Complex and far-ranging regulations in a fluid environment are becoming increasingly challenging for life sciences companies across Europe. Polaris Europe office head Geert Van Gansewinkel and his team have been addressing the cultural change, process and technology issues with European life sciences companies that are causing the greatest concerns about meeting the mix of transparency laws and codes across the continent and within countries.
The European office of Polaris, a global life sciences compliance consulting firm, has been successfully helping European and global life sciences companies in addressing the range of emerging issues around the complex regulatory environment for life sciences companies.
“Our presence in Europe demonstrates our commitment to help guide life sciences companies globally who are grappling with business-impacting challenges across compliance and transparency…”
Polaris’ European office in Amsterdam is being led by former BCG and Accenture senior business and IT transformation executive, Geert van Gansewinkel. Van Gansewinkel is directing Polaris’ business growth strategy throughout EMEA where life sciences, biopharmaceutical and medical device companies are being impacted by a myriad of regulatory, compliance and business transparency mandates and guidelines. Challenges include the recently developed EFPIA code, country-specific laws governing healthcare provider transparency, clinical data release rules, EU pharmacovigilance and data privacy protection legislation, and FCPA (see presentation, Making Transparency Work).
“Life sciences organizations throughout the EMEA region face mounting operational and technology system challenges from an increasingly stricter regulatory environment that mirror some of the same changes taking place in the U.S. but, at the same time, are also very specific to this region”, explained Van Gansewinkel, Polaris Managing Director Europe. “We understand those differences and are working with the region’s life sciences companies to help them make the successful internal transitions necessary for meeting the growing number of compliance and transparency regulations,” says Van Gansewinkel. “Furthermore, Europe has additional challenges for getting buy in from the local teams, so we are working with organizations from a project and change management perspective to successfully implement adjustments in internal cultures to respond to regulatory developments, Van Gansewinkel continues.
With our international teams speaking 17 different languages on the ground across Europe, Polaris offers life sciences organizations specialized consulting and technology solutions in areas that address compliance, risk assessment, transparency reporting, healthcare professional engagement strategies and monitoring, contracted third-party research monitoring and valuation of promotional and marketing related transactions to healthcare providers.
“Our presence in Europe demonstrates our commitment to help guide life sciences companies globally who are grappling with business-impacting challenges across compliance and transparency, “ explains Andy Bender, President of Polaris. “Our deep background helps organizations not only meet such challenges but actually leverage them to enhance business performance, positioning us as a value-added resource for our clients”, Bender adds.
If you are a member of the media and would like schedule an interview with Mr. Van Gansewinkel, please contact Tony Riggio at +1 646.599.8593 ext. 168 or firstname.lastname@example.org.
For more information about our European products and service offerings or to schedule a consultation appointment please contact Geert van Gansewinkel Gvgansewinkel@polarismanagement.com at + 31 6 508 407 81.