 |
As we revisit the topic of Adverse Event Reporting (AER) in our second
published document exploring issues in this area, we share with you
a number of new happenings. These include looking at the dynamics
of the confusion that ensues when individual pharmaceutical companies
issue their own Standard Operating Procedures (SOPs), while, simultaneously,
industry organizations are busily investing substantial amounts of
time and effort into formulating their own “position statements” and
“guidelines” related to the role of marketing research in the reporting
of Adverse Events (AEs).
We caution against these organizations’ expectations that pharmaceutical
companies will use these guidelines as a basis for reconsidering or
revamping their own very carefully considered SOPs. However, if these
organizations can work in close cooperation to establish one coherent
set of guidelines, it may well be of value in assisting small and
medium size marketing research agencies in understanding and complying
with pharmaceutical client companies’ SOPs. So, we suggest efforts
should accordingly be focused here, rather than looking to shape client-side
policies and procedures. Finally, as part of a “reality check,” we
also share a number of interesting experiences that the GfK U.S. Healthcare
Companies have encountered with AEs over the last month alone, which
shed light on some important lessons to be learned by client and agency-side
marketing researchers alike.
To download the November 2006 discussion
on AER, click the link on the graphic image above.
To get a flavor for recent industry coverage on AER, we encourage
you to read the story published this month in Pharma Market Research
Report, which features the viewpoints of The Council of American
Survey Research Organizations (CASRO) as well as GfK U.S. Healthcare
Companies.
To download this article, click the link on the graphic image to the
left.
The monthly AER updates that we publish in this newsletter 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 on a variety of topics.
For the next several months, the topic is AER, but in 2007 we will
address whatever is the issue of the moment. Content packets will
come to you in an easy to identify (and appropriately colored) orange
envelope and be delivered on a monthly basis. The materials will be
three-hole punched for convenient one-click assembly into your binder.
If you would like to receive a complimentary copy of The Orange
Pages, and get on our distribution list for monthly addendums,
please fill out the form below.
|
|
