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Search for "regulation"

Displaying results 1 to 4 out of 4

  Data Protection 81%
  ... or modification of the legal relationship (inventory data). The legal basis for this is article 6(1) b) f) EU General Data Protection Regulation (GDPR) and section 40(1) Medicinal Products Act (AMG). CRS customer data (company name, contact person, contact data, contact content) is ... will be stored for as long as the company exists. Clinical trial agreements are kept for a period of at least 25 years in accordance with EU
  Size: 32 K - Created: 27-06-17 - Modified: 26-09-17 10:39
Path: /Contact/Data Protection

  Medical Writing 79%
  ... data. They are able to integrate clinical and operational data into concisely written, well structured documents complying with current regulations and guidelines. The bottom line is that CRS makes sponsors' clinical trial documentation more efficient, saving both time and money. CRS’s ...
  Size: 32 K - Created: 18-11-12 - Modified: 20-06-17 17:09
Path: /Services/Medical Writing

  CTSM & GMP 75%
  ... EudraLex - Volume 4 GMP Bundesministerium der Justiz: Gesetze und Verordnungen  Homepage European Compliance Academy: Link to a list of GMP-Regulations Homepage European Commission: Directive 2001/20/EC, dated 17 JUL 2012  
  Size: 33 K - Created: 18-11-12 - Modified: 20-06-17 17:09
Path: /Services/CTSM & GMP

  2010-2017 58%
  ... doi: 10.1007/s00228-014-1767-x. Epub 2014 Oct 18. Regina Freunscht, MSc, Norbert Clemens, MD, PhD, CPI The New European Clinical Trial Regulation : Administrative and Operational Changes, DOI 10.14524/CR-14-0030 Hinrichs J, Schaumann F , Renne J, Schönfeld C, Faulenbach C, Winkler C, ... doi: 10.1007/s00228-014-1767-x. Epub 2014 Oct 18. Regina Freunscht, MSc, Norbert Clemens, MD, PhD, CPI The New European Clinical Trial
  Size: 65 K - Created: 09-11-15 - Modified: 27-07-17 10:05
Path: /Expertise/Published Expertise/2010-2017

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