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General European OMCL Network (GEON) QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (08) 87 R6 VALIDATION OF COMPUTERISED SYSTEMS ANNEX 1 VALIDATION OF EXCEL SPREADSHEETSFull document title and referenceValidation.

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The Commission of the European Union (EU) and the Council of Europe decided on 26 May 1994 to create a network of official medicines control laboratories (OMCLs). This network amounted to a new collaboration in the area of quality control of marketed medicinal products for human and veterinary use.

Under both the EMEA and the FDA, the drug development process includes preclinical testing; clinical trials with phase 1, 2, and 3 testing; and a final approval procedure. In the United States, an investigational new drug application is filed with the FDA for drugs that appear safe in the preclinical phase.

Official Medicines Control Laboratory (OMCL) is the term coined in Europe for a public institute in charge of controlling the quality of medicines and, depending on the country, other similar products (for example, medical devices). They are part of or report to national competent authorities (NCAs).

The Standard Terms database gives the equivalents of over 900 terms in 35 world languages: Albanian, Bosnian, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Irish, Italian, Kazakh, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, ...

The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe.

European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.

The EDQM protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. The standards set by the EDQM are recognised scientific benchmarks and are applied in Europe and beyond.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232