Pages that link to "Glossary:TAG-00001-Med-rzn"

The following pages link to Glossary:TAG-00001-Med-rzn:

Displaying 50 items.

• Glossary (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product (← links)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1 (← links)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34 (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1 (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c) (← links)
• Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation (← links)
• Reference:USA 21 CFR Part 320 09-Apr-2025 § 320.22 (← links)
• Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 - (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 1 – 2 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3a–4 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85 (← links)
• Reference:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 Article 26 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (1) ; (6) (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6) (← links)
• Reference:DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 § 35a (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.3 (← links)
• Reference:FRA AEC DOC010 V.04 01-Jun-2018 - (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 18 (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 19 - 20 (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (d) (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001 (← links)
• Reference:USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009 III. A. (← links)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.7 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 96 Nr. 10, 11, 21 (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (g) (← links)
• Reference:GBR Medicines and Medical Devices Act 2021 21-Feb-2021 Chapter 2 Article 8 (← links)
• Reference:ICH ICH E21 Concept paper 2023 2. (← links)
• Reference:ICH ICH E11 Guideline R1 (2017) - (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41 (← links)
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j) (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event (← links)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction (← links)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (m) (← links)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.1. (← links)
• Reference:ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction (← links)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002 (← links)
• Reference:ICH ICH E2F Guideline 2010 1 (← links)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003 (← links)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53 (← links)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b) (← links)
• Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1 (← links)