr. Mgr, Pharmacy Technical Standards, Development and Policy
WALGREENS

Suzanne Marinello
Associate Director REMS and Patient Support
OTSUKA

Jennifer Reinert
Director, Risk Management Product Lead, Worldwide Safety and Regulatory
PFIZER
  • Transition from Individual RLD REMS to a Single Shared REMS Program
  • Factors to consider in Negotiations and Alternatives
  • Key factors for consideration during the REMS development and implementation phase
  • REMS Compliance and Inspection Readiness
Jaylaxmi Nalawade
Associate Director – Pharmacovigilance and REMS
LUPIN PHARMACEUTICALS

Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs
AMNEAL PHARMACEUTICALS

Kishore Gopu
Senior Director, REMS Operations
TEVA PHARMACEUTICALS
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time, not only with the speakers but with your industry peers. This is not a live chat or faceless group. This is an opportunity to have an engaged conversation with your industry counterparts and conference speakers.
  • Learn why REMS is becoming ever more important in mental health treatments
  • The rise of psychedelic and interventional psychiatry presents barriers and opportunities with REMS
  • An innovative approach of EHR-centric REMS streamlines clinic workflows and enables new ways to assess REMS programs
  • The EHR-first model allows us to push the boundary using real-world data, AI and NLP, and novel digital data streams
Jimmy Qian
Co-founder/COO 
OSMIND

Carlene MacMillan 
Medical Director
OSMIND
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time, not only with the speakers but with your industry peers. This is not a live chat or faceless group. This is an opportunity to have an engaged conversation with your industry counterparts and conference speakers.
Come visit our virtual lobby and connect with fellow attendees. You can chat, video and even make a list of the people you want to meet and the knowledge you’re looking to gain through our bespoke 1:1 match-making services.
Jonathan Banchs
Director of Content and Experience
MOMENTUM EVENTS

Sherice Mills
Executive Director, Risk Management U.S. and Canada
JAZZ PHARMACEUTICALS

Jacqueline Gerena
Director, Program Management (REMS Program)
AIMMUNE THERAPEUTICS
Jamie Wilkins
Head- Risk Management Center of Excellence- Worldwide Safety
PFIZER
  • Make sure your patients understand the risks and the benefits of the REMS program
  • Share the information and provide platforms so your patients can share feedback that can make the experience improve
  • Invest in the most important aspect of the REMS – the well-being of your patients
Catina O’Leary
President & CEO
HEALTH LITERACY MEDIA
  • Drive your REMS Program targeting the patient outcome as the priority
  • Facilitate to the patient all the tools and information they require and need to feel a central piece of the REMS Program
  • Focus the strength of the different stakeholders to focus on the patient centricity success
Deborah Collyar
President
PATIENT ADVOCATES IN RESEARCH
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time, not only with the speakers but with your industry peers. This is not a live chat or faceless group. This is an opportunity to have an engaged conversation with your industry counterparts and conference speakers.
  • Discuss if the FDA decision was the “right call” by relaxing requirements and tests for the REMS Programs
  • Analyze the effects and consequences of this measurement moving forward for all the stakeholders involved
  • Explore the different paths leading to this decision and explore the possible outcomes of more relaxed regulated REMS Programs
Nancy Dubois
Senior Manager, Risk Evaluation and Mitigation Strategies
ALEXION
  • Roadmap to REMS Success
  • Master the processes and maintain a very clear course of action while keeping all the stakeholders up to date with the information
Kyle Irwin
Operations Lead – REMS and Risk Management
JOHNSON & JOHNSON 

Sheline Way
Senior Manager, REMS Operations
TEVA PHARMACEUTICALS
  • Extract all the important information deriving from the Single, Shared System REMS with Best Practices on how to successfully work the shared system REMS
Chantal Phillips
Former Risk Evaluation and Mitigation Strategies (REMS) Coordinator Team Lead
FORMER FDA
A safe space to talk candidly through your challenges, new tools/tactics. Dedicated VIDEO Q&A time, not only with the speakers but with your industry peers. This is not a live chat or faceless group. This is an opportunity to have an engaged conversation with your industry counterparts and conference speakers.