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Case Study Hosted by Real Life Sciences: Roadmap to Success – Navigating a PRCI Regulatory Submission with ‘Quantitative Communication’
Session Chair(s)
Stephen Doogan
Chief Product Officer
Real Life Sciences, Inc., United States
Ahmed Eldfrawy
Real Life Sciences, United States
Guidance on today’s key challenges, solutions, and communication strategies to successfully navigate your Health Canada PRCI submissions. Effectively manage the regulatory evolution from Qualitative to Quantitative disclosure methodologies. RSVP Required
Featured Topics:
- Illustrative Submission Timeline: Key Challenges
- Illustrative Submission Timeline: Key Optimizations
- Potential Road Bumps with Regulatory Submissions
- Optimizing around the Process Initiation Meetings (PIM)
- Enabling ‘Quantitative Communication’ with Regulators
- Common Pressure Points with SAEs in Submission Processes
- Anonymization Options
- Proactive Communication Strategy
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