Event Sponsors
Featured Speakers
Ana Carolina, da Silva Macarenco
Risk Management Fellow
PFIZER
Annette Stemhagen, DrPH, FISPE
SVP, Chief Scientific Officer
UBC
Brian Malkin
FDA and IP Partner
MCDERMOTT WILL & EMERY
Colleen Walsh
Senior Director, Regional Safety Excellence
ALEXION
Eleni Samaras Allen
Scientific Director, REMS Lead
GLAXOSMITHKLINE
Gerard Appert
COO
COMPLIANCE ARCHITECTS
Jamie Wilkins
Head, Risk Management Center of Excellence (RMCoE)
PFIZER
John Klimek
Senior VP, Standards and Information Technology
NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS (NCPDP)
Kal Elhoregy
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs
AMNEAL PHARMACEUTICALS
Kellie Taylor
Senior Director Regulatory Affairs
REGENERON
Kyle Irwin
Operations Lead REMS
JANSSEN
Liza Rodriguez
Associate Director, Global Risk Management, US REMS Strategy
BRISTOL MYERS SQUIBB
Marc DeLuca
US Risk Management Lead
SANOFI
Matt Page
Post Marketing Safety Studies Team Lead
TAKEDA
Michele Davidson
Senior Manager, Pharmacy Technical Standards Development & Policy, Government Relations
WALGREENS
Michelle Shannon
Senior Advisor, Pharmacovigilance and Product Safety Team
CVS
Nancy Dubois
Associate Director, US Local Safety Officer
ALEXION
Nilima Justice
Global Therapeutics Areas Head
ASTRAZENECA
Pritam Dodeja
Director, IT Business Partnership supporting CAR T Risk Management
BRISTOL MYERS SQUIBB
Raphael Elmadjian Pareschi
Pharmacovigilance Assistant Director
MERCK
Reema Mehta
Head of Risk Assessment and Management
PFIZER
Vraj Patel
Medication Error Pharmacovigilance and Risk Management Fellow
REGENERON, FDA, BUTLER UNIVERSITY
Event Schedule
ALL TIMES ARE IN EASTERN STANDARD TIME
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
- Meet PMRs using REMS data
- Explore additional data to supplement REMS for Sponsor insights
- Discuss comparisons with European risk management
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
ALL TIMES ARE IN EASTERN STANDARD TIME
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
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