Ensuring Global Regulatory Compliance for Product Registrations: Strategies for Risk Reduction and Operational Efficiency
Event Date: June 11, 2013 at 02:00 PM EDT

Managing product registrations with numerous regulatory agencies, each with its own requirements, can be a challenge. Optimizing a quality management system to ensure regulatory and corporate compliance for product registrations for new and existing drugs in new geographic markets is crucial for commercial success. 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 new 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.

Key Learning Objectives:

• Learn how to Improve cycle time of approvals by ensuring accurate data and streamlined management of registration data and correspondence activities
• Gain insight on ways to optimize regulatory affairs workflow
• Understand ways to integrate other processes such as change control, document management pharmacovigilance reporting and Annual Product Reviews


Patricia Van Arnum

Executive Editor
Pharmaceutical Technology


Jake Doran

IT Director, Global Regulatory Affairs
Janssen R&D

KR Karu
Industry Solution Director, Pharmaceutical Sciences
Sparta Systems

Ashley Watkins
Industry Solution Manager, Pharmaceutical Sciences
Sparta Systems

This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Sara Barschdorf, sbarschdorf@advanstar.com.

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