NOTICE
Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT)
Announcement of meeting and invitation for stakeholder participation

Date: 2006-12-06

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Contact
Policy
Bureau
Enquiries

Ottawa, Ontario
January 2007

This notice announces a forthcoming meeting of the Health Products and Food Branch Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT). The purpose of the meeting is to obtain stakeholder input on the development of a guidance document for generic inhaled corticosteroids (ICS) in the treatment of asthma. Stakeholders wishing to make presentations are asked to register, at no charge, by December 18^th 2006. Registration details are provided below.

Mandate of the SAC-RAT

To provide on-going and timely scientific, medical and clinical advice on the evaluation of safety, efficacy and effectiveness of drugs used for the treatment of respiratory diseases and allergic conditions.

For more details, please refer to the Terms of Reference of the SAC-RAT at:

http://hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/index-eng.php

Meeting format

The meeting on January 10^th 2007 will address issues surrounding the development of a guidance document for generic inhaled corticosteroids. The working language of this meeting will be English.

On the morning of Wednesday January 10^th 2007, stakeholders are invited to make a series of 15-minute presentations on bioequivalence requirements for generic inhaled corticosteroids. Stakeholders must register using the form below by December 18^th 2006, indicating their preference for either observer or presenter status. Stakeholders may also make written submissions, which would be discussed during the open portion of the meeting. Each presentation will be followed by a question period, providing clarification to committee members only.

Following stakeholder presentations, the remainder of the afternoon will be reserved for committee members to deliberate and address questions in a closed format before making final recommendations to Health Canada.

Please Note: There will be no extensions to the deadlines for submission of presentations and time allowed per presentation will not exceed 15 minutes.

Agenda Items

The development of guidelines for generic inhaled corticosteroids will be discussed.

A Draft Agenda for the meeting and a Discussion Paper outlining proposed interim requirements may be found at:

http://hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/index-eng.php

Registration Procedure

Please register for the meeting by December 18^th 2006 using the registration form below, marking clearly if you are seeking presenter status at the meeting. There is no charge for registration.

If you wish to make a presentation, please submit, by December 18^th 2006, a brief abstract (limit one page) of your proposed presentation along with a copy of your curriculum vitae, including your contact information to the contact person identified below.

All final presentations must be submitted by close of business January 5^th 2007 or the presenter will be removed from the agenda.

It is anticipated that not all stakeholders will be able to attend the meeting. If you are unable to attend the meeting and wish to prepare a written submission, please do so by January 5^th 2007 . You may submit comments by mail or e-mail to the contact person identified below.

Date and deadlines

Monday December 18^th 2006

• Registration for all Attendees
• Request to Present and Submission of Abstract

Friday January 5^th 2007

• Submission of Final Presentations
• Written Submissions from stakeholders not attending

Wednesday January 10^th 2007
(10:00 am - 12:40 pm)

• Stakeholder Presentations; Questions and Answers

Updates to the agenda, presentation times and other details will be posted on Health Canada's website.

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/resp_allerg/index-eng.php

Location

The January 10^th 2007 meeting will take place in Boardroom 2048 of Tower B, Holland Cross at 1600 Scott Street in Ottawa, Ontario. Please note that lunch will not be provided. There is a food court on site where quick lunches may be purchased.

Contact Person

Ms. Jackie Hutchings,
SAC-RAT Coordinator
Therapeutic Products Directorate
Room 2091, Tower B, Holland Cross, A.L. 3102C3
1600 Scott Street
Ottawa , ON
K1A 0K9

Telephone: (613) 941-9290
Facsimile: (613) 941-5035
e-mail: Jackie_Hutchings@hc-sc.gc.ca

Please complete the following form (attach abstract and CV if necessary) and return by fax or e-mail by the dates outlined above.

Scientific Advisory Committee on Respiratory and Allergy Therapies

REGISTRATION FORM JANUARY 10th 2007, OTTAWA*
NAME	TITLE
ORGANIZATION
ADDRESS
CITY	PROVINCE	POSTAL CODE
PHONE	FAX	EMAIL
REGISTRATION REQUIREMENTS (PLEASE CHECK ONE)
WISH TO PRESENT ON GENERIC INHALED CORTICOSTEROIDS - ATTACH ABSTRACT & CV TO FORM
REQUEST OBSERVER STATUS ONLY
COMMENTS (ATTACH SHEETS IF NECESSARY)

* Exact order and time allotment of presentations will be determined based on number of registrations. Details will be posted on the Health Canada Website.