دانلود کتاب امور نظارتی پزشکی: راهنمای تجهیزات پزشکی و مراقبت‌ سلامت Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products 4th Edition

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book.
Contents
۱: How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth in the Artificial Intelligence Era
۲: The Evolution of the Regulatory Professional: Perspectives on the Skill Sets and Capabilities That Will Define the Next Generation of Regulatory Professionals
۳: The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments
۴: Commercial Sense and What It Means for a Regulatory Manager or Executive
۵: Market Strategic Challenges for Medical Device (Asia/Pacific)
۶: A Regulatory Career in Asia
۷: Coaching and Leadership Skills for Regulatory Affairs
۸: Navigating Career Paths and Excelling in Regulatory Affairs
۹: Accelerating Access to in vitro Diagnostics: An Update
۱۰: Chemistry, Manufacturing, and Controls for Synthetic Oligonucleotide Therapeutics
۱۱: Labeling, Label, and Language: A Truly Global Matter
۱۲: Medical Device Clinical Trials in Asia Pacific: Regulatory Framework in the Asia Pacific Region
۱۳: ISO 13485: 2016—Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
۱۴: ISO 14971: Application of Risk Management to Medical Devices
۱۵: Medical Devices—IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance
۱۶: Good Submission Practice
۱۷: United States Medical Device Regulatory Framework
۱۸: Regulation of Combination Products in the United States
۱۹: European Union Medical Device Regulatory System
۲۰. Regulation of Combination Products in the European Union
۲۱: Saudi Arabia: Medical Device Regulation System
۲۲: Australian Medical Device Regulatory Framework: An Overview
۲۳: China: Medical Device Regulatory System
۲۴: Hong Kong: Medical Device Regulatory System
۲۵: India: Medical Device Regulatory System
۲۶: Indonesia: Medical Device Regulatory System
۲۷: Japan: Overview of Medical Device Regulation
۲۸: Korea: Medical Device Regulatory System
۲۹: Overview of Medical Device Regulation in Malaysia
۳۰: The Philippine Medical Device Regulatory System
۳۱: Singapore Medical Device Regulation
۳۲: Taiwan: Medical Device Regulatory System Introduction
۳۳: Thailand: Medical Device Control and Regulation
۳۴: Vietnam
۳۵: Leading the New Normal by Accelerating Digital Transformation
۳۶: Learning of Other Regulatory System for Medical Device Sector: Herbal Product Regulatory Classification in Asia and General Guidelines for Health Product Development
۳۷. Learning of Other Regulatory System for Medical Device Sector: Health Supplements—Singapore
۳۸: Learning of Other Regulatory System for Medical Device Sector: Global Health Supplement Regulations
۳۹: The Trend to Watch: Real-World Data and Real-World Evidence
۴۰: Prescription-to-OTC Switch: An Overview
۴۱: Emerging Evidence-Based Longevity Medicine and Products’ Regulatory Affairs
۴۲: Enterprise Risk Management: A Holistic Guide for Navigating Regulatory Affairs with ERM
۴۳: Technology and Digital Solutions
۴۴: Medtech Start-Up: Journey to First Product Approval
۴۵: Digital Transformation of Healthcare and Venture Capital’s Role in It
۴۶: A Former FDA Investigator’s Views on Compliance with the Medical Device Regulations
۴۷: Bridging the Gap: The Journey of Healthtech Startups from Laboratory to Market in Singapore and Beyond
۴۸: MedTech Start-Ups: A Possible Strategy for Fast Market Approval
۴۹: Role of Venture Capital in Healthcare Regulations
۵۰: Startup Regulatory at a Glance