P224: Business Continuity Planning in Combating COVID-19 with Resilience: The Way Forward
Global Head of PV Compliance & Business Management
Otsuka Pharmaceuticals Europe Ltd. United Kingdom
Building operational resiliency to mitigate business disruptions and maintain critical business processes for minimizing the impact of COVID-19 on staff, premises, and assets.
The Global Pharmacovigilance (GPV) Business continuity plan (BCP) team met weekly to discuss the regional PV BCP operational status. In addition, the BCP team rolled out the share-point site survey platform to accumulate the regional office updates, concerns and appreciation from global affiliates.
Due to the advancing threat posed by COVID-19, Otsuka’s GPV team decided to invoke its BCP. Starting January 2020, most of Otsuka’s PV staff started to work from home as a precautionary measure to ensure safety of its employees.
The team continuously monitored 33 global PV affiliates, PV vendors and partners, thereby collecting data and guiding them through unprecedented times. All employees were encouraged to follow local government and management recommendations, including wearing masks at all times, using sanitizers, antiseptic tissues for self-cleaning and equipment/stationery, temperature checks at entry, increased cleansing frequency of the premises and limiting visits to affected areas.
Online LSM survey was conducted in April, June and December 2021 based on questions concerning: office status, criteria to open offices, affiliates impacted by recurrent COVID-19 waves, staff impacted, precautions taken and preventive measures implemented. The feedback received from the LSMs/affiliates was analyzed and acted upon accordingly.
Periodic updates from the LSMs were requested, including office status (open/close). Additionally, during the pandemic, general inspection updates and specific PV obligations were monitored and updated on a shared platform on a bimonthly basis to ensure that no regulatory requirement was missed.
The PV BCP team performed another important activity by creating PV BCP metrics (Dashboards, status of BCP invoke, list of open/close affiliates, list of participants in BCP drill, and the rest) and subsequently updating the LSMs.
All PV BCP actions that were launched for PV personnel, horizontal alliances and service providers are still being monitored by the PV BCP team. The team also shares regular mailers on a wide variety of topics relevant to the present scenario like COVID-19 vaccination, Creating a flexible work environment, Mental health issues amidst COVID-19, etc
COVID-19 not only triggered a global health crisis but also threw off the typical flow and pattern of work. The pandemic, on the other hand, prompted new ways of working and sparked new ideas in PV. Business continuity was critical during the epidemic, and it was a gigantic task to fulfill all reporting requirements along with taking care of global PV functions efficiently.
The PV BCP team's resiliency was continuously tested by rapid transformations, such as travel restrictions, and as large-scale remote working became a reality. BCP was efficiently used for alleviation of risks and strategies were planned that allowed services to continue. The problems included the requirement to respond to new scientific facts on a regular basis and the necessity to communicate ambiguity in real-time. PV BCP metrics were a new venture in this regard, that budded from the creative thinking of the PV BCP team to keep the LSMs and leadership updated about the PV BCP operations and measures.
Every week, the PV BCP team interacted with the LSMs to learn about their local policies, appreciate their efforts, and assure them of ongoing support. A logbook was constructed to ensure further improvement of the procedure based on present knowledge.
The PV BCP team rolled out the surveys for connecting with the LSM community at large and gathering regional updates, as well as any feedback that the affiliates / LSMs may have for the team. This survey helped the PV BCP team to bring in several changes and improvements in BCP processes and organizational aspects.