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  2. 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 ...

  3. 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.

  4. Qualified Person Responsible For Pharmacovigilance - Wikipedia

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

    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 ...

  5. Pharmacovigilance - Wikipedia

    en.wikipedia.org/wiki/Pharmacovigilance

    Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals (and in some countries consumers) to identify and report any adverse events to their national pharmacovigilance center, health authority (such as the European Medicines Agency or FDA), or to the drug manufacturer ...

  6. Contract research organization - Wikipedia

    en.wikipedia.org/wiki/Contract_research_organization

    The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...

  7. NYPD officer fractured Bronx man’s jaw over double ... - AOL

    www.aol.com/nypd-officer-fractured-bronx-man...

    A Bronx man alleged an NYPD officer beat him so badly during a wrongful arrest he required screws for his fractured jaw, according to a personal-injury complaint filed with the City Comptroller ...

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