2022-11-02 For several years now, the U.S. Food and Drug Administration (FDA) and the life sciences industry have collaborated to develop guidelines for improving quality best practices in the validation of computer systems and to harmonize with international standards. The FDA’s...
2022-06-14 We see the medical affairs function suddenly elevated from its supporting role to a leading strategic partner, as it takes on the ownership of engagement across stakeholders.
2020-12-16 How will jurisdictions confidently and efficiently predict demand, order vaccines, and inoculate populations to meet their goals? Fortunately, there are proven practices, tools and technologies that can help organizations improve their effectiveness in these endeavors.