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Hello All,
We have difficulties to obtain insurance policies that cover to the
volunteers whom participate in studies of bioavailability and
bioequivalence, of generic medicines.
Could anyone tell us your experiences in cost and restrictions by
policies
of this kind?
Thanks for your answers.
Piedad
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The following message was posted to: PharmPK
Why do you need an insurance policy to cover your subjects?
What you need is an insurance policy to cover you. This is from
experience.
Art Straughn, Pharm.D.
Professor Emeritus and Director Drug Research Laboratory
Department of Pharmaceutical Sciences
University of Tennessee
Memphis, TN
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The following message was posted to: PharmPK
Dear Piedad,
We obtain our cover for volunteers on a trial by trial basis from the
AON group who do have international connections. In South Africa, our
regulatory authority requires that all trail participants are cover
according to the recommendations of the Association of British
Pharmaceutical Industries (ABPI) which in essence is no-fault insurance.
It may be worth your while to contact AON who work in association with
other entities such as Gerling, Chubb etc. Some details which may
assist:
AON GBU (Global Business Unit) Pharmaceutical Industry Group
Bruce Eberly +1 415 486 7416, Donna Pfluger-Murray +1 212 441 2366 or
Beth Henry +1 215 255 1793
Hope this helps
Kind regards
Denise Richardt
Associate Director
Scientific & Regulatory Affairs
QdotPharma
South Africa
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The following message was posted to: PharmPK
Hello Art,
I believe that we are speaking about the same, but watched from another
point of view. The insurance anticipate the cost that would be for us to
cover in case of an unfortunate event for the volunteers. Then, of this
way we protect ourselves.
Piedad
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