Webinar: Health Canada PRCI

Requirements, differences with EMA Policy 0070 and how to bring synergies between the two regulatory requirements

A Kinapse Webinar
Presented by Shalini Dwivedi & Pooja Phogat

Join Kinapse on September 4th for our webinar regarding Health Canada and the implementation of its Public Release of Clinical Information



On March 12th 2019, Health Canada (HC) published the final guidance on the process for implementing its Public Release of Clinical Information (PRCI) initiative pertaining to drug submissions and medical device applications. The guidance includes information and procedures for sponsors when preparing the relevant documents for public release, expectations for the protection of personal information (PI) and requirements for redaction of confidential business information (CBI). Kinapse has significant experience in preparing similar submissions under the equivalent European Medicines Agency (EMA) requirements (EMA Policy 0043 and Policy 0070) and have gained experience with the new HC PRCI initiative.

 

This webinar will be focused on HC PRCI requirements, differences with EMA Policy 0070, bringing synergies between the two regulatory requirements.

 

Who should attend: Anyone working in,

  • Clinical Research
  • Regulatory Affairs
  • Medical Writing
  • Trial Transparency
  • Clinical Trial Disclosures
  • Biostatistics

 

After the event, attendees will get to know:

  • What is HC PRCI initiative?
  • How to prepare for HC PRCI submissions?
  • What to expect at reviews?
  • Challenges and mitigation strategies?

To learn more about Health Canada and Kinapse's expertise in helping meet regulation, join us our webinar on the 4th of September.


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