April 8-9, 2021
Online Livestream
Summit
REMS VirtualSummit
Next-Gen Partnership & Technology Strategies to Advance Drug Safety Programs
Days
Hours
Minutes
Seconds

Risk management is an ever-changing process and there is always room for reassessing and improving your REMS approach. In particular, better standardization is needed more urgently than ever. The need for better standardization is of urgent importance for REMS professionals. To address these and other ever-present questions, DGE invites you to attend its REMS Virtual Summit, streaming online April 8-9, 2021. During this intense skill-builder, all industry stakeholders will unite to enhance your understanding of REMS best practices, inclusion criteria, and submission methods. Through our proven interactive online platform, you’ll learn everything you need about assessing benefit-risk balance and evaluating the procedures for successful submissions.

Top Reasons to Attend
  • Deep dive into the full REMS life cycle
  • Discover pitfalls of negotiating with the FDA
  • Address challenges of working with the added time constraints needed for an ETASU
  • Clear analysis for engaging external stakeholders
  • Ensure proper management and coordination REMS submissions
  • Minimize barriers for REMS standardization
Who Should Attend

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

  • Clinical Risk Management
  • Drug / Product Safety
  • Quality Assurance
  • Surveillance
  • Pharmacovigilance
  • Benefit / Risk Management
  • REMS
  • Clinical Data Management
  • Clinical Operations
  • Clinical Affairs
  • Legal
  • Regulatory Affairs / Compliance
  • Medical Direction
  • Life Cycle Management
  • Epidemiology / Pharmacoepidemiology

This Program Is Also Of Interest To:

  • Technology vendors
  • Data management services
  • Pharmacovigilance / drug surveillance specialists
  • Drug safety service providers
  • REMS service providers
  • CROs
Conference
New Topics
Featured Speakers
Bob Anders
AKEBIA THERAPEUTICS
Senior Scientific Director, Clinical Development
Carmit Strauss
AMGEN
Director, Global Safety (Benefit Risk Management Officer)
Deborah Collyar
PAIR: PATIENT ADVOCATES IN RESEARCH
Founder and President
Dr. Jaylaxmi Nalawade
LUPIN PHARMACEUTICALS
Associate Director, Pharmacovigilance and REMS
Eleni Samaras Allen
GLAXOSMITHKLINE
Scientific Director, REMS Lead
Feisal Othman
BRISTOL MYERS SQUIBB
Associate Director, Global Risk Management
Gita Toyserkani
FDA
Associate Director, Research and Strategic Initiatives - Division of Risk Management
Jacqueline Gerena, MBA
Aimmune Therapeutics
Director, Program Management
Jamie Wilkins
PFIZER
Director in the Center of Excellence for Risk Management, Worldwide Safety
John Klimek
John Klimek
NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS (NCPDP)
Sr VP Standards and Information Technology
Justin Wilson
UBC
Director, Software Development and Technology
Kal Elhoregy
AMNEAL PHARMACEUTICALS
Director, Risk Evaluation and Mitigation Strategy (REMS) Programs
Kevin Holman
JANSSEN
Director, REMS and Risk Management Center of Excellence
Khaudeja Bano
AMGEN
Executive Medical Director, Head of Combination Product Safety
Kishore Gopu
TEVA
Director
Kyle Irwin
JANSSEN
Operations Lead REMS
Laura Zendel
FDA
Team Leader
Liza Rodriguez
JANSSEN
Associate Director, REMS and Risk Management Center of Excellence
Michele Cioro
BRISTOL MYERS SQUIBB
Senior. Manager, REMS Customer Care
Michele Davidson
WALGREENS
Senior Manager, Pharmacy Technical Standards Development & Policy, Government Relations
Oyinkansola Odebo
SUPERNUS PHARMACEUTICAL
Assistant Director, Drug Safety
Patti Rossman
GLOBIOX
President
Pritam Dodeja
BRISTOL MYERS SQUIBB
Director, IT Business Partner
Reema Mehta
PFIZER
Head of Risk Management and Safety Surveillance Research
Suzanne Mcleod
HIKMA PHARMACEUTICALS
Manager, REMS and Drug Safety
Toyin Adewole
SUPERNUS PHARMACEUTICALS
Associate Director, Drug Safety
Event Schedule
All Times are in Eastern Standard Time                    

REMS managers face constant but predictable challenges, and must always be prepared to hurdle them.  This session works through an overview and effective strategies for different REMS Elements to Assure Safe Use (ETASU).

  • Evaluate the essentials of a REMS program
  • Set manageable goals to hit timeline markers and budgets
  • Tackle the continuous issues head-on=
Despite ongoing standardization, many REMS continue to utilize unique or non-standard
elements or processes. Explore past experience and case studies when it comes to
negotiating with the FDA.
 
  • Discuss common challenges during the NDA
  • Tackle issues faced from various NDAs
  • Address key areas for alignment during REMS negotiations with FDA

Sudden and unpredictable challenges can occur at any turn.  You will be best-suited for your own REMS program by learning from others who confronted the toughest issues and overcame them. 

  • Navigate issues that can go awry at any time during the REMS life cycle
  • Discuss case studies from those in the thick of the REMS system
  • Hear issues that you can come across that aren’t in the guidelines
Apply a logic model to the design and evaluation of REMS programs can enable a systematic approach to linking REMS objectives and interventions to the outputs and outcomes.
 
  • Link REMS input (design) and outputs (evaluation)
  • Complete a situational analysis taking into consideration the system, prescriber and
    patient level characteristics and preferences.
  • Ensure input from healthcare providers and patients during the risk management
    life-cycle
  • Determine and set primary and secondary endpoints for your REMS programs
Organizing and preparing throughout REMS development can help you ensure the
satisfactory documentation required. You and your teams will have to develop CAPAs that
implement best practice and address any areas of noncompliance.
 
  • Ensure your audit plan is comprehensive and actionable
  • Explore challenges and solutions related to program noncompliance
  • Build effective communication techniques with the FDA about noncompliance and
    CAPAs
  • Prepare for REMS audits which are highly regulated as well as those which are non
    regulated

Explore the value of incorporating novel technologies to REMS operations, delivering a more connected healthcare ecosystem.

  • Implement biometrics and QR code with ease
  • Understand the importance of Optical Character Recognition (OCR)
  • Discuss in-workflow direct connections in depth
FDA REMS guidelines and EMA GVP module XVI guidelines provide guidance in regards to
REMS programs and EU additional risk minimization measures development update and
evaluation
  • Explore shared requirements among regulators and guidance’s
  • Develop REMS program and REMS strategy with key global considerations in mind
Prepare for the approval and launch of an internally resourced ETASU REMS requires strategic planning, thoughtful REMS program operational development, and much collaboration. How is this approach affected when a REMS Sponsor could potentially have 2 products in the same class with the same identified risks launching in the same year?
 
  • Challenges and opportunities for REMS Program strategy
  • Utilize REMS operational efficiencies
  • Apply the learnings and innovation to REMS technology solutions to support a global multiproduct risk management platform
All Times are in Eastern Standard Time                    
FDA may require ETASU for a product associated with serious risks. What are the most
effective and reliable way for you to navigate these additional steps?
  • Address challenges of working with the added time constraints needed for an ETASU
  • Budget the additional ETASU costs to ensure manufacturers develop and operate
    these systems safely
  • Make sure the ETASU does not excessively burden patient access
Pharmacies are well positioned to ensure patient compliance with REMs programs. Pharmacy workflow is unique as they process claims in real-time using NCPDP standards. It is essential that REMs programs be incorporated into pharmacy workflow to mitigate burden and ensure compliance.
  • Understand pharmacy claims processing
  • Discuss opportunities to incorporate REMs programs into pharmacy workflow
  • Improve patient safety within REMs program

REMS programs are difficult enough in themselves – but implementing a shared system has another level of challenges teams must overcome.  

  • Delegate responsibilities and duties 
  • Hear how to apply, maintain and tackle issues that come with sharing a REMS database and infrastructure
  • Ensure proper timing of submissions
  • Coordinate editing efforts with your single REMS doc and materials 

REMS programs are complex endeavors, requiring input and participation from diverse teams within your company, external participants in the program, and often vendors. This session focuses on building streamlined and efficient methods for engagement among both cross-functional teams and external participants.

  • Build an effective internal coalition to build and manage REMS
  • Discuss best practices for engaging external stakeholders (i.e., patients, prescribers, pharmacies, and distributors)
  • Allocate stakeholder responsibility for requirements
  • Craft meaningful and effective communications to address risk

Engaging patients can influence research to be more patient centered, useful, and trustworthy and ultimately lead to greater use and uptake of research results by the patient and broader healthcare community

  • Tackle new standards of Real-Time Prescription Benefit
  • Hear the National Council for Prescription Drug Programs speak to the information needed to prescribers of REMS drugs
  • Address the Electronic Prior Authorization work side-by-side with REMS as many insurers/payers now require this

Engaging patients can influence research to be more patient centered, useful, and trustworthy and ultimately lead to greater use and uptake of research results by the patient and broader healthcare community

  • Optimize and conduct patient benefit–risk assessment 
  • Achieve rapid market penetration and product uptake
  • Review best practices for creating simple and detailed materials for REMS patients to easily read, understand and apply

Each product has a unique benefit/risk profile, and therefore will have individual risk management needs. How does Risk Management fit in at critical points in a development program, and ultimately influence determination of a final risk management approach prior to regulatory authority submission?

  • Discuss methodical approaches to risk management evaluation
  • Understand key timepoints in product development where risk management input and analysis is necessary
  • Explore best practices for development of a holistic risk management approach, including necessary contingencies
  • Discuss regulatory submission strategies and requirements

Patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation. As experts in living with a specific condition, the patient and their perspective are critical to REMS success.

  • Collect and utilize patient-focused approaches in drug development and regulatory decision-making
  • Understand how to capture the patient voice
  • Create an effective checklist with the patient in mind
  • Outline risk assessment and treatment benefits with the patient first mentality 
  • Communicate information that supports their decision-making
Register Now

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Days
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Workshops
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