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MONTREAL, May 3 -

OPEN TO: Analysts, investors and all interested parties

DATE: Tuesday, May 10, 2005

TIME: 1:30 P.ca or at
http://www.
The public, regulators , researchers, and policymakers have voiced
concerns about drug approval and post-marketing safety of pharmaceutical
products regulators and policymakers.

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"Everyone must realize that the identification of new safety information
after a drug's approval does not represent a failure of the approval process .

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CALL: 514-807-8791 (FOR ALL MONTREAL AND OVERSEAS PARTICIPANTS)
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Significantly , since most drug safety crises occur in the first few years
after approval.

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In August last year, at the annual meeting of
the International Society for Pharmacoepidemiology (ISPE), several of these
studies were presented."
The ISPE statement points out that the recognition of potential adverse
drug events by astute clinicians is a powerful and crucial means by which many
drug safety problems are initially identified. Faich insists.

Pharmacoepidemiology is the study of the use and effects of
pharmaceuticals in populations, and is the scientific discipline underlying
drug safety surveillance.

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22 - Since 2000, concerns have been
raised in many sectors about the possible relationship between anti-
inflammatory drugs (NSAIDs and COX2 selective inhibitors such as Vioxx and
Celebrex) and cardiac risk, and a number of studies have been conducted by
epidemiologists on this issue.

Here you will find a variety of sites that discuss these 'people called Methodist.

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Philanthropy Writers/Business Editors/Community Editors
ADVISORY.
Despite calls in countries such as Canada for the reporting of all
potential adverse drug events by manufacturers, healthcare professionals, and
consumers, the ISPE believes that this would be counter-productive, and would
overwhelm existing surveillance systems.
The ISPE statement asserts that applying established epidemiology methods
and techniques before and after a drug is approved and increasing the use of
post-marketing observational studies are imperative to improving patient
safety. The International Society for Pharmacoepidemiology
(ISPE) is a global organization of over 800 professionals interested in
pharmacoepidemiology, pharmaceutical safety surveillance, and therapeutic risk
management.

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Interested parties may also listen live at http://www.

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NOTE TO EDITORS: Multimedia Assets Available With This Story
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----Mother's Day is this Sunday .M.
According to ISPE President, Dr.

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until 11:59 P.com . Faich.

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International Society for Pharmacoepidemiology Raises Concerns About Limitations of Pre-Marketing Drug Trials -- Calls for Restrictions on Direct-to-Consumer A

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"To achieve this , the whole research community, in the US for example,
the NIH, Congress, AHRQ, FDA and others must recognize the importance of
increased funding for epidemiological evaluation of therapeutic compounds ,"
Dr.

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Multimedia Available: A Unique Way to Celebrate Mother's Day

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The ISPE Statement on Regulatory Systems to Improve Pharmaceutical Safety
was ratified by the Board of Directors and represents the consensus views of
the society , and is intended to be broadly applicable across international
boundaries.

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The Society also believes that most national regulatory agencies do not
possess adequate authority to ensure that manufacturers conduct adequate
post-marketing safety studies, including even those promised as a condition of
drug approval, or to address potential safety issues that emerge
post-approval.
The Society was critical, too, of the lack of coordination, cooperation
and balanced resourcing between industry and regulatory bodies, and the
administrative separation between bodies monitoring post-marketing safety and
those conducting epidemiological studies.

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If you're looking
for something a little different to do with your mother this year, why
not help a family in need? Throughout the entire month of May, women
will be participating in Women Build, a program that engages women to
help build Habitat for Humanity Homes for families in need.com/home. on Tuesday, May 17th . In response, concerns ISPE has issued a
statement suggesting a number of changes to the current review system, which
could contribute to, increased patient safety and reduced adverse events and
deaths. Lastly, it is essential
to expand the use of epidemiologic methods, approaches and training if we are
to improve drug safety.

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Please dial in 15 minutes before the conference begins.M.

MEDIA WISHING TO QUOTE AN ANALYST SHOULD CONTACT THE ANALYST PERSONALLY
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M.

NOTE TO FIRST-TIME ANALYSTS: Please contact Maison Brison at 514-731-0000
prior to the day of the conference call.
The issue has come to a head with the withdrawal from the marketplace of
Vioxx by its manufacturer, the recent de-listing of the pain medication Bextra
by Kaiser Permanente in California, and ultimately with the reexamination of
an entire drug class by FDA and European authorities.
To be effective, regulatory agencies must have the authority to insist on
the rapid implementation of pharmacoepidemiological safety studies to
understand potential risks.

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Gerald Faich, "The solution to many of
the perceived crises related to drug safety can be found in increasing the
number of patients involved in clinical trials and the number of clinical
trials that are conducted before and after drugs are launched. As such, ISPE feels a responsibility to offer its views on
existing systems for assuring pharmaceutical safety to interested
policymakers, members of the public and others.

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Visit
http://www.

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If you have any questions about the story, or about Newstream . Also, we need
to understand the patterns of the disease being treated by a new therapeutic
compound , even before efficacy trials are performed.

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This tape recording will be available on
Tuesday, May 10th, 2005 as of 3:30 P. ISPE favors the cautious marketing promotion of products and
recommends restricted direct-to-consumer (DTC) advertising for therapeutic
products until safety in usage has been adequately demonstrated.

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If you are unable to call in at this time, you may access a tape
recording of the meeting by calling 1-877-289-8525 and entering the passcode
21123675(pound key) on your phone.
These can be expected when a drug is used in expanded 'real world'
populations , and it should be recognized that post-marketing studies of safety
and effectiveness are necessary because of the inherent and inescapable
limitations of the drug approval process", stated Dr.