Global Forum: Regulatory Roundup, Ringing in Regulatory Changes

Author:

Joel Finkle, Senior Strategist, CSC's Life Sciences Group

As the New Year begins, the latest moves to harmonize regulatory requirements internationally point to new opportunities for life sciences companies – so long as they’ve updated their own processes and systems. The International Conference on Harmonization (ICH) has brought greater cohesion in the way regulatory submissions are managed across the US, the European Union and Japan. Yet differences in interpretation remain involving submission formats such as the electronic Common Technical Document (eCTD). The only sure way forward for companies in the meantime is to ensure submissions can conform to the evolving formats, standards, and regulations of the respective authorities.

Download Full Article:
Global Forum: Regulatory Roundup, Ringing in Regulatory Changes
(1,811 KB)

Questions: Contact us