内部监管事务

HBW Insight spotlights regulatory affairs specialists in the consumerhealth and cosmetics industries. Discover what their roles entail, atypical day’s challenges, and what’s top of mind for them. Foreword Change and complexity define the role of regulatory affairs specialists within the consumer healthcare and cosmetics industries, according to the interviews collected here in this HBW Insight ‘InsideRegulatory Affairs’ ebook. In general, we are seeing increased regulation in two of the biggest global markets, the US andin Europe, driven in large part by an expectation that industry should take more responsibility inlooking after the planet, as well as the health and well-being of its inhabitants. Multiple regulations proceeding from the EU Green Deal, for example, ask companies to ensure thatproducts are not just safe to use, but also to dispose of and, if possible, reuse. While they can be anxiety-producing, these changing demands also stimulate creativity and newways of thinking and feed the hunger for new challenges that seem to characterize the profession. As well as a love of learning, the ability to collaborate with internal teams and external stakeholders,including regulatory authorities, is crucial to the success of today’s regulatory professionals. Tradeassociations provide an essential bridge between worlds, our interviews show. We hope you find value in this series highlighting an increasingly vital and, we think, under-celebrated role in consumer health and cosmetics organizations and one that HBW Insight aims toserve consistently with our news and analysis. Look for future series at HBW Insight providing insight into key topics and trends of importance toour audience and, if you haven’t already, subscribe today. AdverCheck’s Lucy Rochford and James Walmsley05AESGP’s Christelle Anquez-Traxler and Oliver Hartmann08AHPA’s Robert Marriott11Bayer Consumer Health’s Jenny Holmes13CHPA’s Mike Bailey, Marcia Howard, and Jay Sirois17EcoMundo’s Morgane Mondon20e.l.f. Beauty’s Gary Peiffer and Meredith Spencer22Haleon’s Niels Kildemark25The Honest Company’s Sharee Crumbey and Monica Sharda28Honey Pot Company’s Kristini Miles32Kenvue’s Kevin Whelan35Olyos Group’s Jean-Noël Perin37 ‘Inside Regulatory Affairs’ withAdverCheck’s Lucy Rochford andJames Walmsley By HBW Insight Team, Nancy Pham In this installment of HBW Insight’s “Inside Regulatory Affairs”series, AdverCheck managing directors Lucy Rochford andJames Walmsley describe how the consumer health industry isincreasingly outsourcing its advertising copy review as it movescloser to the fast-moving consumer goods sector. They alsopoint to a worrying trend in the UK of advertising prescription-only medicines online. Executive Summary Making sure that medicines advertising followsthe rules of a particular market is an art that ifdone poorly, can be costly both financially andin terms of a company’s reputation. This is an art that is being increasinglyoutsourced as the consumer health industrymoves closer to the fast-moving consumergoods sector, reveal Lucy Rochford and James ‘Inside Regulatory Affairs’ with AdverCheck’sLucy Rochford and James Walmsley to review copy promptly and to a highstandard. We encourage clients to see copyreview as an enabling function — involvingus early during campaign developmentmeans that potential barriers can beanticipated and addressed. Our expertise indata interpretation also means we can helpcompanies develop new product claims. Walmsley in this latest instalment of HBWInsight’s Inside Regulatory Affairs. As an outsourced copy review specialist,Rochford and Walmsley’s “fairly new” companyAdverCheck has benefited from this change. Based on their experience, they advocatefor keeping the copy review process “simple,clearly defining roles and responsibilities, anddeveloping basic guidelines and checklists.” Q:How has this role changed over time?A:AdverCheck is still a fairly new company, but we’re already trying to evolve to providethe types of services our clients need. Westarted AdverCheck because we saw anunmet need for an outsourced copy reviewprovider specializing in consumer healthcare.There has been an increasing trend towardsoutsourcing copy review in the pharmasector, and we’re seeing a similar need inconsumer healthcare companies. Regulatoryand medical affairs departments are oftenunder-resourced and increasingly expectedto focus on growth rather than day-to-day activities. We are also seeing internalresources further squeezed in companieswho have made the transition from pharmadivisions to standalone consumer healthcarecompanies, where the resourcing benchmarkis the FMGC [fast-moving consumer goods]sector. However, they point to a worrying trendof advertising prescription-only medicines(POMs) online. Aside from being illegal in theUK, Rochford and Walmsley note concernssurrounding the “lack of online prescriberoversight.” Given that in many categories consumers “nowhave a direct choice between