The year 2020 brought a seismic shift to the biopharma ‘Business as Usual’ operating model in safety and pharmacovigilance (PV). International government-imposed restrictions went into effect—driving employees from office-based to remote working modalities. Pressure to expedite the approval of safe and effective vaccines placed an enormous burden on regulators, health care professionals, and license holders to ensure real-time monitoring of emerging safety data related to COVID-19 medications and vaccines.

Today, multiple vaccines and treatments are rolling out globally under Emergency Use Authorizations (EUAs). Following record-breaking, accelerated development, there is increased emphasis on post-marketing surveillance to track immediate and longer-term safety events and implications. The logistics and sheer global volume of COVID-19 safety information requires new approaches and solutions. Rapid processing of adverse events, early signal detection and immediate follow-up are critical to building and maintaining public trust and ensuring the long-term viability of vaccination efforts.

Successfully scaling to handle this level of post-marketing surveillance has required massive and continuous changes in operational approaches involving people, processes and technology. The velocity of safety transformation has precipitated many changes that will live on well past the pandemic itself.

This webinar will cover:

• Evolving best practices in business continuity and workforce management

• Innovative ways of handling and adapting to rapidly changing regulations and massive volume increases

• Approaches to continuous process innovation

• Successfully implementing technology innovations

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Speakers:

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