Discussion to Address Emerging Standards, New Regulations and Best Practices in Changing Data Environment
The DIA conference EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context will explore how to manage electronic clinical data that are generated in the course of the drug development life cycle while adhering to changing regulatory standards. The meeting, to be held Oct. 15 to 17 in San Diego at the Town and Country Resort Hotel, will share key knowledge on navigating the evolving environment of Electronic Document Management (EDM), and the Electronic Regulatory Submission (ERS) and Electronic Common Technical Document (eCTD) processes.
“Data sharing and data protection are becoming more complex with advances in technology, new regulation standards and the increasing volume of information generated from the drug development process,” said Susan Cantrell, director of DIA North America. “This conference aims to educate professionals managing and submitting data on how to streamline data management and submission to accelerate drug development in the regulatory framework.”
Thought leaders in electronic data management on the drug development continuum will discuss how to address challenges to best:
- Ensure compliance.
- Optimize working with contact resource organizations and cloud computing.
- Maximize content reuse and metadata.
- Explain current Food and Drug Administration (FDA) and global regulatory agency requirements and future initiatives.
Panels and speakers will include:
- FDA Update/eCTD Progress Report, Oct. 15, 1:30 p.m.: The FDA regulatory update will be presented by Gary M. Gensinger, deputy director of the Office of Business Informatics, Center for Drug Evaluation and Research, FDA. Mark Gray, director of the Division of Data Management Services & Solutions, FDA, will provide an update on current requirements for eCTD management and submissions.
- Managing Global Labeling Content Alignment, Oct. 16, 10:30 a.m.: Ensuring the accuracy of information intended for regulatory submission is a challenging process that involves the merging of global organizations, functions, regions, languages and systems. Chaired by Laura J. Sherman, training partner of clinical business operations, Vertex Pharmaceuticals Inc., the session will present examples of regulatory audit requests, and reveal how to navigate prescribing and patient information to ensure that labeling data is consistent and accurate.
- A Career in Submission Production and Support, Oct. 16, 1:30 p.m.: A career in regulatory submissions operations is a lucrative and respected profession, requiring a diverse set of technical and business skills. Christian A. Buckley, associate director of regulatory affairs submissions for Astellas Pharma Global Development, Inc., will discuss career experiences with various esteemed professionals and provide advice for boosting professional development in the submission production and support arenas.
- When Worlds Collide — Information Management Challenges in 21st Century Mergers, Acquisitions and Partnerships, Oct. 17, 10:30 a.m.: Joseph A. Cipollina, director and e-strategy liaison at Bristol-Myers Squibb Co., will explore various aspects of managing the exchange, sharing and consolidation of information between merging companies and developing partnerships.
DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org