Under Pressure Appendix - Bio-Link

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1 Δεκ 2012 (πριν από 4 χρόνια και 8 μήνες)

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Appendix

“Under Pressure”

Regulatory Affairs

Regulatory Affairs (RA) is a dynamic and challenging profession that is vital to making
safe and effective healthcare products available worldwide. RA professionals are employed in
industry, government, and aca
demia. They work with a wide range of products, including
pharmaceuticals, medical devices, in vitro diagnostics, biologics and biotechnology products,
nutritional products, cosmetics, and veterinary products.

Products in these areas are subject to a vari
ety of legislative measures. Such legislation
mandates that a product meets safety requirements and establishes criteria for marketing
approvals. RA professionals reside in specialist departments within companies and provide
advice about legal and scient
ific restraints and requirements; collect, collate, and evaluate
scientific data; and present dossiers to regulatory agencies. RA professionals also carry out all
subsequent negotiations necessary to obtain and maintain marketing authorizations for the
pr
oducts in question.

RA professionals work in a complex constellation of relationships. The RA department
is often the first point of contact between government authorities and the company. As the
company’s representative to regulatory agencies, they must

strive to build strong working
relationships with those agencies in order to be effective. Failure to report all available data may
result in the need for a product recall. Such an occurrence may lead to the loss of several million
dollars in sales, not

to mention a reduction in customer and investor confidence.