Adoption of the E2B (R3) electronic submission format for individual case safety reports (ICSRs) will require a significant effort from drug safety departments. E2B (R3) introduces a number of new concepts which would necessitate changes to the scope and granularity of the safety case data collected. In addition, companies will have to enable processes and PV systems to maintain coexistence of E2B (R2) and (R3) for the transition period. Companies will also need a strategy around implementing the new ISO IDMP (Identification of Medicinal Products) standard for their products, to allow identifying products and substances in the E2B (R3) message using this new standard.
With potential adoption by regulatory authorities becoming a reality soon, businesses need to start planning their journey toward E2B (R3) compliance at the earliest. With planning, companies may also utilize this opportunity to also review processes and systems to achieve further efficiencies in their safety processing.
Please sign up below to view this webinar to understand the various challenges, opportunities and planning needed as you embark on this compliance journey.