The next generation of Regulatory Document Management is here!
Sponsored by: AMPLEXOR Life Sciences
- C M S
- D M S
- E C M
- B P M
Date: 5 April
Time: 3PM London/10AM New York
Integral Document Management System
A majority of currently used Document Management System have been fossilized in many companies while the needs of changing business processes and regulatory demands have increased. The next generation of EDMS builds critical processes around products not documents. Document Management needs to be part of a holistic Regulatory and Quality Information Management solution supporting Marketing Authorizations and orchestrated by easy to apply Change Controls on any level. This should enable risk-based validation of the system. The demands for greater granularity of content and data is required by the authorities. The segmentation between Document Management and Publishing has been disappearing.
A new demand for global context requires the direct involvement of local affiliates as an integral part of these critical global processes while not losing the requirements for local needs. Governance of content and data in such an environment needs to be re-thought to eliminate the requirements for manual interventions. When the DMS is built with a new "integral" architecture, it is conceptually part of the next generation RIM (as described by GENS & Associates), reusing master regulatory and quality data not only for Document Management, but also for other modules like RIMS, XEVMPD/IDMP, Publishing, ERP and others.
The new architecture enables the management of all related content in context with product data, which then will be shared with each solution module. Every document and every related data object has its regulatory history, allowing impact assessment in both a local and a global context. This allows for optimal automation of document creation and processing. A DMS architecture in this new "integral" design, will reduce dramatically the upgrade and validation effort.
VP Strategy, Life Sciences
Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in the Life Sciences industry. Romuald has been playing roles on the client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server and in cloud environments, in Europe and in US.
Romuald is holding the academic degree of Master of Drug Regulatory Affairs in addition to his Engineer diploma in Data Technology. Romuald has been also a frequent speaker on topics relating to content management adoption in life sciences.
Director of Products, Life Sciences
Within 9 years at AMPLEXOR (former INFOTEHNA), Renato Rjavec managed several implementations of integral regulatory and quality management solutions for pharmaceutical companies of all sizes, as well as regulatory agencies.
For the last 2 years, he has been product manager of the Life Sciences Suite, responsible for market analysis, product definition and management of the release cycle. He has recently been appointed as Director of Products at AMPLEXOR Life Sciences.
Key Learning Objectives
- Recognize the value and business potential of this next generation "integral" DMS
- Understand the difference between traditional EDMS systems like CSC FirstDoc, IBM Score, Veeva Vault, EMC D2 and the new "Integral" DMS
- Follow a suggested migration approach from legacy DMS to the new "integral" solution
- Create your own assessment to include your own preferences to deploy on- or off-premises, to the cloud, and/or to a shared infrastructure
- Pharmacovigilance Professionals
- Clinical Development Professionals
- IT Managers in Life Sciences Companies
- Data Consultants in Life Sciences Companies
- Submission Responsibles
- Project Managers in Life Sciences Companies
- Global Regulatory Affairs Professionals
- Patient Advocates
- Global Labelling Professionals
- Research and Development Professionals
- Quality Assurance/Quality Control Professionals
- Corporate Executives