Module 12 Presentations

Typical example sources to be monitored

• Health Authority websites (such as EMA, FDA, Swiss Medic, etc.) to monitor updates in regulatory Requirements and latest developments

• Global drug dictionaries from WHO-UMC

• IRISS forum, UNICOM and Industry roundtables

• Technology vendors developing Reg. Intel. tooling (e.g., in RIMS)

• Newsletters from different Regulatory sources

• External Industry/Health Authority Working Groups (e.g. International Council for Harmonization (ICH))

The Organisation for Professionals in Regulatory Affairs