Scientific Advisory Committee for Bioavailability and Bioequivalence:
Announcement of meeting and invitation to participate in associated
workshop
This notice announces a forthcoming meeting of the Health Products and
Food Branch Scientific Advisory Committee on Bioavailability and Bioequivalence
(SAC-BB) and associated workshop. The workshop, which is to precede the
SAC-BB meeting, will be open to all stakeholders and participation is
hereby invited.
Mandate of the SAC-BB
To provide on-going and timely scientific, medical and clinical advice
on current and emerging issues related to the work of the Therapeutic
Products Directorate (TPD) pertaining to bioavailability and bioequivalence
of drugs.
For more details, please refer to the Terms of Reference of the SAC-BB
at:
http://www.hc-sc.gc.ca/hpfb-dgpsa/
tpd-dpt/index_activities_committees_e.html#3
Workshop format
The structure of the workshop on 3 June 2004 is intended to allow for
more direct stakeholder involvement in policy development and greater
transparency. All stakeholders are invited to attend this workshop. Only
two topics will be dealt with in order to give adequate time to fully
deliberate and finalize each issue. The working language of this meeting
will be English.
After brief inaugural presentations, the first topic to be discussed
(outliers and inadequate profiles) will be introduced. Selected invited
stakeholders will make a series of 10-minute presentations on the topic,
based on experience with these issues. A panel discussion (moderated by
the Chair of the SAC-BB) will ensue. The panel discussion will be restricted
to the SAC-BB members and invited presenters. These discussions will however
be open for all to hear/observe. This will be followed by open discussion,
permitting observers and members of the greater audience to provide input.
The same process will be repeated for the second topic (add-on studies
as described in Guideline A).
On 4 June 2004, the SAC-BB will deliberate on the issues in a closed
meeting before making their final recommendations to Health Canada (HC.)
Agenda
The detailed agenda for the workshop will be posted at a later date at:
http://www.hc-sc.gc.ca/hpfb-dgpsa/
tpd-dpt/index_activities_committees_e.html#3
In preparing presentations or comments, we ask that you consider fundamental
questions as outlined below.
Outliers/Inadequate Profiles
- What criteria should be used to define an adequately characterized
concentration-time profile? When can subjects with inadequate profiles
be removed from the statistical analyses of the study data without negating
the validity of the study?
- How should outliers be identified and how should data for these subjects
be analysed?
Add on Studies
- Should add-on studies continue to be permitted? If so, should more
stringent requirements apply?
Procedure
If you wish to attend the workshop, please inform the contact person
identified below, by 3 May 2004. There is no charge for registration.
However, the information is necessary for planning, as the number of registrants
will determine the venue for the meeting.
If you wish to make a presentation(s) please submit a brief abstract
(limit one page) of your proposed presentation along with a copy of your
curriculum vitae, including contact information, to the contact person
identified below by
10 May 2004. Unfortunately we can only accommodate
a limited number of presentations as indicated in the agenda. Presenters
will be selected based on the material submitted. We will endeavour to
ensure that all groups of stakeholders are represented.
It is expected that not all interested stakeholders will be able to attend
the meeting. If you are unable to attend the meeting and wish to comment
on the issues in writing, please do so by 17 May 2004. You may submit
comments by mail or e-mail to the contact person identified below.
Date and times
Workshop: 3 June 2004 (08:30 to 16:30)
SAC-BB deliberations: 4 June 2004 (08:30 to 16:00)
Deadline for registration for the meeting: 3 May 2004
Deadline for submission of abstracts to be considered for presentations:
10 May 2004
Deadline for submission of written comments: 17 May 2004
Deadline for submission of electronic presentations: 24 May 2004
Presentation times will be posted in the agenda at a later date.
Location
Ottawa. The precise venue for the meeting is to be confirmed based on
the number of registrants. Details of the venue will be announced on the
HC website as soon as they are confirmed.
Contact Person
Ms. Marilyn Davis
Therapeutic Products Directorate
Tower B, Holland Cross, A.L. 3102C3
1600 Scott St.
Ottawa, Ontario K1A 1B6
Telephone:(613) 957-6260
Facsimile: (613) 941-5035
e-mail: Marilyn_Davis@hc-sc.gc.ca
Please complete the following form (attach abstracts and CV if necessary)
and return by fax or email.
Scientific Advisory Committee for Bioavailability and Bioequivalence
*Exact location of workshop to be determined based on number of registrations.
Details will be posted on the Health Canada Website.
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