October 11-12, 2021
Online Livestream
2nd REMS VirtualSummit
Next-Gen Partnership & Technology Strategies to Advance Drug Safety Programs

REMS compliance depends on your skill at coordinating diverse stakeholders, preparing for inspections, and successfully predicting and minimizing risk. Are your operational goals realistic for the needs of your REMS program? Do you have everything you need for communicating with HCPs, pharmacies, and patients?

Now featuring an all-new agenda built specifically around the questions most urgently requested by your peers, DGE’s 2nd REMS Virtual Summit (October 11-12, 2021) provides unprecedented depth about setting timetables, implementing effective assessments, and juggling FDA submissions and modifications. You cannot afford to miss these never-before-shared insights from industry leaders, representing Pfizer, Janssen, GSK, Merck, Walgreens, Alexion and many more!

Top Reasons to Attend
  • Strategies for building rapid response teams that handle FDA requests quickly and accurately
  • Understand new insights for adapting to issues that arise outside the guidelines
  • Detailed case studies about spotting and overcoming challenges to REMS implementation
  • Methods for handling multiple submission and modification deadlines while reducing stakeholder burden
  • All-new agenda built on feedback and requests from REMS leaders just like you!
Who Should Attend

This event is designed for pharmaceutical, biotech, and medical device professionals responsible for:

  • REMS
  • Drug / Product Safety
  • Clinical Risk Management
  • Quality Assurance
  • Surveillance
  • Pharmacovigilance
  • Risk Management
  • REMS service providers
  • Clinical Data Management
  • Clinical Operations
  • Clinical Affairs
  • Legal
  • Regulatory Affairs / Compliance
  • Medical Direction
  • Life Cycle Management
  • Epidemiology / Pharmacoepidemiology
  • Pharmacist
  • Health Scientist
  • Medical affairs
  • Quality management and Compliance
  • Legal
  • IT
  • Software Development and Technology
  • Regulatory affairs
  • Medical Affairs Operations & Risk Management
  • Program Management
  • Medical Director
  • Project Manager
  • Global Safety
  • Compliance
  • Patient Access
  • Market Access
  • Research

This Program Is Also Of Interest To:

  • Technology vendors
  • Data management services
  • Pharmacovigilance / drug surveillance specialists
  • Drug safety service providers
  • CROs
Event Sponsors
New Topics
Featured Speakers
Ana Carolina, da Silva Macarenco
Risk Management Fellow
Annette Stemhagen, DrPH, FISPE
SVP, Chief Scientific Officer
Brian Malkin
FDA and IP Partner
Colleen Walsh
Senior Director, Regional Safety Excellence
Eleni Samaras Allen
Scientific Director, REMS Lead
Gerard Appert
Jamie Wilkins
Head, Risk Management Center of Excellence (RMCoE)
John Klimek
Senior VP, Standards and Information Technology
Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs
Kellie Taylor
Senior Director Regulatory Affairs
Kyle Irwin
Operations Lead REMS
Liza Rodriguez
Associate Director, Global Risk Management, US REMS Strategy
Bristol Myers Squibb
Marc DeLuca
US Risk Management Lead
Matt Page
Post Marketing Safety Studies Team Lead
Michele Davidson
Senior Manager, Pharmacy Technical Standards Development & Policy, Government Relations
Michelle Shannon
Senior Advisor, Pharmacovigilance and Product Safety Team
Nancy Dubois
Associate Director, US Local Safety Officer
Nilima Justice
Global Therapeutics Areas Head
Pritam Dodeja
Director, IT Business Partner
Raphael Elmadjian Pareschi
Pharmacovigilance Assistant Director
Reema Mehta
Vice President, Head of Risk Assessment and Management
Vraj Patel
Medication Error Pharmacovigilance and Risk Management Fellow
Event Schedule
Do you know what is happening with your REMS department growth? Two academically partnered Risk Management Fellowship Program leaders and former FDA REMS directors will have a fireside chat discussing:
  • Current experiences with Risk Management Fellowship Program development, recruitment and operations
  • Structured risk management education
  • Analyze your current structure to evaluate readiness for a potential Fellowship or training program
  • Experience of current Fellows
The specialty pharmacy provider must demonstrate the flexibility to support REMS requirements that come in all shapes and sizes. The more a specialty pharmacy can understand the needs of a specific manufacturer program, the greater its opportunities will be for inclusion in a distribution model that requires a REMS.
  • Demonstrate a commitment to the success of the program and the product
  • Understand the manufacturer’s perspective and potential risk associated with non-compliance
  • Exhibit the ability to interact with stakeholders across a variety of touch points
Half of REMS assessments do not include all of the information requested in FDA assessment plans. Deeper awareness of these regulatory expectations can help you ensure accuracy of your evidence based assessments.
  • Develop alternative methods for more accurate assessments
  • Implement standardized formats for reports
  • Employ resources to meet required timeframes
Should you use a third-party vendor to write or manage your REMS? New technologies can make your processes far more efficient, but these are not “plug-and-play”: you will need strong and reliable relationships with all your service providers.
  • Ensure all stakeholders have up to date information for proper drug distribution
  • Pinpoint techniques that minimize the risk
  • Explore new tools for drug distribution
Implementing and reporting patient and prescriber KAB surveys are essential to evaluation of REMS effectiveness. While you can build on lessons learned, no survey approach is exactly the same and new challenges constantly arise that affect survey implementation. Such challenges can derive from the REMS Program or from the survey process itself. You will be best-prepared for your own REMS KAB survey program by learning from others who have confronted the toughest challenges and overcome them.
  • Implement KAB surveys with ease
  • Hear issues that you can come across in KAB survey development and implementation
  • Learn key lessons from responses that succeeded in overcoming these challenges
  • Build adaptable systems capable of rapid response
McKesson’s recent departure from the REMS space has brought with it novel challenges for pharmacies. NCPDP has suggested initiatives to counteract these, but your teams will need to learn and adapt quickly as the marketplace changes. This session describes new processes and approaches that are less burdensome for pharmacists who have to interface with REMS.
  • Discuss opportunities to incorporate REMs programs into pharmacy workflow
  • Specify and adapt to the changes caused by departure of the “switch” pharmacy management system
  • Work with your retail pharmacist with ease
It is not uncommon for sponsors to want to submit changes to FDA post-approval, but to refrain from this due to fear of unexpected feedback. Submitting changes is a fact of life and your team must be comfortable and proficient with it.
  • Make certain to not hinder innovation to reduce stakeholder burden
  • Navigate timing for submissions
  • Handle change submissions and anticipate FDA feedback
Are your programs able to meet the goals as defined in the REMS? Or were the goals put into place unrealistic?
  • Handle FDA requests quickly and with accuracy
  • In depth look at REMS modifications
  • Manage the unpredictability of contractors
Communication about the risks of medicines is not a new concept, but the tactics and technology are ever-changing. Risk professionals need to prep for constant interactions with patients, HCPs, policymakers, and the general public in order to manage risks with medicines appropriately and reduce patient harm.
  • Increase transparency and improve awareness in your communication
  • Explore how to put established principles into practice and to experiment with new approaches
  • Consistently distribute informational materials through professional societies for communication transparency
This case study will review the key components of the Soliris REMS and describe methods by which the marketing authorization holder has revised components of the REMS to increase compliance.
  • Explore the challenges experienced with implementation of the REMS program in the current US healthcare system
  • Hear potential future improvements to increase REMS compliance
  • Avoid red flags and penalties with effective organization techniques
It is the responsibility of your entire team to make sure REMS are properly implemented and that all information in assessment reports is accurate. Do you have the necessary training and oversight systems in place?
  • Ensure compliance is followed within REMS requirements
  • Prepare for REMS inspections which are highly regulated as well as those which are non regulated
  • Learn from past instances of mistakes and failure
Enhancing patient safety and minimizing professional liability risks go hand in hand. You can reduce the risk – and the patient’s “fear factor” – by getting rigorous patient monitoring techniques in place.
  • Understand the most feasible techniques for upgrading patient monitoring during COVID
  • Hear ways to minimize risk and decrease the burden on the patient
  • Network and learn from patient advocates, caregivers, and support groups
  • Breakdown the quality of education materials and how the level of interaction
Register Now

This window is secured by 256 bit encryption on a PCI compliant network. Click here to view this window in its own page.

Subscribe to Conference Updates
Join our e-newsletter list to follow closely all news.
Event Partners
Contact Us