GHP July 2016

10 | ghp July 2016 Regulatory Mechanics Should Be Outsourced & Affiliate Roles Redefined, Say 6 Senior Executives at the Frontline of Regulatory Affairs 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, such as: 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, such as the operational aspects of submission publishing and change control; 3. Quantify the potential benefits of giving this work to someone else, such as 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 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; news