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Welcome to the October 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 In this issue, the pharmaceutical industry comments on FDA's draft guidance for contract manufacturing and quality agreements. Plus the emerging-market wage gap narrows, and analysis of models for CMC outsourcing. And the latest developments from the pharmaceutical industry in sustainability and global health.

Contract Manufacturing
Pharma Industry Comments on FDA's Draft Guidance for Contract Manufacturing
Patricia Van Arnum, executive editor of Pharmaceutical Technology and Pharmaceutical Technology Europe and editor of Sourcing and Management
Pharmaceutical companies and industry organization comment on FDA's draft guidance on contract manufacturing and quality agreements.
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Global Feature
Emerging-Market Wage Gap Projected to Narrow
Patricia Van Arnum, executive editor of Pharmaceutical Technology and editor of Sourcing and Management
A recent analysis by PricewaterhouseCoopers projects that the wage gap between advanced economics and emerging economies, such as China and India, will shrink significantly by 2030.
>> Read More

Outsourcing
Outsourcing Partnerships for CMC Development
Jim Miller, president of PharmSource Information Services
Are strategic partnerships in clinical research a model for CMC services?
>> 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

Pharma Industry and WHO Chart Progress on UN Millennium Development Goals
Patricia Van Arnum, executive editor of Pharmaceutical Technology and editor of Sourcing and Management
The United Nations discusses the progress in achieving the UN Millennium Development Goals and sets a path for post 2015, and the pharmaceutical industry offers its input.
>> Read More

Industry Events

For the full listing of calendar events, see the Calendar of Events page

Pharmaceutical Technology Webcast
Keys to Regulatory Compliance in the Pharmaceutical Supply Chain
Live Webcast: Thursday Oct. 17th, 2:00 PM to 2:30 PM EST
Ensuring product quality is of paramount importance to pharmaceutical manufacturers. Proper management and control of the pharmaceutical ingredient supply chain to ensure regulatory compliance and security of supply is critical. This 30-minute webcast will provide practical insight and case-study analysis on how to achieve transparency from suppliers, optimize planning for materials and capacity, and ensure operational efficiency for proper stocking levels and inventory replenishment.
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.
Registration information

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.
Registration information

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.
Registration information