enow.com Web Search

Search results

  1. Results from the WOW.Com Content Network
  2. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. [1]

  3. List of Guidances for Statistics in Regulatory Affairs

    en.wikipedia.org/wiki/List_of_Guidances_for...

    EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry ...

  4. EudraLex - Wikipedia

    en.wikipedia.org/wiki/EudraLex

    Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828 ...

  5. Clinical Trials Directive - Wikipedia

    en.wikipedia.org/wiki/Clinical_Trials_Directive

    The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at ...

  6. Electronic trial master file - Wikipedia

    en.wikipedia.org/wiki/Electronic_trial_master_file

    An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

  7. Trial master file - Wikipedia

    en.wikipedia.org/wiki/Trial_master_file

    The first version of the TMF Reference Model (TMF RM) [5] was released in June 2010 and was updated in February, 2011 (v1.1) based on feedback provided by Regulators, and again in December, 2011 (v1.2), based on feedback provided by users of the model as they used it within their respective organizations to structure their paper and electronic ...

  8. Pfizer (PFE) Alopecia Drug Filings Get Accepted by FDA, EMA - AOL

    www.aol.com/news/pfizer-pfe-alopecia-drug...

    Pfizer (PFE) Alopecia Drug Filings Get Accepted by FDA, EMA. ... Pfizer’s stock is down 19% this year so far compared with a decrease of 1.7% for the industry. ... Loss estimates for 2023 have ...

  9. Good clinical practice - Wikipedia

    en.wikipedia.org/wiki/Good_clinical_practice

    European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]