CRANFORD, NJ - January 31, 2017 - Paragon Solutions, a leading advisory consulting and systems integration firm specializing in the life sciences industry, will share its electronic document management and electronic regulatory submissions expertise at the DIA Regulatory Submissions, Information, and Document Management Forum (RSIDM), Feb. 6-8, 2017, at Bethesda North Marriott Hotel and Conference Center, North Bethesda, MD.
Focused on the latest directions in regulatory information management for business, regulatory information technical management, Identification of Medicinal Products (IDMP), structured authoring and eTrail Master File (eTMF) for leading life sciences enterprises, DIA RSIDM 2017 presents an opportunity for professionals in regulatory affairs and operations, regulatory information management, data management, regulatory standards implementation, clinical operations and more to discuss and learn about the latest strategies and best practices in support of essential document processes, quality assurance and compliance, document and eRecords management and vendor relationship management.
Paragon regulatory information experts will contribute during RSIDM in the following scheduled events.
Global Identification of Medicinal Products (IDMP)
RSIDM Conference Co-Chair Brooke Casselberry, Director, Paragon Solutions
February 6, 2017, 8:30 a.m. - 12 p.m.
Overview: IDMP is a significant undertaking, but it also presents opportunities in terms of how Regulators and Industry manage and share data, both internally and externally, to support master data management initiatives.
This short course is aimed at providing stakeholders with a foundational knowledge of IDMP to support practical implementation within their organizations. More specifically, the course will demonstrate applied strategies and technologies used for the implementation, address practical issues within the regulatory landscape, and show relationships with established processes such as eCTD, XEVMPD, and SPL.
Paragon's Casselberry is also serving as the session chair for the following:
- Session 3 Track 2: Master Data Managment and Business - Where the Two Meet: Hear approaches, strategies, and effects of utilizing Master Data Management, (driven by IDMP) to improve product master management, life cycle management, and the business impacts from these changes. Listen to the case studies on how a top five pharmaceutical organization has approached master data management, IDMP, and the business impacts these initiatives have had across the functional areas.
- Session 6 Track 1: Save $60 Million – The Easy Way: During this session we will explore the rounded experience of regulatory platform integration beginning with the RFP process, product selection, and change management, to go-live. You will learn useful tips in RFP development and execution, case-study in regulatory platform solution selection process, and change management engagement practices for successful implementation.
Leverage Technology for a Seamless Process Between Collaboration and Official Repositories
Presenter: Ty Molchany, Business Solutions Specialist, Information Management, Paragon Solutions
February 8, 2017, 10:30 a.m. – 12:00 p.m.
Overview: A unique approach to create a seamless process between “unofficial” collaborative authoring and document sharing environments to the official systems. Explain the importance of allowing the business to have an “unofficial” collaborative environment. Identify opportunities for automatic content enrichment when upgrading your collaboration (SharePoint) space to take advantage of out-of-the-box capabilities and configurations. Compare upgrade paths that will empower the business to better organize, find and take action on their content.
Why RSIDM 2017?
RSIDM 2017 is focused on describing organizational processes and governance to ensure integrity, quality, and security of records
- Discuss how to break down silos for end-to-end processing of regulatory information as it relates to EDM and ERS
- Envision the scope and future of IDMP with respect to systems, process, standards, and master data
- Discuss organizational implications related to increasing electronic interactions with stakeholders
- Explain ways to implement processes to improve communication of regulatory expectations and communications
- Interpret global health authority regulations and guidances for systems and processes
- Describe how to map eTMF capabilities to support clinical site inspections
- Identify techniques to create efficiencies in the overall end-to-end process of document and submission management
For more information on RSIDM 2017, click here.
About DIA RSIDM
DIA's Regulatory Submissions, Information, and Document Management Forum was initially three separate DIA meetings: EDM (Electronic Document Management), ERS (Electronic Regulatory Submissions), and RIM (Regulatory Information Management), each with their own unique histories. In 2015, those three meetings were combined into one forum in an effort to represent the end-to-end process of managing regulatory submissions and documents. The response to this approach has been incredibly positive with record attendance in 2016, as it serves as the premier place for the discussion of emerging operational standards, best practices, and the processes for submission, creation, and maximum use of regulatory information. The forum continues to explore information generated along the drug development continuum life cycle and alignment to ever evolving regulatory and electronic standards.
About Paragon Life Sciences Consulting Services
A practice domain of Paragon Solutions, Paragon Life Sciences expertise and solutions include clinical optimization, commercial consulting, corporate and enterprise solutions, quality and manufacturing services and regulatory optimization strategy and services. Paragon’s Life Sciences practice stems from decades of experience across the Life Sciences industry, resulting in a team with deep industry thought leadership that provide practical solutions to client problems by leveraging technologies from various technology partners.
About Paragon Solutions
Paragon Solutions is an advisory consulting and systems integration firm that specializes in enterprise information management to help clients leverage information assets for better business results. The company does this through its industry practices, solution accelerators and specialized technology competencies that help clients achieve operational efficiency, business scalability and regulatory compliance.
Paragon works with businesses that are focused in a few key industries − communications, financial services, healthcare, insurance, and life sciences. The industry-focused practices work with Paragon’s competency groups to address today’s client concerns in Process Optimization, Information Management and Information Integration. For more information, please visit the Paragon website at www.consultparagon.com, or call 1.800.462.5582. On social media, visit Paragon on Twitter @consultparagonor Paragon Solutions on LinkedIn and follow updates from Paragon on Facebook.