Pages that link to "Glossary:TAG-00176-Ris-erh"

The following pages link to Glossary:TAG-00176-Ris-erh:

Displaying 25 items.

• Glossary (← links)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1 (← links)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 47 (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. (← links)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1 (← links)
• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9) (← links)
• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8) (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter I Section 1.8 (← links)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31a (← links)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 22 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-002 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m) (← links)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 17 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4 (← links)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.2.3 - 4.2.4 (← links)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2 (← links)
• Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.56 (← links)
• 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 (← links)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.10.1.6 (← links)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (7)-002 (← links)
• Reference:EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 - (← links)