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Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Case Study Hosted by Real Life Sciences: Roadmap to Success – Navigating a PRCI Regulatory Submission with ‘Quantitative Communication’

Session Chair(s)

Stephen  Doogan

Stephen Doogan

  • Chief Product Officer
  • Real Life Sciences, Inc., United States
Ahmed  Eldfrawy

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