Labeling Harmonization – 2011: How Close Are We To Harmonized Safety Labeling Strategies for Compa

Venue: Bethesda Marriott

Location: Bethesda, Maryland, United States

Event Date/Time: Oct 13, 2011 End Date/Time: Oct 14, 2011
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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

• Design and Use of Core Labeling as a Tool to Achieve and Maintain Global Labeling Consistency
• Design of Corporate Labeling Policies and Processes and the Need for Convincing Supporting Documentation
• Implementing Core Labeling Updates across all regions
• Regulatory Authority perspectives and approaches taken to harmonize labeling
• Core Labeling for OTC Products, Medical Devices, Nutraceuticals, etc.

Target Audience:
Professionals involved in:
• Clinical Safety/Pharmacoepidemiology/Pharmacovigilance
• Regulatory Affairs/Labeling
• Clinical research & development
• Product research & development alliances
• Quality control/assurance
• Information technology/eBusiness
• Policy/Drug or device approval/Good review processes
• Regulatory and medical communication scientists

Event Code:


Additional Information

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