enow.com Web Search

Search results

1. Results from the WOW.Com Content Network

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. 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 ...

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. Contract research organization - Wikipedia

   en.wikipedia.org/wiki/Contract_research_organization

   A CRO may provide such services as biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real world evidence. [1] CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets.

7. Fortrea - Wikipedia

   en.wikipedia.org/wiki/Fortrea

   Fortrea Holdings Inc. is a contract research organization organized in Delaware and headquartered in Durham, North Carolina with operations in 90 countries. Its customers are primarily in the pharmaceutical, biotechnology, and medical device industries.