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Best Solutions for Master Data Management
Session Chair(s)
Francisco Penaranda Fernandez
Head of Department, Business Data and Analytics
European Medicines Agency, Netherlands
Industry and Regulators will face new challenges (globalisation, personalised medicines, new technologies, transparency/access, etc.) in the coming years while the old product continues (i.e. lack of regulatory capacity, need for new skills, international collaboration and harmonisation, etc.). Identification of Medicinal Products (IDMP) is much more than a legal compliance project - it is an opportunity to develop a new way of conducting business as well as a new way for designing the process in, and defining the culture of, an organisation. Through IDMP we can redesign many of our current business processes, while increasing the provision of timely, accurate, and re-usable master data.
Learning Objective : Understand the importance of business critical data shared across Clinical Development and of major relevance for other functions such as Regulatory and Safety. Learn how governance can improve end to end handling of the key business elements relevant in the Pharmaceutical industry. Embrace Master Data Management to help eliminating operational inefficiencies.
Speaker(s)
Master Data in Global Clinical Development Operations, an Opportunity to Improve Operational Efficiencies
Guido Claes, MD, MSc
Janssen Research & Development, Belgium
Director Master Data Standards
NDC, the unique identifier for drugs in the U.S.: Past, Present, Future
Leyla Rahjou-Esfandiary, PharmD
FDA, United States
Lead CSO, Office of Compliance, CDER
Why IDMP Will (and Should!) Act as a Catalyst for Change across your Entire Organisation
Michael Braun-Boghos
Oracle Health Sciences, Germany
Director Safety & Analytics
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