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Affiliates need to focus on commercial activities, so outsourcing regulatory, pharmacovigilance, and other activities, makes sense

A special PLG Evolve Webinar on April 12th will provide exclusive access to the debate between senior Regulatory Affairs executives from some of the industry’s biggest names

Paris, France – April 6th, 2016 – A major industry debate by a Who’s Who of the life sciences industry has revealed growing interest in outsourcing of Regulatory Affairs (RA) activities due to the increased complexity in the role of international affiliate organisations. The debate’s findings, which have been distilled into a summary paper published by outsourcing and consulting services specialist ProductLife Group (PLG), will be aired via an exclusive webinar on April 12th.

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.


• Regina Freunscht, Vice President, Head of Global Regulatory Affairs Operations & Global Regulatory Affairs Senior Vice President Office, Merck
• Jesper Kihl, Vice President, Global Regulatory Affairs, LEO Pharma
• John Kiser, Senior Director, Regulatory Policy and Intelligence, AbbVie
• Tobias Massa, PhD, Vice President and Head of Global Regulatory Affairs Operations, Sanofi
• Sybil Skinner-Robertson, Director, Regulatory Operations Region South, Europe, AbbVie
• Jan Vindberg-Larsen, Senior Director, Head of Global Regulatory Affairs, Lundbeck
• John Farrell, Chief Operating Officer, ProductLife Group

To register for the PLG Evolve Affiliate Outsourcing webinar, which takes place on Tuesday April 12th at 14:00 GMT/ 15:00 CET, go to
Those attending the webinar will receive a complimentary copy of the PLG Evolve roundtable discussion summary report, Brave New World: Outsourcing and the Changing Role of the Affiliate.

About ProductLife Group

ProductLife Group is a trusted partner that helps clients stay ahead of the changing R&D landscape. We provide support across all stages of the product life cycle and have experience in working with companies in every segment of the life sciences industry. With an established presence across Europe, North America, and Asia Pacific; with extensive capabilities in key markets; and with more than two decades of serving the industry, ProductLife Group has a solid platform from which to provide clients a range of services, consulting, and outsourcing solutions. ProductLife Group empowers clients to focus on innovation and business growth strategies and to make strong, informed decisions every step of the way. What’s more, we wrap it all up with partnership flexibility, for a truly customised experience that helps clients scale their initiatives cost-effectively.

By taking advantage of the power of deep domain expertise, established relationships, intelligent collaborations, and a flexible delivery framework, ProductLife Group delivers exceptional service to clients. Our goal is to develop long-term relationships by being responsive and relevant and by consistently delivering value. We cultivate a trusting, consultative environment and are positioned to operate as an extension of clients’ businesses, with a shared interest in their long-term success.

More at or follow us on Twitter at @ProductLife_EU

PR Contact:

Sarum PR – PR for ProductLife Group
+44 1722 322916

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