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2. List of Guidances for Statistics in Regulatory Affairs

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

   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 and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...

3. Common Technical Document - Wikipedia

   en.wikipedia.org/wiki/Common_Technical_Document

   The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis

4. Electronic common technical document - Wikipedia

   en.wikipedia.org/wiki/Electronic_Common...

   The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...

5. European Medicines Agency - Wikipedia

   en.wikipedia.org/wiki/European_Medicines_Agency

   The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).

6. Marketing authorisation - Wikipedia

   en.wikipedia.org/wiki/Marketing_authorisation

   Depending on jurisdiction, the resulting document may be more detailed (in addition to data identifying the product and its marketing authorisation holder), for example containing addresses of all manufacturing sites, appended labelling, artwork of packaging components, etc. or may be simplified to a one-page document called certificate of ...

7. Good documentation practice - Wikipedia

   en.wikipedia.org/wiki/Good_documentation_practice

   Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)

8. Inflation and retail sales data greet a roaring stock market ...

   www.aol.com/finance/inflation-retail-sales-data...

   Retail reading. The final monthly retail sales report before the start of the holiday shopping season is set for release on Thursday. Economists estimate retail sales increased 0.3% over the prior ...

9. Trial master file - Wikipedia

   en.wikipedia.org/wiki/Trial_master_file

   The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...