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2. EudraLex - Wikipedia

   en.wikipedia.org/wiki/EudraLex

   EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 - Pharmaceutical Legislation. Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines.

3. Qualified person (European Union) - Wikipedia

   en.wikipedia.org/wiki/Qualified_person_(European...

   EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been ...

4. Validation (drug manufacture) - Wikipedia

   en.wikipedia.org/wiki/Validation_(drug_manufacture)

   Annex 11 states "Risk management should be applied throughout the lifecycle of the computerised system taking into account patient safety, data integrity and product quality. As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the ...

5. Directive 75/319/EEC - Wikipedia

   en.wikipedia.org/wiki/Directive_75/319/EEC

   Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products.

6. Today's Wordle Hint, Answer for #1275 on Sunday, December 15 ...

   www.aol.com/todays-wordle-hint-answer-1275...

   Today's Wordle Answer for #1275 on Sunday, December 15, 2024. Today's Wordle answer on Sunday, December 15, 2024, is FUNKY. How'd you do? Next: Catch up on other Wordle answers from this week.

7. European Medicines Agency - Wikipedia

   en.wikipedia.org/wiki/European_Medicines_Agency

   1.1.4 Herbal medicinal products. 1.1.5 Paediatry. 1.1.6 Advanced therapies. ... (EudraLex) Health-EU Portal official public health portal of the European Union

8. Why is the stock market down today? 'The market can't get a ...

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9. Thief returns stolen baby Jesus statue with note asking ...

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