Sourcing and Management by Pharmaceutical Technology
November 2013 Volume 9 Issue 11
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Welcome to the November 2013 issue of Pharmaceutical Technology Sourcing and Management, Pharmaceutical Technology’s and Pharmaceutical Technology Europe’s information resource on pharmaceutical ingredients, manufacturing, and the supply chain. In this issue, a global outlook for contract manufacturing and clinical research. Plus, a roundup of investment activity from fine-chemical producers, CDMOs, and CMOs. And the latest developments from the pharmaceutical industry in sustainability and global health.
Global Feature
A Strong Outlook for Global Pharma Outsourcing
Patricia Van Arnum, executive editor of Pharmaceutical Technology and Pharmaceutical Technology Europe and editor of Sourcing and Management
Overall growth in the market for pharmaceutical contract research and manufacturing is strong although growth in established markets erodes at the expense of emerging markets.
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Outsourcing
Fine-Chemical Companies, CDMOs and CMOs Expand
Patricia Van Arnum, executive editor of Pharmaceutical Technology and editor of Sourcing and Management
A roundup of expansion activity of manufacturing capacity and service offerings from fine-chemical producers, CDMOs, and CMOs.
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Outsourcing
The Expense of Vision in Outsourcing
Jim Miller, president of PharmSource Information Services
Practicality of implementation should be a part of vision in the bio/pharmaceutical industry.
>> Read More
Pharma Industry’s Global Health and Sustainability Forum
Pharma News in Global Health and Sustainability
A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations. >> Read More
Industry Events
For the full listing of calendar events, see the Calendar of Events page
Pharmaceutical Technology Webcast
Ensuring Preparedness for Regulatory Inspections
Live Webcast: Thursday, November 7, 1:00 PM to 2:00 PM Eastern US
Regulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, who must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP). Successful GCP/GMP inspections can be achieved only through well-controlled laboratory, manufacturing, and quality systems with efficient access to related documentation and information. Often, technical limitations in content-management systems result in unsuccessful inspections. This 60-minute webcast will examine the approaches taken by regulatory authorities in GCP/GMP inspections and how properly executed document-management systems and advances in electronic data-management system (EMD) technology can better prepare companies for successful GCP/GMP inspections.
Registration information
Pharmaceutical Technology Webcast
Ensuring Global Regulatory Compliance for Product Registrations: Strategies for Risk Reduction and Operational Efficiency
On-Demand Webcast
Learn from industry and regulatory experts on how to create a robust quality management system for complying with country-based and regional-based regulatory requirements for product registration, product changes, and labeling changes. Gain insight into how to use automation for effectively tracking product registration and related correspondence to ensure global regulatory compliance.
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Pharmaceutical Technology Webcast
Achieving Raw-Material Transparency in the Pharmaceutical/ Biopharmaceutical Supply Chain
On-Demand Webcast
As regulatory demand increases on biopharmaceutical manufacturers to ensure the quality of the raw materials used for the manufacture of drug substances and formulation of finished drug products, these same demands filter back to suppliers. This 60-minute webcast will examine industry practice and use of regulatory guidance (FDA, EU, and ICH) for developing operational control and quality processes for mitigating risk in the pharmaceutical/biopharmaceutical supply chain. Learn from industry experts how to resolve the challenges toward achieving supply-chain transparency and its management as an ongoing concern.
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Pharmaceutical Technology Webcast
Risk Mitigation in API Manufacturing in Emerging Markets
On-Demand Webcast
Emerging markets are a crucial part of pharmaceutical companies’ growth strategy. Pharmaceutical manufacturers must align their strategy with partners that can facilitate access to local markets, manage complex supply chains, meet global and national regulatory standards for quality, and secure production of APIs and intermediates for local as well as established markets in North America and Western Europe. This 60-minute webcast will provide insight and case-study analysis on the approaches taken by pharmaceutical companies to build their manufacturing networks in select emerging markets while mitigating risk in supplier selection and qualification to ensure reliable, consistent API supply.
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