Regulatory Mechanics Should be Outsourced & Affiliate Roles Redefined, Say 6 Senior Executives at the Frontline of Regulatory Affairs

Major life sciences industry roundtable featuring some of the biggest names in pharma highlighted the growing pressures on international operations & best practices for outsourcing RA processes

Paris, France – June 1st, 2016 – An unprecedented roundtable debate between senior regulatory affairs executives from five of the biggest names in life sciences has concluded that the pressures on international operations are now so great that regulatory outsourcing has become the sensible solution, so that affiliates can focus on commercial priorities.

The event, hosted by ProductLife Group (PLG) brought together senior RA personnel from Merck, LEO Pharma, AbbVie, Sanofi and Lundbeck, to explore companies’ shifting positions on the role of affiliates and the potential of regulatory outsourcing.

Together, they distilled some important best practices as the industry adapts to new operating models, eg:

1. Move key affiliates away from routine transactional activities around regulatory and pharmacovigilance, so they can focus on commercial activities and strategic tasks.
2. Scope and target activities that are particularly time consuming, eg the operational aspects of submission publishing and change control.
3. Quantify the potential benefits of giving this work to someone else, eg: scalable local resourcing and greater scope to target peripheral markets economically
4. Communicate the benefits, to tackle fears head on.
5. Plan and manage the transition well, setting expectations.

The full roundtable debate, Brave New World: Outsourcing and the Changing Role of the Affiliate, is available for download here.

Participants were:

• Regina Freunscht, Vice President, Head of Global Regulatory Affairs Operations, and 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
• Chair: John Farrell, Chief Operating Officer, ProductLife Group

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 productlifegroup.com or follow us on Twitter at @ProductLife_EU

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