R3 is coming: Are you ready?
By: Paul Kelly | December 08, 2016
How a new regulatory update will change the way companies file safety reports – and what to do to prepare.
The latest ICH E2B (R3) standards will have a major impact on biopharmaceutical companies’ pharmacovigilance systems and processes, particularly on adverse event reporting and collection of data on drugs. Companies will be required to overhaul several key individual case safety report (ICSR) processes and procedures to prepare for the rapidly-approaching deadline for implementing these new standards. Biopharma companies need to start working on transition plans as the integration process will require time, training and a shift in culture.
In November 2012, the updated E2B (R3) standard reached step 4 at the International Conference on Harmonization (ICH). This was an update to its standard for electronic transmission of ICSRs. The original standard, E2B (R2), was implemented in 2001, and there have been many changes in regulatory reporting requirements and pharmacovigilance practices since that time. The new R3 update features many adaptations intended to simplify the exchange of information across regions and stakeholders, while improving accuracy and the level of detail in the information collected.
At a broad level, there are more data elements in the new version than the old. The R2 format had 271 unique data elements with the average file using 120-150 of them. In R3, there are 333 unique data elements -- 38 of which are new, and 33 of which have been altered. The increase in data elements may potentially impact the time it takes to process an ICSR in a safety database and additional time may be required to verify that data in source documents have been transferred to the safety database.
Along with more data elements, there are changes in the way information is shared and coded, and the extent to which explanations can be included. Some most significant changes include:
To adapt, pharmacovigilance business leaders should assemble a transition team that includes subject matter experts from all impacted areas who can put together an integration plan and communicate the necessary changes to key stakeholders. That plan should include technology upgrades, form revisions, governance strategies, and training for all affected employees to ensure their people have the tools and knowledge they will need to adapt to the new standard. These transition plans shouldn’t be limited to internal stakeholders. To be effective, companies also need to work with vendors and partners to develop an updated model for information exchange that is clearly written into a contract, and establish standard operating procedures for data collection and reporting to ensure every aspect of the clinical research environment is compliant with the new R3 standard.
Timing for compliance to the new E2B (R3) standard varies across regions.
While there is still time for companies to adapt their current safety reporting strategies to accommodate the new standard, time is quickly running out. In a recent webinar on this topic hosted by QuintilesIMS, almost half (46 percent) of participants said their companies had not yet considered the need to develop an E2B (R3) implementation plan. We recommend companies start as soon as possible, as integration of this new standard to safety reporting submission practices will require a substantial culture change, along with training and system assessments across multiple teams.
This transformation will take time and effort, and biopharma companies need to start now. Companies that are concerned about implementing this transition process, should reach out to their partners and vendors who understand the intricacies of the new standard to help them develop a plan to meet looming deadlines for compliance.