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Ira R. Berry, Robert P. Martin
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The Pharmaceutical Regulatory Process, Second Edition - Summary
This comprehensive guide serves as an essential resource for understanding the complex landscape of pharmaceutical regulations and compliance requirements. The second edition provides updated insights into regulatory mechanisms, incorporating major legislative changes affecting drug safety reviews, product approvals, and marketing practices. Written collaboratively by industry experts, attorneys, and FDA regulators, it offers practical guidance for pharmaceutical companies to maintain regulatory compliance in the post-approval phase.
Key Ideas
Regulatory Compliance Framework
A detailed exploration of the evolving regulatory landscape, focusing on how pharmaceutical companies can establish and maintain compliance with current FDA requirements. This includes updated protocols for product approvals, safety reviews, and the implementation of post-market surveillance systems.
Safety and Quality Assurance
An in-depth examination of pharmacovigilance programs and quality standards, highlighting the importance of proactive safety monitoring and the prevention of widespread safety issues. The theme emphasizes the critical role of maintaining product quality throughout the supply chain.
Global Supply Chain Integrity
A comprehensive analysis of international pharmaceutical sourcing, addressing challenges related to foreign API procurement, counterfeit drug prevention, and maintaining quality standards across global supply networks. This theme explores the complexities of managing a worldwide pharmaceutical supply chain while ensuring regulatory compliance.
FAQ's
The second edition includes new chapters covering unapproved drug marketing, enhanced pharmacovigilance programs, foreign API sourcing, counterfeit drug issues, and updated quality standards, reflecting the latest regulatory changes and industry challenges.
The book provides practical solutions for maintaining regulatory compliance while addressing contemporary challenges such as global sourcing, counterfeit prevention, and implementation of advanced pharmacovigilance programs, all supported by expert insights from industry professionals and regulators.
This book is invaluable for pharmaceutical industry professionals, regulatory affairs specialists, quality assurance managers, and legal professionals working in pharmaceutical compliance, as well as students and academics studying pharmaceutical regulations and industry practices.
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