Transportation and Storage of Temperature-Sensitive Pharmaceuticals in a Risk-Based Regulatory Environment: A 21st Century Initiative
June 13-14, 2007 | Bethesda, Maryland

Download brochure (229 KB) Global members of the pharmaceutical and bio-pharmaceutical industries continue to be faced with evolving regulations and pharmacopeial standards for handling, storing and distributing temperature-controlled products, including those that require controlled room temperature, refrigeration and freezing conditions. The 2007 PDA Pharmaceutical Cold Chain Management Conference will bring together industry and regulatory representatives to provide guidance on patient safety and product integrity as it relates to the distribution of temperature-sensitive pharmaceuticals. Global experts will also address the current risk-based regulatory environment and how it is affecting Cold Chain Management processes. In addition, members of the PDA Pharmaceutical Cold Chain Discussion Group (PCCDG) will examine PDA Technical Report No. 39 – 2007 Revision, Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment – a guide for regulators and the international pharmaceutical industry on the essential principles and practices for shipment of products which require controlled temperatures during transit.This will include harmonization with our European colleagues from the Cold Chain Committee (C3) and the Pharma Logistics Forum (PLF). Attendees will also learn how they can influence the future of Cold Chain Management by getting involved with the PDA Pharmaceuticals Cold Chain Discussion Group (PCCDG), and the formation of the Temperature-Controlled Pharmaceuticals Group (TPG), which includes the PCCDG, the Cold Chain Committee (C3) and the Pharma Logisitics Forum (PLF). Take-Home Benefit Develop a clear understanding of the current regulatory environment in the Cold Chain area Implement the principles of Component Qualification, Operating Qualification and Performance Qualification to establish greater assurance of quality throughout the Cold Chain process Summarize the role of stability data in supporting Cold Chain transportation Explain US and non-US regulatory expectations for Cold Chain Management Compare the latest regulatory observations regarding Cold Chain Management Establish a cooperative relationship between Cold Chain solution providers and Supply Chain partners with the manufacturers of the temperature-controlled medicines Who Should Attend Department Operations | Regulatory affairs | Manufacturing | Transportation | Packaging | Quality assurance/control Job Function Manufacture of temperature-sensitive materials | Transportation of temperature-sensitive materials | Packaging engineers | Stability coordinators | Supply chain | Logistics | Cold Chain service provider Contact For conference information, contact: Jason Brown Senior Programs and Meetings Coordinator Tel: +1 (301) 656-5900 ext. 131 E-mail: brown@pda.org For exhibition and sponsorship information, contact: Cindy Tabb Senior Manager, Membership Services and Sales Email: tabb@pda.org Tel: +1 (301) 656-5900 ext. 222 Nahid Kiani VP of Membership Services and Sales Tel: (301) 656-5900 ext. 128 Fax: (301) 986-0296 Email: kiani@pda.org For more information about obtaining a U.S. visa, visit http://www.unitedstatesvisas.gov.