Highlight Topics:

  • Integrating eTMF and enterprise content/ document management
  • Interoperability (e.g. eTMF with eTMF, eTMF with eDM, eTMF with data warehouse)
  • eSubmission (eCTD 4.0)
  • Portals, common repositories and gateways
  • Maintenance of XEVMPD and labelling management
  • Preparing for IDMP
  • Outsourcing and Infrastructure
  • CRO Integration of processes
  • Outsourcing and Infrastructure

Keynote Presentation

Regulatory Information Management (RIM) versus Master Data Management (MDM) – Opportunities and Challenges on the Journey to Content-driven Authoring

Master Mata Management (MDM) comprises the processes, governance, policies, standards and tools that consistently define and manage the critical data of an organization to provide a single point of reference. The objective of MDM is to provide a unique foundation for collecting, aggregating, matching, consolidating, quality-assuring, persisting, and distributing reliable data. As a consequence, MDM is a discipline for quality improvements supported by data governance processes and organizations. The ultimate goal being to provide the end user community with a "trusted single version of the truth" from which to base decisions.

Regulatory Information Management (RIM) is the business practice in the pharmaceutical industry involved in the development, capture, dissemination, control and management of regulatory-focused content, throughout all product lifecycle stages. RIM has been challenged by permanent changes of regulatory standards resulting in higher data delivery needs to agency, for instance by recent XEVMDP or ISO IDMP. On the one hand, the above definitions inherently substantiate a correlation, as proper Regulatory Information (RI) relies on proper Master Data (MD). On the other hand, RI can also become MD itself. The questions that arise are: how can boundaries and synergies be identified and utilized? What setups would allow mutual leveraging in order to positively impact business process designs to increase and sustain a company’s competitiveness and efficiency? 

Speaker: Romuald Braun

Location

Hotel Holiday Inn 

Haagse Schouwweg 10

2332 KG Leiden

Netherlands

Photos







Anne Ertle at AMPLEXOR Life Sciences booth