
Forward Planning Analysis, Innovation, Patient Centricity and FDA Compliance as a Strategic Framework To Execute Successful REMS Programs
August 2-3, 2022 | Alexandria, VA

Innovating in the REMS space is critical, not only talking about technology but also talking about the approach with the FDA, the processes and the way we communicate with all the stakeholders internal and external. 15 years have passed since REMS was first implemented. We will deep dive into what has happened in this time, how REMS has evolved, the progress we are seeing to inform how the industry can optimize REMS moving forward in all stages.
This event will focus on how to work with sponsors and attract new ones, analyzing the FDA new ideas in terms of patient wellness and participation. We will focus on adjustments needed to stay up to date with technology, artificial intelligence and new platforms, the focus on patient education and prioritization for REMS and RMPs
MEET OUR SPEAKERS
Top Reasons to Attend
- Evaluate the use of AI in REMS for the greater good of every stakeholder, from patients to the FDA involvement
- Optimize patient education, wellness and health literacy, the key elements to great and successful REMS programs
- Develop best practices on how to efficiently document Safety and Adverse Events on REMS while remaining FDA compliant
- Understand the impact and growth from telemedicine and how to accommodate in the REMS space
- Analyze assessment metrics and determine the processes of approval for REMS programs
- Review the evolution of REMS, success, pitfalls, room for improvement and the continued growth of the programs
WHO SHOULD ATTEND
This event is designed for pharmaceutical, biotech, and medical device professionals with responsibilities in the following areas:
- REMS
- Benefit/Risk Management
- Drug/Product Safety
- Pharmacovigilance/Surveillance
- Medical Direction
- Quality Assurance
- Clinical Risk Management
- Life Cycle Management
- Regulatory Affairs/Legal/Compliance
- Clinical Affairs
- Clinical Data Management
- Clinical Operations
- Clinical Risk Management Compliance
- Epidemiology/Pharmacoepidemiology
- Patient Centricity – Patient Wellness
Thank you to our Sponsor
Pricing
PHARMACEUTICAL / MEDICAL DEVICES / BIOTECHNOLOGY
Early Bird
Register by 06/03/2022Advance
Register by 06/17/2022Standard
Register by 08/01/2022On Site Rate
.SOLUTIONS PROVIDERS / VENDORS
Early Bird
Register by 06/03/2022Advance
Register by 06/17/2022Standard
Register by 08/01/2022On Site Rate
.Groups discounts are available, if you wish to know more about them, please contact Frank Fernandez at frank@momentumevents.com
Click here to view the cancellation/refund/transfer policy