Module 12 Presentations

Regulatory information throughout the product lifecycle

Technology

Submission Planning & Tracking

Dossier Planning & Strategy

R&D

Clinical

Health Authority Interaction

Submission Forecasting

Registration Management

Release

Publishing

Submission

Manufacturing

Pharmaco vigilance

Regulatory Affairs

Pharmaco vigilance

Regulators

Manufacturing

Clinical Pharmacovigila nce

R&D

Manufacturing

Labeling

Platform : Most of the core RIM capabilities are available in platforms, but several years away from mature publishing and label compliance tracking capabilities that can compete with the best-of-breed providers

The Organisation for Professionals in Regulatory Affairs