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"Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation" was published by Taylor & Francis Group in 2021 - Milton, it has 1 pages and the language of the book is English.


“Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation” Metadata:

  • Title: ➤  Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation
  • Authors:
  • Language: English
  • Number of Pages: 1
  • Publisher: Taylor & Francis Group
  • Publish Date:
  • Publish Location: Milton

“Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation” Subjects and Themes:

Edition Specifications:

  • Pagination: 408

Edition Identifiers:

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"Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation" Description:

Open Data:

Cover -- Half Title -- Series Page -- Title Page -- Copyright Page -- Table of Contents -- Editors -- List of Contributors -- Introduction Chapter -- Part A: Regulatory Landscape and Interdisciplinary Collaboration in Safety Evaluation -- Chapter 1: The Emergence of Aggregate Safety Assessment across the Regulatory Landscape -- 1.1 Introduction -- 1.2 Food and Drug Administration (FDA) Regulations -- 1.3 EMA Regulations -- 1.4 Japan Pharmaceuticals and Medical Devices Agency (PMDA) Regulations -- 1.5 China National Medical Products Administration (NMPA) Regulations -- 1.6 Post-Marketing Aggregate Safety Analysis -- 1.7 Real-World Health Data -- 1.8 Discussion -- References -- Chapter 2: Monitoring of Aggregate Safety Data in Clinical Development: A Proactive Approach -- 2.1 Background: The Need for Pre-Marketing Safety Surveillance -- 2.2 The Aggregate Safety Assessment Plan (ASAP) -- 2.2.1 Section 1: Value Proposition and Governance -- 2.2.2 Section 2: Safety Topics of Interest and Pooling Strategy -- 2.2.3 Section 3: Data Analysis Approaches -- 2.2.4 Section 4: Analysis of Key Gaps -- 2.2.5 Section 5: Ongoing Aggregate Safety Evaluation (OASE) -- 2.2.5.1 Multiplicity in Safety Data -- 2.2.5.2 Some Methods for Monitoring and Signal Detection -- 2.2.6 Section 6: Communication of Safety Information -- 2.3 The ASAP as a Modular Template-Driven Approach -- 2.4 The ASAP as a Safety Planning Tool to Respond to a Pandemic Such as COVID-19 -- 2.4.1 General Effect on Data Collection -- 2.4.2 Unanticipated Infections of Subjects in the Clinical Trials Due to the Pandemic -- 2.4.3 Using the ASAP To Respond to a Pandemic: -- 2.5 Anticipated Hurdles toward Implementation of the ASAP -- 2.6 Foundation: Intelligent Data Architecture -- 2.6.1 Consistent Implementation of Derivation Rules -- 2.6.2 Consistent MedDRA Coding

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