Module 12 2019

©TOPRA ( The Organisation for Professionals in Regulatory Affairs) 2019

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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

Module 12: Data Management and Digitalisation in Regulatory Affairs

Date : Thursday 21 st November 2019

Time

Activity

Speaker

09.00 – 10.30

Lecture 3: Electronic Common Technical Document • Update on Worldwide Use • Current Technical Specifications • Electronic applications forms (eAF) • eCTD Demo • Future version of eCTD

Remco Munnik Iperion

10.30 – 10.45

Refreshment Break

10.45 – 12.00

Lecture 4: US Regulatory Requirements • US Data Standards and Resources • CDISC o ADaM o SEND • Reviewer’s Guides • Data Traceability and Accountability • eLabeling - SPL • US FDA KASA System

Nancy Pire-Smerkanich University of Southern California

12.00 – 13.00

LUNCH

Remco Munnik

13.00 – 14.45

Lecture 5: EU Telematics Strategy • Update on 2025 Roadmap • Collaboration with EMA and National HAs

Iperion

EMA SPOR

14.45– 15.00

Refreshment Break

Remco Munnik

15.00 – 16.00

Lecture 6 : Technical Specifications and Compliance • eLabeling and ePI • xEVMPD and ISO IDMP Regulatory Information, Intelligence and Knowledge Management • RIM Systems and Capabilities • Regulatory Intelligence • Regulatory Knowledge and Management o Administration o Systems

Iperion

16.00 – 18.30

Rohit Malhotra Biogen Idec

Module 12: Data Management and Digitalisation in Regulatory Affairs

Date: Friday 22 nd November

09.00 – 10.30

Lecture 7: Data and Document Best Practices and Process • Ensuring Compliance • Role of Regulatory Affairs Professional

Nancy Pire-Smerkanich University of Southern California

Process and documentation workshop

10.30 – 10.45

Refreshment break

10.45 – 12.15

Lecture 8: The Look to the Future • Automatic processing and Data mining (PV and ICSR)

Elspeth Gray MHRA

Machine Learning Artificial Intelligence

• • •

Big Data

RWD/E

12.15 – 13.15

LUNCH

13.15 -15.00

Workshop