Have the overall REMS adjustments prompted by the pandemic, as well as subsequent interactions with your stakeholders, aided in raising awareness of REMS goals? Who is responsible for guaranteeing patient safety and ensuring regulatory compliance? REMS compliance is contingent on your ability to coordinate multiple stakeholders, prepare for inspections, and effectively foresee and mitigate risk.
DGE’s 3rd REMS Summit (Sept. 12-13, 2022) provides unprecedented depth about inspection readiness, executing effective assessments, and juggling FDA submissions and changes, thanks to an all-new agenda created precisely around the questions most urgently needed by your peers. You can’t afford to miss these never before-heard insights from executives from Pfizer, Janssen, BMS, AstraZeneca, Merck, Walgreens, Alexion, and many more!
Agenda at a Glance
- Discover how sponsors running RFP processes consider the balance and tradeoffs between vendor/partner quality/qualifications versus cost
- Explore validated electronic software vehicles typically being used for exchanging REMS information across stakeholders
- Recognize the importance of KPIs and KQIs in proving the quality of REMS services and the influence these measures have on the relationship between sponsors and vendors
- Detailed case studies on recognizing and overcoming REMS implementation obstacles
- Ensure that AI's role in data interpretation clarifies stakeholder awareness and comprehension of crucial risk messages.
Who Should Attend
This conference is designed for pharmaceutical, biotech, and medical device professionals responsible for:
- Drug / Product Safety
- Clinical Risk Management
- Quality Assurance
- Risk Management
- REMS service providers
- Clinical Data Management
- Clinical Operations
- Clinical Affairs
- Regulatory Affairs / Compliance
- Medical Direction
- Life Cycle Management
- Epidemiology / Pharmacoepidemiology
- Health Scientist
- Medical affairs
- Quality management and Compliance
- Software Development and Technology
- Regulatory affairs
- Medical Affairs Operations & Risk Management
- Program Management
- Medical Director
- Project Manager
- Global Safety
- Patient Access
- Market Access
This Program Is Also Of Interest To:
- Technology vendors
- Data management services
- Pharmacovigilance / drug surveillance specialists
- Drug safety service providers
Top Reasons to Attend
- Hear directly from the FDA experts!
- Learn about regulatory requirements that can help you assure the accuracy of your evidence-based evaluations by attending
- Hear from industry leaders who have gone through the REMS program's implementation hurdles in the present US healthcare system.
- Get your questions answered directly from specialists and prepare for your highly regulated REMS inspection
- Gain valuable insights to avoid red flags and penalties with effective organization techniques
- All-new agenda built on feedback and requests from REMS leaders just like you!