Applying pharmaceutical lessons: learning lessons from the past.
Systematic evaluation of a project, product or other successes, and failures, is an important method for improving the performance of a company, as well as that of an individual. One should evaluate and determine if lessons learned can be applied to the systems and procedures being used in the company. Even if the company does not have to adjust its strategies, procedures, portfolio or systems as a result of lessons it has learned, there may be pointers to communicate to staff. It is easy for many aspects of a system to become outdated, particularly in an organization that is growing or changing rapidly. It is therefore generally appropriate to evaluate the company's regulatory compliance, toxicology compliance, clinical auditing practices and other appropriate systems on an annual or biannual basis. Most lessons of success or failure are specific to a single situation because of the combination of people, drug, competition, priorities and many other factors involved, and cannot be extrapolated to other situations. Some general lessons and principles are presented that will facilitate drug discovery, development and marketing.
Spilker
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Scientific and Regulatory Affairs of PhRMA, Washington, DC, USA.