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Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms - Agenda
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(PDF Version - 34 K)Contact: Bureau of Policy, Science and International Programs Enquiries
Date: June 11th, 2010
Place: Hampton Inn Ottawa and Conference Centre
Date and Time: June 11th 2010 9:00am to 4:00pm, EST
Chairperson: Jake Thiessen
Science Advisor: Conrad Pereira
Science and Regulatory Officer: Marilyn Davis
Participants: SAP-MRDF members, Health Canada, Stakeholders
1.
09:00-09:05
(5 min)
Welcome and Opening remarks
Barbara Sabourin, Senior Executive Director, Therapeutic Products Directorate
2.
09:05-09:15
(10 min)
Introduction of Members, Chair’s address, Review of Agenda
Chair - Jake Thiessen
3.
09:15-09:25
(10 min)
Health Canada presentation
Office of Science / Questions from SAP-MRDF members
4.
09:25-10:05
(40 min)
Stakeholder Presentations
Company representatives / Questions from SAP-MRDF members (~ 10 min./each)
5.
10:05-10:20
(15 min)
Coffee break
6.
10:20-12:00
(100 min)
Stakeholder Presentations
Company representatives / Questions from SAP-MRDF members (~ 10 min./each)
Workshop concludes - all stakeholders are asked to leave
7.
12:00-01:00
(60 min)
Lunch
8.
01:00-01:15
(15 min)
Conflict of Interest Declarations
Chair
9.
01:15-02:30
(75 min)
Deliberations and Answer: Question 1
SAP-MRDF members
Question 1: Are current comparative bioavailability metrics and standards1 adequate for modified-release dosage forms?
10.
02:30-03:45
(75 min)
Deliberations and Answer: Question 2
SAP-MRDF members
Question 2: If current metrics and standards are considered inadequate, what metrics and standards would you recommend and under what circumstances would they be applied? Proposals should be supported by scientific rationales and data.
11.
03:45-03:55
(10 min)
Summary of Recommendations and Next steps
Chair
12.
03:55-04:00
(5 min)
Closing Remarks and Adjournment of Meeting
Chair
*Times indicated are to be used as a guide for the Chairperson and are approximate.
1See Therapeutic Products Directorate Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part B: Oral Modified Release Formulations (1996).
