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We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.

EMA electronic Product Information (ePI) Consultation

Expert and public comments sought on ePI, open until 31/July/2021. The EMA has opened a public consultation on the draft EU common standard for electronic product information or ePI. The consultation period is open until end of July 2021 so there is little time left to give feedback. Comments should be provided via an online …

EU pilot project ‘Market Launch of Centrally Authorised Medicinal Products’

Action required: Pilot started 25/March/2021. In March 2021 the European Commission, together with the EMA and Member States, committed to initiate a pilot to better understand the root causes of deferred market launches for centrally authorised products. The initiative has been launched with the engagement of future Marketing Authorisation Holders (MAHs). The pilot’s overall objective …

Can our four-legged friends help us get out of the COVID-19 pandemic?

Dogs are well known for their abilities to sniff out drugs even when hidden in the most concealed containers. K-9s assist humans worldwide by supporting the visually disadvantaged, hearing impaired and diabetic patients and they are well known to many of us undertaking security checks on airports. In more recent years though dogs are also …