Module 12 2019

Module 12: Data Management and Digitalisation in Regulatory Affairs

Lincoln Plaza Hotel, 2 Lincoln Plaza, London E14 9BD

Module Leader(s) : Nancy Pire-Smerkanich – DRSc, International Center for Regulatory Science, University of Southern California, USA

Date: Wednesday 20 th November 2019

Time

Activity

Speaker

16.00

Registration

16.15 – 16.30

Welcome & Introduction to Module 12

Nancy Pire- Smerkanich

Module Leader

Nancy Pire-Smerkanich University of Southern California

16.30 – 17.30

Lecture 1: Data Management and Data Governance (DM/DG) • Background, History and Legal Basis o Electronic Data Capture (EDC) o Data Input/Output o Data Querying o Data Management Plans • Data Standards • Regulatory Involvement in DM/DG

Workshop/Activity

17.30 – 18.30

Lecture 2: Document and Information Management • Document Archiving • Registration Tracking • Trial Master Files • Collaborative Authoring

Rohit Malhotra Biogen Idec