How aligned are your relevant functions (e.g.,safety, commercial, compliance, finance, legal, quality),
and are governance processes in place to support clear accountability and appropriate program design, implementation, and oversight?
Themes from past experience
Scope and risk are typically underestimated.
Safety information comes from unexpected sources (social media, website comments, market research, vendor invoices, etc.).
Program ownership and accountability are often unclear, and requisite cross-functional processes and governance are not always consistent or in place.
Regional differences in culture, regulations, safety reporting practices, governance/oversight and more can result in unanticipated and varying levels of risk exposure.
Legacy product programs present similar (or greater) risk but are not always subject to similar oversight.
Training/re-training provided to marketing staff and vendors is frequently not focused or easy to understand.
Corporate culture plays a critical role. Senior executives must be engaged and actively communicating the importance of safety reporting and the related risks of noncompliance.
Addressing customer engagement and safety compliance
Rapid assessment of program inventory, training, implementation, oversight and governance processes
through the use of advanced analytics and other enablers. Develop data playback to inform next steps
and key areas of risk (e.g., specific geographies, products, program types).
Based on most significant areas of risk exposure, identify gaps between current state and compliance
requirements and conduct root cause analysis to determine remediation needs.
Incremental or systemic design and implementation of sustainable solutions that may include data capture. transfer and analysis processes, governance, controls, managed services, and/or technical enablement.
Monitor ongoing compliance with process and evolving regulatory requirements