Greetings!
Every new drug approval begins with understanding the regulatory pathway.
From drug development and pre-submission meetings to CTD preparation, filing and regulatory review, bringing a new drug to market involves a structured process with specific requirements at every stage.
This workshop provides a practical introduction to that process and the regulatory framework behind it.
Participants will explore:
- How the drug development and approval process works
- The fundamentals of New Drug Submissions (NDS)
- Notice types and Health Canada’s Priority Review Policy
- The role of pre-submission meetings
- Submission formatting, filing and screening
- The structure and purpose of the Common Technical Document (CTD)
- Key CTD modules and their role in a submission
- How eCTD can streamline the regulatory submission process
Designed for professionals entering Regulatory Affairs, as well as those in Quality, Drug Development and the pharmaceutical industry who want to strengthen their understanding of the submission and approval process.
Build the regulatory foundation behind successful drug submissions. *All participants will receive a Certificate of Attendance upon completion. |
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