Meetings with regulators are yours to direct. It’s up to you to get the most out of them. The ultimate purpose of these types of engagements it to help you make a decision and move your program forward. It’s important to be clear about the expected outcomes of the meeting, both internally and in your correspondence with your regulator.
Some concepts covered in this resource are:
- Level of engagement with Health Canada at various stages of development
- Examples of questions asked at the meeting
- Pre- and post-meeting processes
Although this resource addresses engagements with Health Canada, the key takeaways can also be helpful for your interactions with other global regulators.