Phd Thesis On Drug Regulatory Affairs

We are responding to the needs of industries who are interested in recruiting and further training regulatory talent and from the professional organizations with a strong need for strategic and research training to support policy and business decision-making.

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Participants in this program take a set of interdependent courses that extend from a strong core of basic regulatory science coursework and additionally focus on three main areas—global product strategy, product lifecycle strategy, and project and personnel management.

The program is designed to meet the needs of individuals who are already working full-time outside of the university in positions in which they have substantial leadership or managerial responsibilities.

Most of the current leadership in Regulatory Science comes from individuals on the verge of retirement.

These individuals learned on-the-job slowly as the regulations developed and now are leaving the field; the next generation of leaders will not have the same luxury.

The products that they will foster, and the culturally and economically diverse countries in which they must operate, present a paradigm shift of a kind that this industry has not seen before.

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If we are to assure that new technologically sophisticated products make it to the marketplace, we must find new ways of benchmarking best practices and shortening the critical path that now exceeds a decade for most innovative pharmaceuticals and devices.

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A typical student in the program has somewhere between 10 and 15 years of experience in the regulated product industry with several years of experience managing or directing regulatory or quality departments.

The DRSc is classified as a professional doctoral degree. However similar to the Ph D, the DRSc includes a research-based dissertation and bestows the title of “Doctor” on its recipients.

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