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Health committee  Mr. Chair, in response to the member's question and back to the point about who's responsible, the Public Health Agency does a surveillance. That surveillance is shared with Health Products and Food Branch, and the veterinary directorate considers that information and factors it

March 10th, 2011Committee meeting

Paul Glover

Public Accounts committee  If I may then, Mr. Chair, very quickly, as was pointed out on transparency, we're looking at what we can do to accelerate and go beyond the recommendations of the Auditor General. We're looking at issues like the labels and how readable they are, plain language information for

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  Mr. Chair, I thank the member for her question. It's true that our powers are somewhat limited with respect to our ability to request a change on… the monograph, the labels. We do have limited powers to demand or impose label updates on products as we see them. We end up workin

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  Thank you. Very briefly, the first is on the actual submission and approval of a product before it hits the market. We are in close collaboration with our international colleagues. There are some complexities with that where the drug companies don't always submit at the same tim

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  Thank you. Briefly, we will receive the report tomorrow. We have not yet received it. We will carefully consider that report, its recommendations, the feasibility of implementing those recommendations—

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  September is when we'll have a plan.

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  Just very briefly, Mr. Chair, in response to the member's question, I would be happy to provide the link to the various parts of our database. We have a newsletter that people can subscribe to for adverse events, so that they don't have to go searching. If they're worried about

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  I apologize; I don't have that number off the top of my head. But it is growing significantly each and every year.

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  It's been posted on our website, so it's available to all Canadians for them to query.

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  This is an aggregate report. This is the first in a series of steps we'll be taking to improve transparency in clinical trials. These are all trials: the types of issues we've seen, the types of trials being run, etc.

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  It does provide information on trial management, the types of issues—

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  —the types of problems, the documentation, things to look for, the most common adverse events we see, safety issues to look for. There is a wealth of information at an aggregate level—from our consultations, both participants and sponsors were looking for this—about trials, how

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  Mr. Chair, in response to the member's question, first and foremost, there is specific information on all of the drugs we've approved, and through MedEffect and CARN, any adverse events that are being reported to us. While we acknowledge that people take individual drugs, we pr

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  Thank you very much, Mr. Chair. I'd like to begin by just underlining that Health Canada was inspecting Sandoz. We did do an inspection. We found a number of areas. We made some observations in our report to them and we're following up with them. We made, as we do in any inspe

March 29th, 2012Committee meeting

Paul Glover

Public Accounts committee  Thank you very much, Mr. Chair, for the member's question. With respect to safety, first and foremost, the design of all clinical trials is subject to a review and approval by the department to ensure that the trial both achieves its objective in its design and that the patient'

March 29th, 2012Committee meeting

Paul Glover