During this webinar, the featured speakers will review how The Food and Drug Administration (FDA) has evolved the implementation of risk evaluation and mitigation strategies (REMS) since its creation in the 2007 FDA Amendments Act.
Join the team of REMS experts to review some of the key moments, initiatives and lessons learned from 15 years of working in the REMS industry. Hear how guidance documents evolved to shape industry interactions and discover what’s likely to change next.
Learn how the approach to assessment report metrics, audits, technology, transactional forms and FDA operation insight demands have changed considerably and what this means to the target audience as they plan for their next REMS.
Join this webinar to gain insights into REMS and the latest FDA updates for professionals planning their next REMS.
Speakers
Carolyn Carr, Senior Director Global Risk Management & REMS Engagement Center, Syneos Health
Carolyn Carr has 16+ years of Engagement Center & REMS experience and is responsible for delivery of all REMS engagement center services. She has expertise in designing and managing complex projects, dedicated on delivering high quality, patient-focused solutions to ensure patient safety and awareness of risk, while supporting market access.
Message Presenter
Mary Orosco, Managing Director, Global Risk Management & REMS Account Management, Syneos Health
Mary Orosco has 9+ years of REMS experience and is a member of the Risk & Program Management team who support 15 REMS Programs for 80+ REMS Sponsors. She has expertise in REMS project and financial management, FDA negotiations and regulatory submissions.
Message Presenter
Paul Sheehan, Vice President Global Risk Management & REMS Strategy & Business Development, Syneos Health
Paul Sheehan has 20+ years of experience designing, implementing, and delivering global risk management programs. He participated in FDA REMS advisory panels, presented at international risk management conferences, and co-authored 17 books, journal articles, and scientific posters on pharmaceutical risk management activities.
Message Presenter
Justin Wilson, Executive Director Global Risk Management & REMS Technology, Syneos Health
Justin Wilson has 19+ years of Healthcare Technology experience, 10+ years of REMS experience, and launched 20+ REMS applications. He has expertise in building innovative technologies to drive operational excellence and increase speed, efficiency, and quality.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Risk management
- Drug safety
- Patient safety
- REMS operations
- Pharmacovigilance
- Regulatory affairs
- Epidemiology
- Pharmacoepidemiology
- Clinical development
- Program management
- Site management
- Clinical monitoring
- Remote monitoring
- Risk-based monitoring
- Virtual trials
- Decentralized trials
- Data management
- Late Phase
- Real-world evidence
- HEOR
- Patient recruitment
- Research and development
What You Will Learn
Attendees will gain insights into:
- How risk evaluation and mitigation strategies (REMS) have changed
- The directions of future REMS
- How this applies to your next REMS submission
Xtalks Partner
Syneos Health®
Syneos Health® (Nasdaq: SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs, and commercial capabilities to address modern market realities.
Together we share insights, use the latest technologies, and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.
To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com or subscribe to our podcast.
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