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Showing below up to 50 results in range #601 to #650.

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  1. Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54 (6 links)
  2. Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 (6 links)
  3. Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 68 (6 links)
  4. Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 77 (6 links)
  5. Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79 (6 links)
  6. Reference:DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und (6 links)
  7. Reference:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 § 35a (6 links)
  8. Reference:DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 § 32 (6 links)
  9. Reference:EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2 (6 links)
  10. Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1) (6 links)
  11. Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n (6 links)
  12. Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 - (6 links)
  13. Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Glossary (6 links)
  14. Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2 (6 links)
  15. Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2 (6 links)
  16. Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4 (6 links)
  17. Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1 (6 links)
  18. Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4 (6 links)
  19. Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001 (6 links)
  20. Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9 (6 links)
  21. Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 (6 links)
  22. Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8 (6 links)
  23. Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 (6 links)
  24. Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3 (6 links)
  25. Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.2 (6 links)
  26. Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3.5.3 (6 links)
  27. Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-001 (6 links)
  28. Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-002 (6 links)
  29. Reference:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 2.1 (6 links)
  30. Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 (6 links)
  31. Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3.1 (6 links)
  32. Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.5 (6 links)
  33. Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4 (6 links)
  34. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7 (6 links)
  35. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001 (6 links)
  36. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002 (6 links)
  37. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12 (6 links)
  38. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 64 – 66 (6 links)
  39. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 (6 links)
  40. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 52 (6 links)
  41. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5 (6 links)
  42. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66 (6 links)
  43. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68 (6 links)
  44. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 1 (6 links)
  45. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5 (6 links)
  46. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75 (6 links)
  47. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 (6 links)
  48. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 Paragraph 3 (6 links)
  49. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7 (6 links)
  50. Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3 (6 links)

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