Scientific Advisory Committee on Nonprescription Drugs - Agenda

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Place: Holland Cross, Tower B, Room 2048
Date and Time: November 16, 2012 / 8:30am to 3:30pm

Participants: SAC-NPD members, Health Canada
Chairperson: Larry Lynd
Science Advisor: Thea Mueller
Scientific and Regulatory Officers: Erica Harnett, Caroline Hunt

Closed Sessions:

8:30am - 9:00am

Refreshments

9:00am - 9:05am

Opening Remarks (Barbara Sabourin, Director General, Therapeutic Products Directorate)

9:05am - 9:20am

Review of the Agenda, Declaration of Affiliations and Interests (Chair)

9:20am - 9:25am

Review of how the recommendations from the previous meeting were used by Health Canada (Nonprescription Drug Evaluation Division)

Open Sessions: Morning - Draft Guidance on Switch Submissions

9:25am - 9:40am

Introduction of the issues - Draft Guidance on Switch Submissions including data requirements and labeling requirements (Thea Mueller, Bureau of Policy, Science and International Programs)

9:40am – 9:50am

Switch Submissions - Presentation (Consumer Health Products Canada)

9:50am - 10:15am

Questions and Answers

10:15am - 10:30am

Break

10:30am - 11:25am

Discussions

11:25am - 11:30am

Observers leave the meeting

Closed Sessions: Morning - Draft Guidance on Switch Submissions

11:30am - 12:15pm

Deliberation of Questions to the Committee regarding the Draft Guidance on Switch Submissions (members)

12:15pm - 1:00pm

Lunch

Closed Sessions: Afternoon - Product line extensions

1:00pm - 1:20pm

Presentation: Background information on Health Canada’s draft revised Guidance for Industry on the assessment of health product names for look-alike-sound-alike (LASA) attributes (Margaret Zimmermann, Marketed Health Products Directorate)

1:20pm - 3:20pm

Deliberation of Questions to the Committee regarding the revised guidance (members)

3:20pm - 3:30pm

Next steps (including date for the next meeting), Closing Remarks and Adjournment of Meeting (Chair)

Please note:

Portions of the above meeting will be open to observers.  If you wish to observe these portions, please contact Erica Harnett no later than October 12, 2012 for additional information.

Erica Harnett
Scientific and Regulatory Officer
Office of Business Transformation
erica.harnett@hc-sc.gc.ca
613-946-0458