As the select event for risk evaluation and mitigation strategy
professionals, this Summit convenes REMS
stakeholders to inform the design and redesign of REMS programs. Attendees acquire the tools and strategies to better integrate with healthcare systems by engaging with healthcare providers, pharmacists and patient advocates - key REMS
stakeholders - who illuminate the particular burdens that REMS imposes.
The 11th REMS Summit
continues to be the preeminent event for updates related to new regulations and emerging issues associated with REMS
, including standardization, evaluation, and structured product labeling. Learn from and interact with your peers, as well as crucial stakeholders and distinguished thought leaders who comprise this year's speaking faculty.
We welcome you to witness firsthand why +350 elite professionals have relied on our REMS
series for the last decade!
Top Reasons to Attend:
- Collaborate with industry leaders on innovative approaches for REMS design, implementations, solution updates and feedback from the FDA
- Comply with regulations pertaining to standardization and evaluations
- Assess REMS efficacy with proven and progressive methods
- Increase knowledge of upcoming REMS technologies, innovation, regulatory changes that will affect your work in risk management
- Discuss the hurdles of recent FDA guidance's impacting REMS
- Lessen the burden on stakeholders with a comprehensive understanding of their nuanced needs and stressors
Who Should Attend
This event is ideal for professionals from payers and pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas:
- Risk Management
- 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
This conference is also of interest to:
- Risk Safety and REMS Service Providers
- Data Management Service Providers
- Healthcare Information Marketing and Technology Providers
- Dashboard and Metrics Service Providers
- Law Firms
- May Chan-Liston, Director, CELGENE
- Deborah Collyar, President, PATIENT ADVOCATES IN RESEARCH
- Michele V. Davidson, Senior Manager, Pharmacy Technical Standards, Development and Policy, Government Relations, WALGREENS CO
- Sara Eggers, Operations Research Analyst, US FOOD & DRUG ADMINISTRATION - CDER
- Patrick Fleming, Clinical Pharmacist, THE UNIVERSITY OF ILLINOIS HOSPITAL AND HEALTH SCIENCES SYSTEM
- Emily Freeman, Ph.D., Director, HEOR- Patient Centered Outcomes, ABBVIE
- Erica Gooch, Clinical Safety and Risk Management Medical Associate, MERCK
- Kenneth Hornbuckle, Manager, Global Product Safety, ELI LILLY AND COMPANY
- John Klimek, R.Ph., SVP Standards and IT, NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS, INC.
- Brian Malkin, FDA Counsel, ARTENT FOX
- 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
- Rachel Sobel, Senior Director, Epidemiology Group Lead, GIP, PFIZER
- Deborah Tiffany, Director, Global Risk Mgmt Product Lead, Process Analyst, Worldwide Safety and Regulatory, PFIZER
- Kevin White, Director REMS Technology, CELGENE
- Michael Wolf, Ph.D., MPH, Professor, Medicine and Learning Sciences, Associate Chair, Department of Medicine, Associate Division Chief, Research, General Internal Medicine and Geriatrics, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY
VenueSheraton Pentagon City
900 S. Orme St.
Arlington, VA 22204
Discover something new at the recently renovated Sheraton Pentagon City Hotel. From new carpeting and totally updated guest rooms to an all-new lobby, we're evolving with your comfort in mind. Stay connected with our lobby's new ''connection destination,'' the Link@Sheraton experienced with Microsoft, which offers a secure and fun area to work or just hang out. Or, retreat to our chic and all-new guest rooms, newly outfitted with our signature Sheraton Sweet Sleeper Bed and flat-screen TV.
With the Reagan National Airport; Metro Rail Station; downtown Washington, DC; and the Pentagon all just minutes away, the heart of the nation is at your fingertips. Through arranging discounted overnight accommodations, transportation, receptions and other services, our trained team of professionals can help remove some of the stress surrounding the planning of a memorial at Arlington National Cemetery or any other event in the area.
To make reservations, please call 1-800-325-3535 and request the negotiated rate for ExL's January Meetings. To make reservations online Click Here
The group rate is available until January 7, 2018. Please book your room early, as rooms available at this rate are limited.