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Glossary:TAG-00026-Min-isc

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Glossary > Minor / Paediatric

Minor / Paediatric
Tag-ID TAG-00026-Min-isc
English Minor / Paediatric subject / Child
French Mineur / Mineure / Sujet pédiatrique / Enfant
German Minderjähriger / Minderjährige / Minderjährige Person / Pädiatrischer Prüfungsteilnehmer / Pädiatrische Prüfungsteilnehmerin

References

 ScopeDocument partLanguageDocument
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 1HM§ 40b Absatz 1DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 3HM§ 40b Absatz 3DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 4 – 6MD§ 28 Absatz 4 – 6DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65MDArticle 65ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 10GArticle 10ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1HMArticle 32 Paragraph 1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 2-3HMArticle 32 Paragraph 2-3ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 4HMSchedule 1 Part 4ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E11 Guideline R1 (2017) -G-ENICH ICH E11 Guideline R1 (2017)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 1.2.7GIII. Annex 1 1.2.7ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12GIII. Annex 1 2.8.12ENICH ICH E6 Guideline R3 (2025)
USA 21 CFR Part 50 09-Apr-2025 Subpart DGSubpart DENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (n)G§ 50.3 (n)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (o)G§ 50.3 (o)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (p)G§ 50.3 (p)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (q)G§ 50.3 (q)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (r)G§ 50.3 (r)ENUSA 21 CFR Part 50 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 Subpart DGSubpart DENUSA 45 CFR Part 46 09-Apr-2025
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 V.GV.ENUSA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023