Module 12 2019

RIM Categories

1)

Dossier Management (content plan, distribution, archive);

10) Submission Production (assemble, publish, QC, dispatch); 11) Design History File – Medical Device 12) Data Management and Information Standards (IDMP, UDI, EUMDR, etc.); 13) Regulatory Intelligence; 14) Safety Reporting; 15) Connection Point: Manufacturing Product Change Control; 16) Connection Point: Product Supply Release;

2)

Health Authority Interactions (Q&A, correspondence);

3) 4)

Health Authority Commitments;

Labelling (core data sheet, eIUF, compliance tracking, artwork);

5) 6) 7)

Product Registration Management;

Regulatory Archive;

Reporting and Analytics / Integrated Regulatory Information View; Submission Forecasting (demand for next 12 months);

17) Connection Point: Clinical; 18) Connection Points: QMS.

8)

9)

Submission Document Management;

Reference: Gens & Associates: World Class Regulatory InformationManagement Whitepaper; Connections to Supply

Release, Product change and QMS. 2018 Fall Edition

The Organisation for Professionals in Regulatory Affairs