Risk management is an ever-changing process and there is always room for reassessing and improving your REMS approach. In particular, better standardization is needed more urgently than ever. The need for better standardization is of urgent importance for REMS professionals. To address these and other ever-present questions, DGE invites you to attend its REMS Virtual Summit, streaming online April 8-9, 2021. During this intense skill-builder, all industry stakeholders will unite to enhance your understanding of REMS best practices, inclusion criteria, and submission methods. Through our proven interactive online platform, you’ll learn everything you need about assessing benefit-risk balance and evaluating the procedures for successful submissions.
- Deep dive into the full REMS life cycle
- Discover pitfalls of negotiating with the FDA
- Address challenges of working with the added time constraints needed for an ETASU
- Clear analysis for engaging external stakeholders
- Ensure proper management and coordination REMS submissions
- Minimize barriers for REMS standardization
This conference is designed for pharmaceutical, biotech, and medical device professionals responsible for:
- Clinical Risk Management
- Drug / Product Safety
- Quality Assurance
- Surveillance
- Pharmacovigilance
- Benefit / Risk Management
- REMS
- Clinical Data Management
- Clinical Operations
- Clinical Affairs
- Legal
- Regulatory Affairs / Compliance
- Medical Direction
- Life Cycle Management
- Epidemiology / Pharmacoepidemiology
This Program Is Also Of Interest To:
- Technology vendors
- Data management services
- Pharmacovigilance / drug surveillance specialists
- Drug safety service providers
- REMS service providers
- CROs
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