21 September - 14.00-15.00 BST

Setting up effective governance that will enable a life sciences organization to truly use data as a strategic asset is complex and can be incredibly time consuming. A global pharmaceutical organization faces various challenges like identifying data owners, maintaining compliance across systems and functional areas, and mapping source data to regulatory standards. 

In this webinar, leaders from Bristol Myers Squibb and SPORIFY will discuss how data governance and reference data management connect to an organization’s strategic goals. Presenters will share project learnings and look at the role technology can play in simplifying data management and creating efficiencies. To illustrate the link between reference data management and a specific regulatory objective, they'll speak to the ongoing implementation of the IDMP standard through SPOR data in the European Union (EU) as an example. 

Learning objectives  
• Understand the challenges and learnings associated with data governance and reference data management
• Hear how a global pharmaceutical company approaches data management in the context of strategic goals and decision making
• Learn about the role technology plays in initial data mapping and ongoing maintenance
• Get an update on the EMA's IDMP implementation and the use of SPOR for regulatory activities 

Target audience 
• Regulatory Affairs professionals
• Regulatory Operations professionals
• xEVMPD and IDMP project managers
• Master and Reference Data Management
• Anyone involved in data strategy, standards and governance

Presenters
• Isabel Esteve, Associate Director, Global Regulatory Business Capabilities Strategist – RISM, Bristol Myers Squibb
Isabel started her professional career working at EMA as a Scientific administrator in H-Quality of Medicines.  She joined Bristol Myers Squibb in 2012 as part of the European Regulatory team, working on Virology, Immunology and Oncology portfolio as well as in early development assets; In parallel she was also involved in the implementation of our RIM system. In June 2019, Isabel relocated to the United States and joined the Regulatory Information Submission Management team where she is leading the IDMP Business Process Implementation (current role)

• Rishma Ulrich, EVMPD / IDMP Operations Manager, Regulatory Information and Submission Management, Bristol Myers Squibb
Rishma leads the EVMPD and IDMP Operations teams at Bristol Myers Squibb and is a member of the SPOR Key User Group, which discusses topics on SPOR data governance and standardization with industry, NCAs, and EMA representatives in preparation for IDMP implementation.  Prior to joining BMS, Rishma led Global Process Development and Pilot Plant Operations at Revlon and held various process engineering roles within L’Oréal and Anheuser-Busch. Rishma holds a bachelor’s degree in chemical engineering from The Pennsylvania State University.

• Gary Wilson, Vice President Reference Data Management, SPORIFY
Gary is Managing Director & Co-Founder of CorrIT, now an ArisGlobal company, and creator of the SPORIFY web application. Gary holds a BSc (Hons) in Computer Science and has over 18 years industry and consultancy experience. Since the launch of SPORIFY in 2017, CorrIT have assisted many organisations and regulators with their implementation and integration of SPOR Master Data Services as they move towards IDMP in Europe and has a sharp focus on a data first approach with global reference data management and interoperability of systems. Gary is a member of the SPOR Key Use Group and IDMP inter-association group.
 
This webinar is sponsored by ArisGlobal.

Disclaimer: Whilst TOPRA is running this webinar for ArisGlobal, this is not an endorsement of ArisGlobal, ArisGlobal's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

• Members: free
• Non-members: free

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