Module 12 2019

Communication Processed by RA then disseminated to systems

G-SRS

Molecule Data

API Discovery

Regulatory Affairs/Strategy

Regulatory Data Lifecycle (V. Perkins, Bayer)

SmPC

Specs

Scientific Content Created

RIM

Company Core Data Sheet (CCDS)

USPI

CMC

Labeling

Pre-Clin Clinical

ESG Regulatory Agency

Sponsor

Regulatory Operations

DMS/SharePoint/Fileshare

Compile Dossiers For Submission

Legal

Quality

Supply Chain

Pharmacovigilance

R/B Evaluation

Communications back to Sponsor

Decisions

Assess Content

Use Content for Reports and Correspondence

Evaluation of Product Info (Ad/Promo, Claim

Distribute to Functional Reviewers

ESG Regulatory Agency

Data for Customs or Market Regulators

Regulator

Populate Agency Databases

Validate

Data Needed for Inspectorates

Application Submission Received

Parse & Assign To Appropriate Division

The Organisation for Professionals in Regulatory Affairs