Eudralex Volume 10 Technical Guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
Titel:
Eudralex Volume 10 Technical Guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
Herkunft/Verlag:
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Dokumentenart:
Technische Leitlinie
Inhalt:
Technical guidance on the format of the data fields of result-related information on clinical trials
GMP Seminare nach Thema
- Allgemeine QA Themen + GMP Compliance
- Regulatory Affairs
- Development
- Datenintegrität
- Analytik allgemein
- Good Distribution Practice
- Computervalidierung
- Validierung allgemein
- Pharma Engineering allgemein
- API/Wirkststoffe/Hilfsstoffe
- Medizinprodukte und Combination Products
- GMP Grundlagen / Basis-Seminare
- Verpackung und Packmittel
- Hygiene
- Biotechnologie/Blut/ATMP
- Sachkundige Person (QP)
- European Conferences and Education Courses
- Sonstiges
- GMP Audits
- Dokumentation
- Reinigungsvalidierung
- IT allgemein
- Verunreinigungen/Impurities
- OOS / OOT / OOE
- Rohstoff-Prüfung
- Methodenvalidierung
- Gerätequalifizierung
- Stabilitätsprüfung
- Allgemeine mikrobiologische Themen
- Mikrobiologische Tests
- Technik
- Herstellung allgemein
- Sterile Herstellung
- Feste/halbfeste Formen
- Phytopharmaka/Cannabis/Radiopharmazeutika