Feature Article: Shared Risk: A Regulatory Management Strategy

By John Avellanet

Risk is inversely proportional to one's distance from a problem. For regulators, it seems straightforward to control biopharmaceutical and medical device risk. For pharmaceutical, biotechnology, and medical device executives, however, risk is hardly so clearly defined; it extends, grows, twists, and compounds through a chain of suppliers, consultants, and business partners. So when regulatory officials claim that compliance accountability cannot be delegated, biopharmaceutical and medical device companies are left holding the bag.

Years ago, as a C-level executive for a combination medical device company, I consistently wished for some way to entrust compliance accountability to those suppliers and outsourced vendors conducting the work, whether computer validation or contract manufacturing. Although blanket contract terminology ("company X will comply with regulations Y") can be inserted into any agreement, a supplier or vendor will not be the one in the news due to a regulatory investigation nor be the recipient of the government's notification of noncompliance.

Reprinted With Permission From BioProcess International

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