Expert Advisory Committee on
Bioavailability and Bioequivalence:
Announcement of meeting and invitation to
participate in associated workshop
Ottawa, Ontario
June 26, 2003
This notice announces a forthcoming meeting of the Health Canada (HC)
Expert Advisory Committee on Bioavailability and Bioequivalence (EAC-BB)
and associated workshop. The workshop, which is to precede the EAC-BB
meeting, will be open to all stakeholders and participation is hereby
invited.
MANDATE OF THE EAC-BB
To provide on-going and timely medical, scientific and clinical
advice on current and emerging issues related to HC's work pertaining
to bioavailability and bioequivalence of drugs.
For more details, please refer to the Terms of Reference
of the EAC-BB at:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/advcomm_eacbb.html
WORKSHOP FORMAT
The structure of the workshop on 26 June 2003 is intended
to allow for more direct stakeholder involvement and greater transparency
in policy development. All stakeholders are invited to attend this workshop.
Only two topics will be dealt with in order to give adequate time to fully
address and deliberate each issue. The working language of this meeting
will be English.
There will be an introductory presentation on the first
topic to be discussed (highly variable drugs). Selected
invited stakeholders will then make a series of 10-minute presentations
on the issue. A facilitated discussion open to all present will ensue
permitting observers and members of the audience to provide input. The
same process will be repeated for the second topic (requirements
for food effect studies).
On 27 June 2003, the EAC-BB will deliberate the issues in
camera before making their final recommendations to HC.
AGENDA
The detailed agenda for the workshop has not yet been finalized.
The brief summaries below outline the current status of the issues to
be discussed. Once completed, the agenda and all relevant discussion papers
will be posted on Health Canada’s web site (URL above.)
Highly variable drugs
Health Canada does not currently have any specific guidance
or make any specific allowances with respect to bioequivalence requirements
for highly variable drugs. It is expected that the study design, for example
the number of subjects, will take variability into consideration. It is
Health Canada’s intention to explore the need for special bioequivalence
requirements with respect to highly variable drugs. A discussion paper
on this issue is currently being developed and will be posted on this
website before the June meeting.
Requirements for food effect studies
This discussion is intended to examine the need for food-effect
comparative bioavailability studies in general (all submissions types),
with a view to developing a general guidance document on this issue. Currently,
comparative bioavailability studies under fed conditions are normally
required, in addition to studies under fasted conditions, for modified-release
products, highly toxic and narrow therapeutic range (critical dose) drugs
and drugs exhibiting non-linear pharmacokinetics. In some cases it may
also be possible to justify conducting a study under fed conditions in
lieu of a fasted study. A discussion paper on this issue is currently
being developed and will be posted on this website before the June meeting.
PROCEDURE
Based on feedback and comments received after our first
workshop in November 2002, there will be some changes to the procedure,
and DEADLINES WILL BE ENFORCED. If you wish to attend the workshop
as an observer, please inform the contact person identified below before
30 May 2003. There is no charge for registration, however the registration
form must be completed as the information is necessary for planning and
accommodation purposes. Registration is limited to 60 persons, and will
be accepted on a first-come, first served basis. However, in order to
allow the widest possible representation, registration may be limited
to one individual per organization.
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 30 May 2003. Unfortunately we can only
accommodate a limited number of presentations based on available time.
Presenters will be selected based on the material submitted. We will endeavour
to ensure that all groups of stakeholders are represented. If we do not
receive your abstract by the due date, you will not be allowed to present.
An electronic copy of your final presentation must be submitted to HC
before end of day, 20 June 2003. There will be NO EXCEPTIONS.
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 discussion papers in writing, please do so
by 20 June 2003. You may submit comments by mail or e-mail to the
contact person identified below. In preparing presentations or comments,
we ask that you consider the above summaries and the discussion papers
which will be posted on the HC web site.
Registration will be confirmed by email to as many applicants
as we can accommodate (limited by room size.)
DATE AND TIMES
Workshop: 26 June 2003 (08:30 to 16:30) (times approximate)
EAC-BB deliberations: 27 June 2003 (08:30 to 16:00) (times approximate)
Deadline for registration for the meeting: 30 May 2003
Deadline for submission of abstracts to be considered for presentations:
30 May 2003
Deadline for submission of written comments: 20 June 2003
Deadline for electronic copy of presentations to reach HC: 16:00 (Eastern
time) 20 June 2003
Please see the agenda to be posted on HC website for approximate presentation
times.
LOCATION
Lord Elgin Hotel, Pearson Room
100 Elgin Street
Ottawa, Ontario
K1P 5K8
Tel: 613-235-3333
Fax: 613–235-3223
http://www.lordelginhotel.ca/
Additional details 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. (Rm. 2089)
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.
Expert Advisory Committee for Bioavailability and Bioequivalence
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