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  2. Qualified Person Responsible For Pharmacovigilance - Wikipedia

    en.wikipedia.org/wiki/Qualified_Person...

    The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...

  3. MedDRA - Wikipedia

    en.wikipedia.org/wiki/MedDRA

    A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing ...

  4. Medicines and Healthcare products Regulatory Agency

    en.wikipedia.org/wiki/Medicines_and_Healthcare...

    The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.

  5. Pharmacovigilance - Wikipedia

    en.wikipedia.org/wiki/Pharmacovigilance

    Patient and healthcare provider reports (via pharmacovigilance agreements or national mandated reporting laws), as well as other sources such as cases reported in medical literature, play a critical role in providing the data necessary for pharmacovigilance to take place. In order to market or to test a pharmaceutical product in most countries ...

  6. Fortrea - Wikipedia

    en.wikipedia.org/wiki/Fortrea

    In 2000, the company opened a central laboratory in Singapore, building on clinical-development services formed in Singapore in 1996. [10] [11] In 2013, it expanded the capacity of the laboratory by 50%. [12] [13] [14] In March 2001, the company sold Covance Pharmaceutical Packaging Services to Fisher Scientific for $137.5 million. [15] [16] [17]

  7. Glenn Close Opens Up About Feeling Like a Hollywood 'Outsider'

    www.aol.com/glenn-close-opens-feeling-hollywood...

    Glenn Close has been a Hollywood mainstay for five decades. In addition to her roles in box office smashes for heavy hitters like Disney and Marvel, the three-time Golden Globe, Emmy, and Tony ...

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