Bethesda Marriott, Bethesda, MD USA
Oct 13 2011 8:00AM - Oct 14 2011 3:00PM
2-Part PRECONFERENCE WORKSHOP — October 12 Half Day Part 1 — Development and Updates of Core Labeling This part of the workshop will describe the Company Core Data Sheet (CCDS), how it can be structured to address labeling requirements worldwide, and how it is used to define Company Core Safety Information. Options for processes and business rules for developing and updating the CCDS and implementation in local labeling will also be discussed. This will be followed by a breakout session, where teams will be organized and provided examples of different topics to determine if the topic should be added to the core labeling, and what is the most appropriate section of the core labeling for the information. Part 2 — Labeling Auditing This part of the workshop covers the labeling auditor’s approach to local implementation of core labeling. Processes, procedures, and key elements for performing audits will be discussed, as well how to prioritize and report them. The program will also discuss how to prepare to be audited. Main Conference — October 13-14, 2011 This conference will discuss conceptual and practical approaches to global and regional harmonization of labeling for prescription drugs/biologics, non-prescription drugs, medical devices and other products such as nutraceuticals. Event Code: 11022
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Registration:
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Event information Contact Colleen Braun, Program Manager, Phone +1.215.442.6160 Fax +1.215.442.6199, email Colleen.Braun@diahome.org Tabletop Exhibit information Attendees may visit the tabletop exhibits during the event and receptions. Contact Shannon Lewis, Exhibits Associate, Phone +1.215.442.6149 Fax +1.215.442.6199, email Shannon.Lewis@diahome.org
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