REMS compliance depends on your skill at coordinating diverse stakeholders, preparing for inspections, and successfully predicting and minimizing risk. Are your operational goals realistic for the needs of your REMS program? Do you have everything you need for communicating with HCPs, pharmacies, and patients?
Now featuring an all-new agenda built specifically around the questions most urgently requested by your peers, DGE’s 2nd REMS Virtual Summit (October 11-12, 2021) provides unprecedented depth about setting timetables, implementing effective assessments, and juggling FDA submissions and modifications. You cannot afford to miss these never-before-shared insights from industry leaders, representing Pfizer, Janssen, GSK, Merck, Walgreens, Alexion and many more!
- Strategies for building rapid response teams that handle FDA requests quickly and accurately
- Understand new insights for adapting to issues that arise outside the guidelines
- Detailed case studies about spotting and overcoming challenges to REMS implementation
- Methods for handling multiple submission and modification deadlines while reducing stakeholder burden
- All-new agenda built on feedback and requests from REMS leaders just like you!
This conference is designed for pharmaceutical, biotech, and medical device professionals responsible for:
- REMS
- Drug / Product Safety
- Clinical Risk Management
- Quality Assurance
- Surveillance
- Pharmacovigilance
- Risk Management
- REMS service providers
- Clinical Data Management
- Clinical Operations
- Clinical Affairs
- Legal
- Regulatory Affairs / Compliance
- Medical Direction
- Life Cycle Management
- Epidemiology / Pharmacoepidemiology
- Pharmacist
- Health Scientist
- Medical affairs
- Quality management and Compliance
- Legal
- IT
- Software Development and Technology
- Regulatory affairs
- Medical Affairs Operations & Risk Management
- Program Management
- Medical Director
- Project Manager
- Global Safety
- Compliance
- Patient Access
- Market Access
- Research
This Program Is Also Of Interest To:
- Technology vendors
- Data management services
- Pharmacovigilance / drug surveillance specialists
- Drug safety service providers
- CROs
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