Key Ways for Ensuring Global Regulatory Compliance

June 5, 2013
Patricia Van Arnum
Pharmaceutical Technology

International markets play an important role in pharmaceutical and biopharmaceutical companies’ growth strategies, and it is crucial that companies meet the challenge of global regulatory compliance.

 

International markets play an important role in pharmaceutical and biopharmaceutical companies’ growth strategies, and it is crucial that companies meet the challenge of global regulatory compliance. Optimizing a quality management system to ensure regulatory and corporate compliance for product registrations for new and existing drugs in new geographic markets is essential for commercial success. Pharmaceutical Technology will examine the operational, organizational, and technological-based requirements on how to reduce risk and achieve operational efficiency for global product registrations in a live webcast on Tuesday June 11 from 2:00 to 3:00 PM EST.

Managing product registrations with numerous regulatory agencies, each with its own requirements, can be a challenge. The webcast will feature industry experts, who will share their insight on how to create a robust quality management system for complying with country-based and regional-based regulatory requirements for new product registrations, product changes, and labeling changes. The webcast will further examine how to use automation for effectively tracking product registration and related correspondence to ensure global regulatory compliance.

Speaking at the webcast will be Jake Doran, IT Director, Global Regulatory Affairs, Janssen R&D; KR Karu, Industry Solution Director, Pharmaceutical Sciences, Sparta Systems; and Ashley Watkins,Industry Solution Manager, Pharmaceutical Sciences,Sparta Systems. The panelists will provide insight on how to optimize the regulatory affairs workflow, improve cycle times of approvals through better management of registration data and correspondence activities, and how to integrate other processes, such as change control, document management, pharmacovigilance reporting, and Annual Product Reviews

Audience members will be able to ask the panelists questions. The live webcast will be on June 11, 2:00 to 3:00 PM EST with on-demand viewing available thereafter. Information on how to register for the webcast may be found here.