Sharing regulatory intelligence: Are newsletters here to ... - TOPRA

8Focus – Regulatory intelligenceIn continuing the momentum of any successfulsocial media strategy, the RI function mustdemonstrate that it is deriving new insightsthat can be leveraged for strategic advantagel Emphasise the return-on-investment (ROI) of social media. Manyapplications are free but the additional intelligence and operatingefficiencies could provide a competitive advantage and reduceopportunity costs at the same time (CSF).l Ensure any initiative is aligned with your organisation’s policy onusing social media.l Pilot a number of social media initiatives within the regulatorydepartment based on the suggested uses above. Incorporatesocial media into formal business processes; for example, usingblogs or discussion boards to gather comments on draft regulatoryauthority guidelines.l Create a number of super-users that can champion the virtues ofsocial media.l Partner with your organisation’s business or IT groups to leveragetheir expertise and align with any similar social media initiativesthey might be implementing.l Create awareness on which tools are available already and mightbe used without major additional investments in technology.l Partner with your organisation’s training group to develop ondemandweb-based training that will educate colleagues on howto use the social media tools, to help overcome any ‘technophobia’they might have.In continuing the momentum of any successful social mediastrategy, the RI function must demonstrate that it is managing thenoise that some social media bring and is deriving new insights thatcan be leveraged for strategic advantage. One or two bad experiences(eg, delivering wrong intelligence or accidentally sharing proprietaryinformation with a competitor) will undo everything.ConclusionsNewsletters are a key deliverable for the RI function and thereis perhaps an expectation among RI and other regulatory affairsprofessionals that they should stay. However, social media haverisen in prominence and clearly have a purpose in a professionalsetting. RI specialists are starting to use social media more andmore in their daily work. Social media cannot replace the minds ofexperienced regulatory professionals when it comes to providinginsight and perspective on the changing regulatory environment;however, they have the potential to enhance the current methodsused to gather, manage and deliver regulatory intelligence tointernal stakeholders.Social media will have a role to play in the future of regulatoryintelligence. The extent of that role will depend on how successfulthe RI function is in demonstrating the strengths and opportunitiesof social media versus their weaknesses and threats (as comparedwith more traditional methods). It will also depend on resources andexpertise within the RI function –RI specialists must become moreknowledgeable themselves and keep up with the latest advances.This means frequent outreach and partnering with IT professionals inthe same organisation.The expectations, preferences and needs of internal stakeholderswill also determine the future of social media. If internal surveysfavour newsletters even after repeated attempts to demonstratethe value of social media, then any further efforts to promote socialmedia may be actively resisted. Of course, one compromise is thatnewsletters and social media unite to form an intelligence ‘mashup’in one space. Some content will be controlled; other content willstream in via embedded social media tools. Indeed, some technologyvendors already offer so-called integrated solutions that allow this tohappen. A mixture of the old and the new may be the answer and willsee both the newsletter and social media play a role in the future ofregulatory intelligence.About EU RING*The Regulatory Intelligence Networking Group (RING) is an industryforum whose creation in 2006 was prompted by the emergence of a newprofession of regulatory intelligence specialists in the pharmaceuticaland biopharmaceutical sectors. RING comprises representatives fromsome of the largest companies in the industry and aims to centralisenon-confidential regulatory information. Its objective is to increasethe efficiency and recognition of regulatory intelligence by sharingprocesses, practices and experience in non-product specific and nonconfidentialareas.The RING comprises the following individuals: Ulrika Assargaard,Head Regulatory Intelligence at Hoffmann La Roche; ElisabethFournier-Qezari, Director Regulatory Intelligence, EU & other regionsat Sanofi-Aventis; Carolyn Hynes, Director Global Regulatory Policy& Intelligence at Janssen R&D; Angelika Joos, Head Regulatory PolicyEurope & RoW at MSD; Marianne Köhne, Head Regulatory IntelligenceOffice at Boehringer Ingelheim; Christine Mayer-Nicolai, Director,Head Global Regulatory Intelligence & European Regulatory Policy atMerck Serono; Helene Orme, Senior Manager Regulatory Policy andIntelligence at Abbott; Elaine Whiting, Associate Director RegulatoryPolicy, Intelligence and Labelling at AstraZeneca; Merete Schmiegelow,Regulatory Director, Regulatory Policies and Intelligence at NovoNordisk; Helene Thybo, Regulatory Professional Regulatory Intelligenceat Leo Pharma; Iain Todd, Manager Safety and Regulatory Intelligenceat Pfizer; Carol Walker, Manager, Regulatory Intelligence and SOPsat Gilead; Birgit Wolf, Regulatory Intelligence Manager EU at BayerPharma AG; Alexa Hunter, Head Regulatory Intelligence at MerzPharmaceuticals.References1 Regulatory Intelligence Networking Group (RING). ‘The CompanyRegulatory Intelligence (RI) Function’, RAJ Pharma, Informa Healthcare, Oct2007, p671-673.2 Kaplan Andreas M, Michael Haenlein (2010). ‘Users of the world, unite! Thechallenges and opportunities of social media’, Business Horizons, 2010; 53(1): pp59–68.3 Ibid.4 Senak M. ‘Eye on FDA’, http://www.eyeonfda.com/ (accessed 15 February2011); Wasserstein J, Kars K, FDA law blog, http://www.fdalawblog.net/,Hyman Phelps, McNamara PC, (accessed 15 February 2011).5 ‘McKinsey global survey results: How Web 2.0 is helping companiescompete’, McKinsey & Company (2010).Regulatory Rapporteur – Vol 8, No 5, May 2011www.topra.org