Module 12 Presentations

Data Standards as a Global Issue (Ref: VPerkins)

When no Common and Harmonized Data Standards Approach Exists…

• There is no possibility to exchange medicinal product information between regulatory authorities and pharmaceutical industry in a structured and efficient way • Difficulties in ensuring data consistency in evaluating and comparing medicinal product related information across regions, due to the lack of harmonized definitions of terminologies and data sets • Administrative burdens and duplication of efforts requiring substantial human and financial resources to comply with, and handle, different regional requirements

The Organisation for Professionals in Regulatory Affairs