Brexit Impact on Global Regulatory Affairs Department Processes and Systems

Context:

The project took place within a British multinational pharmaceutical company and world leader on the vaccines market.

Belgium hosts its Global Vaccines Headquarters, which manages a portfolio of over 40 different vaccines for children, adolescents, adults and travelers. This company has therefore its main manufacturing sites located in Wavre, producing over 2 million doses of vaccines every single day, from which 99% are exported to more than 160 countries around the globe.
Considering the importance of the UK market for the company, Brexit represented a major business disruption risk. Indeed, its licenses to supply vaccines to the UK market depended on European procedures defined by the European Medicines Agency (EMA). Hence, with Brexit looming around, there was an opportunity for the Medicines and Healthcare products Regulatory Agency (MHRA, the British medicines agency) to define different regulatory requirements that would invalidate its licenses and prevent the company to supply vaccines to the British market. As a result, the Global Regulatory Affairs needed to reengineer their processes and reconfigure their systems, for which Phinest was mandated.

 

Our Motion:

Phinest was responsible for:
• Defining and modeling of “AS-IS” context, i.e documenting existing processes and systems’ configuration
• Gathering requirements from large group of stakeholders coming from Regulatory, Legal, Supply Chain, Quality and IT departments.
• Providing Regulatory Senior Directors with strategic scenarios, as Brexit negotiations were still ongoing
• Designing and modeling the “TO-BE” processes and systems’ configuration
• Coordinating the implementation of the “TO-BE” solution
• Defining the Change Management approach and Communication strategy for 500+ impacted stakeholders

Impact:

Phinest achieved:
• The implementation of the new process and systems’ configuration without compromising business continuity, allowing regulatory information to flow to Supply Chain and Quality departments for the supply of vaccines to the UK market
• Coordination of onshore and offshore business and technical teams
• Delivery of communication and training material to Global Regulatory Affairs and external department to ensure business continuity (500+ employees)

Thomas Tassenoe
Thomas Tassenoe

Phinest Consultant