Major life sciences roundtable debate reveals growth in regulatory outsourcing

Growth due to increasing complexity around affiliates’ roles.

The PLG Evolve roundtable debate, Brave New World: Outsourcing and the Changing Role of the Affiliate, brings together senior representatives from Merck, LEO Pharma, AbbVie, Sanofi and Lundbeck. During this seminal session, they debate the conflicting needs of local sales operations and corporate RA teams, and the role of specialist external services in helping to bridge these differences.

The panelists discuss variants in affiliate operating models, and explore how an outsourced approach to managing local regulatory activities, as well as safety documentation and managing safety case reports, can help overcome current challenges, enabling in-country affiliates to focus on building the business unfettered by administrative bureaucracy, while ensuring the quality, consistency and transparency needed at a corporate level to achieve compliance.

In the words of panellist Jesper Kihl, Vice President for Global Regulatory Affairs at LEO Pharma: “The environment in which we operate has become far more complex, margins are being squeezed, and room for manoeuvre is shrinking. Affiliates need to focus on commercial activities, so outsourcing regulatory, pharmacovigilance, and other activities, makes sense.”

The PLG Evolve virtual discussion covers concerns about and first-hand experiences of outsourcing affiliate RA and pharmacovigilance documentation activities, including the learning curve involved when shifting from internally managed processes to the outsourcing of affiliate administrative activities.