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

6Focus – Regulatory intelligenceNetworking sites allow individuals to tap intothe combined wisdom of other regulatoryprofessionals – questions and answers can beexchanged in real time rather than waiting forthe outcome of a formal consultation processprocess doesn’t allow large numbers of people to share their opinionor experiences. The construction of the newsletter can also becumbersome, with more time spent on formatting the articles in thenewsletter template than writing the articles themselves.With some of the limitations of newsletters in mind, a secondsurvey was circulated to the RING member companies in mid-2010. The purpose of this survey was to establish what novel tools/approaches were being considered that could enhance the deliveryof RI, including automating the process for creating electronicnewsletters. Unsurprisingly, many of the tools under consideration fellunder the category of social media.Social media – a new approachOrganisations and institutions of all sizes are embracing socialmedia - their power, impact and value becoming more apparent inthe last few years. Social media have enabled real-time reporting ofpolitical demonstrations and provided platforms for viral marketingcampaigns that reach global audiences in a matter of seconds.Put simply, social media enable social interaction and informationexchange on the internet. They are, according to Kaplan and Haenlein,“internet applications that build on the ideological and technologicalfoundations of Web 2.0”. 2Whereas Web 1.0 was about accessing static, prescribed content,Web 2.0 is about creating dynamic, user-generated content, theimportance of which is determined by the “crowd”.According to Kaplan and Haenlein, there are six different types ofsocial media:l Collaborative projects, eg, Wikipedia (collaborative authoring)l Blogs and microblogs, eg, Twitterl Content communities, eg, Delicious (social bookmarking)l Social networking sites, eg, FaceBookl Virtual game worldsl Virtual communities, 3 eg, YouTube (video-sharing community).How are social media utilised by RI specialists today?Blogs: These are fast becoming the medium of choice for amateurs andexperts alike to share their opinions on a particular subject matter. Short for‘weblog’, blogs are, in essence, on-line diaries; collectively, they are knownas the ‘blogosphere’. The blog is an excellent vehicle for RI specialistsand other professionals in regulatory affairs to share their insights andexperiences on the changing regulatory environment. There are a numberof regulatory-orientated blogs on the web: Eye on FDA and the FDA law blogare a couple of good examples – both authored by experts. 4Frequently, blogs are accompanied by discussion boards andcommenting facilities. These allow readers to add their experiencesand to challenge the thoughts from others in order to create arich stream of intelligence that can be easily shared with others. Inthat regard, the blog offers an easy way to extract tacit regulatoryknowledge (unpublished know-how) from the minds of colleagueswhere it might otherwise stay, reducing the need for lengthy faceto-faceinterviews. Blogs might also provide a useful vehicle forgathering comments on draft regulatory authority guidelines orfeedback on health authority initiatives.Microblogs: These allow users to post short statements (usually 140characters) for others to view and comment on. Twitter is probablythe most well-known microblog site – a site that allows users tofollow a multitude of microbloggers, although there are others, suchas Tumblr and Plurk, with similar functionality.Twitter has a number of pharma/regulatory affairs-orientatedmicroblogs that individuals can follow (eg, Tim Felgate, EFPIA,PharmaFocus and Pharma IQ). These microblogs provide acontinuous stream of pharma and regulatory news and providean alternative way to be alerted to the presence of newly releasedregulatory authority documents.One potential application of microblogs for the RI specialist is touse them as a tool to provide real-time reporting of presentationsbeing delivered at conferences – presentations that might containuseful intelligence (eg, release dates of important new guidelines oreagerly anticipated regulator initiatives). Due to their one-to-manydissemination feature, microblogs allow any number of internalstakeholders to follow the posts of their RI colleagues and commentas necessary. In that regard, microblogs make a useful alternative tolengthy email chains that can only be viewed by a limited number ofpeople at any one time.Wikis: Most people have heard of Wikipedia – the web-basedencyclopaedia to which anyone can contribute. The ‘wiki’ (theHawaiian word for quick) offers a collaborative space for multipleauthors to create online documents that can be viewed and editedby any number of stakeholders. There are several applications ofwikis for RI specialists, for example to create briefing documentson specific regulatory topics or for an encyclopaedia of regulatoryterms. These documents can be accessible to everyone within anorganisation (ie, displayed on an RI intranet site) and can be usefulquick references for senior management, new starters or nonregulatoryaffairs professionals to facilitate their understanding ofkey regulatory issues.Social/professional networking: Social networking platforms suchas FaceBook, MySpace and Bebo are seen as the sole preserve oftech-savvy teenagers. For professionals who do not see these tools asserious applications but want to connect with one another, there arethe more ‘grown-up’ professional networking sites such as LinkedInand Ryze. LinkedIn also has a number of special interest groups specificto regulatory affairs that individuals can join (by application) – forexample, TOPRA and ‘Reg-Info’. These interest groups are being used toexchange intelligence and advice on regulatory matters. In that respect,LinkedIn offers a faster alternative to trade associations when it comesto garnering industry experience on a particular regulatory issue ortapping into the combined wisdom of other regulatory professionals.Questions and answers can be exchanged in real time rather thanwaiting for the outcome of a formal consultation process.If data are mined appropriately (ie, within the terms of the useragreements and privacy policies), these professional networking sitescould also facilitate key opinion leader (KOL) mapping exercises andprofessional profiling requests.Regulatory Rapporteur – Vol 8, No 5, May 2011www.topra.org

Focus – Regulatory intelligence7For RI specialists whose company establishes their own internalnetworking platform, one application could be to use it to identifyinternal subject matter experts when seeking comments coordinatorsfor draft regulatory authority document reviews.RSS, news aggregators and tagging: RSS (Really SimpleSyndication) and news aggregators enable RI specialists to automatethe gathering of online content from a multitude of regulatorywebsites (assuming they are RSS-enabled) and view them in oneplace.The US FDA and EMA websites are now RSS-enabled, as are somenational competent authority sites. The intelligence-gathering netcan be cast much wider and use of aggregation tools can releasethe time used by RI specialists in manually checking each and everywebsite for updates – time that can be better spent on providinganalysis and perspective. The downside is that no ‘human filter’ isapplied to the information gathered, and thus the news feed couldbe full of ‘irrelevant noise’.Tagging and ‘tag clouds’ are replacing traditional folderstructures in electronic document repositories, expediting storageand retrieval and thereby facilitating access to key regulatoryintelligence material. For example, meeting minutes from aconference can be uploaded and tagged (tags are single wordsthat capture the subject matter of the document, like the keywordsabove) and then retrieved quickly by clicking on those same tags inthe tag cloud (rather than having to search through multiple layersof folders). As tags get re-used, so they alter in size (and sometimescolour) allowing the reader to quickly see which topics are the mostpopular or frequently cited.Is social media the future of regulatory intelligence?The RING’s opinion is that social media will have a role; however, theextent of that role is not yet clear. At least two of the following thingsmust happen: firstly, the strengths and opportunities of social media(in a regulatory setting) must outweigh the weaknesses and thethreats, particularly as benchmarked against traditional approachessuch as the newsletter; secondly, the RI function must be preparedto proactively demonstrate the value of social media to internalcustomers and industry peers via a well-planned and carefullyimplemented engagement strategy, and to persevere with thisstrategy if there is resistance the first time around. The success of eachof those elements will determine the extent to which social mediawill play a role in the future delivery of regulatory intelligence, ie,more success equals a greater role. The second RING member surveyrevealed relatively low uptake of social media in both the RI functionsand the RING member organisations in general, so there is still muchwork to be done.Strengths and opportunitiesSocial media have the potential to expedite or improve thegathering, dissemination and storing of regulatory intelligence. RSSand news aggregators automate the gathering process and allowmore sources to be tracked at the same time. Social media removebarriers to participation, effectively allowing online conferencesto take place with a much wider degree of audience participation.They also enable the sharing of tacit knowledge, something thatknowledge management strategies frequently fail to accomplish. Inshort, social media improve operational efficiency and provide newsources of intelligence.Weaknesses and threatsThe second RING member survey revealed that technology platformsincorporating social media are not being taken up, predominantly dueto budget constraints and the limitations of the technology. However,there is also a cultural element that drives resistance to social media,despite the advantages mentioned above.Regulatory affairs professionals are busy people. Commenting on anRI colleague’s blog post or following a real-time report via a microblogtakes up precious time. The attitude is that these activities divertattention away from ‘business-critical’ activities. The appropriatenessof social media in the regulatory setting is also questioned. There isthe fear that an off-the-cuff remark typical of a social media exchangewill be circulated quickly and read by many, with retaliation followingswiftly if reputations are damaged. Unfortunately, some of the mostuseful regulatory intelligence – perhaps that concerning specificindividuals – cannot be written down, as it may have legal ramifications.These concerns and threats are legitimate but they can be avoided withcareful use. A ‘Best Practice Guide’ or policy, with specific examples,can help colleagues use social media responsibly in the workplace andavoid some of the threats mentioned above. These policies are usuallyapplied at the organisation level and are not specific to regulatory.How can the RI function demonstrate the value of socialmedia to its organisation?In a recent report, the management consultants McKinsey & Conoted: “The most intensive users of Web 2.0 [and by implicationsocial media] are enjoying the biggest growth in market share. Manyexecutives also see a positive impact on information sharing withintheir organisations.” 5 Clearly, industry is recognising the value of socialmedia and RI specialists should build on that momentum.There are a number of strategies and tactics that could be used todemonstrate the value of social media to colleagues and industry peers.As with most strategies, a successful outcome will turn on a few criticalsuccess factors (CSFs) and efforts should be focused on achieving these.In short, a successful outcome will see any cultural resistance to socialmedia fall with a concomitant rise in user uptake and participation. Theformer is difficult to measure (base-lining can be done through peerto-peersurveys); however, the latter can be measured and makes for auseful success metric. Some strategies and tactics include:l Develop and implement an effective communications strategyto promote the use and added value of social media within aregulatory context. Seminars or ‘road show’ type events might bethe best vehicle to do this.l Highlight examples where social media yielded vital intelligence(not likely to be captured by other means) that influenced strategicdecision-making (CSF).l Allay colleagues’ fears over appropriateness or retaliation bydemonstrating how potential threats can be avoided. Developgood practice guidelines to facilitate this threat management.l Dispel colleagues’ notions of ‘time-wasting’ by demonstratinghow participation is quick and easy and can encourage others tocontribute with positive results.l Get senior management buy-in. If the CEO or the head ofregulatory affairs blogs or ‘tweets’ or is shown to be supportiveand actively engaged in your social media strategy, so others lowerdown the organisation will likely participate. An organisationwide(and funded) social media initiative is also more likely to beimplemented, on which the RI specialist can ‘piggy-back’.www.topra.org Regulatory Rapporteur – Vol 8, No 5, May 2011

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