Ensuring Regulatory Compliance in Pharmaceutical Supply Chains: Strategies for New Drug Introductions

EasyChair Preprint 13668

Abstract

Ensuring regulatory compliance in pharmaceutical supply chains is critical, especially when introducing new drugs to the market. This article delves into the complexities and strategies involved in maintaining compliance throughout the pharmaceutical supply chain. It covers the regulatory landscape, the drug introduction process, risk management, technology and automation, data integrity, staff training, third-party management, and future trends. Through detailed examination and case studies, this comprehensive guide aims to provide pharmaceutical companies with the knowledge and tools necessary to navigate the regulatory landscape effectively, ensuring the successful and compliant introduction of new drugs.

Keyphrases: Artificial Intelligence in Compliance, Automation in Manufacturing, Blockchain for Traceability, Compliance Training Programs, Data Integrity, Digital Transformation, Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), New Drug Introductions, Pharmacovigilance, Post-Approval Obligations, Quality Management Systems (QMS), Regulatory Compliance, Supplier Qualification, Supply Chain Security, Sustainable Practices in Pharmaceuticals, Technology in Pharmaceuticals, clinical trials, pharmaceutical supply chain, risk management

@booklet{EasyChair:13668,
  author    = {Olawale Ajala},
  title     = {Ensuring Regulatory Compliance in Pharmaceutical Supply Chains: Strategies for New Drug Introductions},
  howpublished = {EasyChair Preprint 13668},
  year      = {EasyChair, 2024}}