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You have probably heard the buzz around Adverse Event Reporting (AER)
growing from a whisper to a dull roar at this point in the halls of
your company. From what we have seen, through many in-depth meetings
with our clients on this issue, it is being considered with the utmost
care and seriousness.
We believe AER is one of the most important issues that pharmaceutical
marketing research has faced in decades. If not handled with great care,
it could seriously impact the very foundation of our work. Pharmaceutical
manufacturers have committed to enhancing their own systems for AER,
and so in turn, the GfK U.S. Healthcare Companies are committed to assisting
our pharmaceutical client partners in meeting their legal and ethical
obligations. We are resolved to do what is necessary to support this
initiative, including working with our clients’ own policies and procedures
as well as developing our own internal policy and training program to
ensure that a thorough and consistent foundation of education is in
place with our 275 employees.
We made this same statement of support to clients in a letter distributed
in August and were gratified by the positive reaction it drew from a
number of clients who subsequently invited us to have in-depth conversations
with them (and often their own internal AER working groups) on this
issue. There is much learning to be shared on this complex topic, which
continues to evolve on an almost daily basis. As we are aware that many
of you are as eager for information on this significant issue as we
are, we would like to share with you our general observations to-date
through a document which also concludes with our own policy on AER.
As the issues that surround AER begin to gel and reach further clarity,
we will share up-to-the-minute updates with you each month through this
newsletter.
To download the October 2006 discussion on Adverse Event reporting,
including the GfK U.S. Healthcare Companies' policy, click the link
on the graphic image above.
Please be mindful of two caveats as you read this document and in particular,
the GfK U.S. Healthcare Companies’ policy. First, as stated in
the policy preamble, it is essential to note that we don’t
expect the GfK U.S. Healthcare Companies’ policy will supplant
our clients’ own company policies but rather the intention
is to establish a basis from which we can enter into a meaningful discussion
with clients on their own procedures. Second, the policy sets forth
an internal training program which will ensure a thorough and consistent
foundation of education on the issue of AER for our own 275-person employee
base. It is important to once again note here that we don’t
expect our training to supplant our clients’ own company training
procedures. This internal training will be completed with GfK
U.S. Healthcare Companies staff by mid-November.
We would be pleased to share our internal training materials with your
company and in fact, we have made the same offer to agencies and industry
organizations alike as we seek no competitive advantage in this area.
Rather, we simply feel that as the pharmaceutical industry’s leading
marketing research firm, we should in good faith share the knowledge
we have gained in this important undertaking as our competitors may
not have the same resources to dedicate to such thorough efforts.
Alternately,
the monthly AER updates that we intend to publish in this newsletter
as mentioned above, can also be distributed to you in hardcopy format
via a complimentary “subscription-based” resource we are publishing
for our clients called The Orange Pages. The Orange Pages is
intended to serve as a living, breathing resource of “Information, Education
and Issues Exploration for Today’s Pharmaceutical Marketing Researcher”
that we hope will be read with interest and kept within reach for ongoing
reference. The format is a handy sized three-ring binder designed to
hold “packets” of content that we will develop and distribute to our
clients on a variety of topics. 
Content packets, which will vary in length from several pages to several
chapters depending on the topic, will be delivered to client subscribers
on a monthly basis.
The Orange Pages materials will come to you
in an easy to identify (and appropriately-colored) orange envelope.
The materials will be three-hole punched for convenient "one-click"
assembly into your binder.
The plan for the next six to nine months is to focus the content of
The Orange Pages on AER and the increasingly complex regulatory
environment and discuss the ways in which the conduct of marketing research
may be impacted. Subsequent volumes of The Orange Pages will
no doubt change in theme and focus as we concentrate on addressing whatever
is the “hot topic” of the time.
If you would like to receive your own complimentary copy of The Orange Pages, and get on our distribution list for monthly addendums, please fill out the form below.
We look forward to continuing conversations with those of you who have
already made outreach to us on the issue of Adverse Events Reporting,
and we encourage any and all other clients who would like to discuss
this issue on a formal or informal basis to contact us.
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