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EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been ...
In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No ...
The Qualified Person must declare whether a qualified person has verified the data disclosed, including sampling, analytical and test data underlying the information or opinions contained in the written disclosure; a description of how the data was verified and any limitations on the verification process; and an explanation of any failure to ...
Qualified immunity does not protect officials who violate "clearly established statutory or constitutional rights of which reasonable person would have known". [17] This is an objective standard , meaning that the standard does not depend on the subjective state of mind of the official but rather on whether a reasonable person would determine ...
Biden's comments came during a brief tour promoting the paperback release of his 2017 memoir, in which he details his eldest son's battle with brain cancer.
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Dog person. And, now, literally a dog person," part of the message reads. "The fear hits but I remember my neighbor, Dr. Gerry, a legendary veterinarian totally qualified to respond to any canine ...
Many people wonder whether they should be investing in qualified or non-qualified dividends and what the differences are. The largest difference is in how each is taxed. To help you determine what ...