Fraud Investigation & Dispute Services, Life Sciences team Tighter competition, regulatory scrutiny and tough enforcement heighten the risk of litigation and non-compliance. In your industry, compliance issues and risk factors need to be addressed at every turn from research and development to marketing strategies and supply chain integrity. And the scrutiny of regulators and customers alike is increasing and rapidly changing. Our professionals understand the complex issues facing pharmaceutical, biotechnology and medical device companies. We have significant experience helping companies evaluate and manage those aspects of their businesses that pose the greatest potential risks. Our dedicated team includes CPAs, government contract analysts, economists, licensed pharmacists and certified fraud examiners, as well as former pharmaceutical executives, ethics and compliance officers and government auditors, investigators and prosecutors. For more information visit www.ey.com or contact: Ted Acosta, Principal, Fraud Investigation & Dispute Services (212) 773-3022 or Mariusz Witalis, Partner, Fraud Investigation & Dispute Services +48 22 557 7950.
The Global Pharmaceuticals and Life Sciences Industry Group at PwC is dedicated to delivering effective solutions to the complex business challenges facing pharmaceutical and life sciences companies. A global leader in serving the pharmaceutical and life sciences industry, PwC has extensive experience working with companies on industry-specific strategic, operational, and financial issues. Our capabilities include assurance, tax and advisory services, as well as industry specialised services in regulatory compliance, risk management, and transaction support. In helping our clients, we draw on the full knowledge and skills of PwC's professionals. More than 195,000 people in 157 countries connect their thinking, experience and solutions to build public trust and enhance value for clients and their stakeholders. For more information, visit www.pwc.com/pharma.
IMS Health is a leading global information and technology services company providing clients in the healthcare industry with comprehensive solutions to measure and improve their performance. Drawing on information from 100,000 suppliers, and on insights from more than 55 billion healthcare transactions processed annually, IMS Health's approximately 10,000 employees drive results for healthcare clients globally. Customers include pharmaceutical, consumer health and medical device manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community. IMS Health's industry leading aggregate spend solution, AggregateSpend360, helps pharmaceutical and medical device companies efficiently comply with local, regional and global transparency requirements - such as the Sunshine Act in the US, the Réforme du Médicament in France, disclosure guided by the European Federation of Pharmaceutical Industries and Associations (EFPIA), and anti-bribery regulations such as the UK Bribery Act and Foreign Corrupt Practices Act. It is a pro-active, web-based application that automates and streamlines the tracking and reporting of all expenditures between Life Sciences companies and healthcare professionals. For more information, visit www.IMSHealth.com.
Arnold & Porter LLP, an 800 lawyer firm with offices in the US and Europe, is ideally positioned to serve the needs of the Biopharmaceutical and Medical Device community. Our team of more than 50 regulatory and compliance attorneys advise life sciences companies in developing, implementing and refining global compliance programs that address regulatory and enforcement risks confronted at each stage of product research and development, manufacturing, marketing and distribution. We regularly advise companies in matters raising complex compliance issues, developing practical solutions to the challenges associated with conducting clinical trials in jurisdictions with varying healthcare systems, the complexities and risks of pharmaceutical supply chains, interactions with physician and patient populations, managing co-development and co-promotion arrangements, and outsourcing of functions in areas such as research, pharmacovigilance and manufacturing. We also vigorously defend our clients in a broad range of investigations and enforcement matters. For more information please visit www.arnoldporter.com or contact Daniel A. Kracov, Partner, (202) 942-5120.
Baker & McKenzie's involvement in the pharmaceutical, healthcare and medical industry stretches over 50 years. Our global team of more than 450 lawyers with deep experience in local regulatory processes and laws affecting pharmaceutical, medical device and biotechnology businesses, helps healthcare companies stay ahead in established markets and gain ground in new ones. Baker & McKenzie has a legal network spanning 77 locations in 47 countries. We provide a wide range of healthcare compliance advice and assistance, including in relation to: anticorruption, trade sanctions and export controls, customs, antitrust, data protection, environmental, healthcare marketing and promotional law, as well as transactional due diligence. In the area of global compliance, we provide integrated counsel to ensure consistency across borders and markets. For more information, please visit www.bakermckenzie.com, or contact Jane Hobson, Chair Global Pharmaceutical & Healthcare Industry Group, +44 20 7919 1907.
International law firm Clifford Chance combines the highest global standards with local expertise. Leading lawyers from different backgrounds and nationalities come together as one firm, offering unrivalled depth of legal resources across the key markets of the Americas, Asia Pacific, Europe and the Middle East. Established in the early 1990s, Clifford Chance's Global Healthcare and Life Sciences team consists of more than 140 dedicated lawyers in 36 key centres worldwide. Having cultivated an expertise in the industry over nearly two decades and worked with many of the world's leading pharmaceutical, biotechnology, medical device and health care services companies, we understand the importance of anticipating regulatory and contractual issues in the context of corporate investment, finance, strategy and operations. We have close relations with a number of multi-nationals as well as national and international trade associations in the pharmaceutical and medical device industries. Clifford Chance has 36 offices in 26 countries and over 3400 legal advisors globally. For more information, please visit www.CliffordChance.com or contact Peter Dieners, Partner, Germany, +49 211 4355 5468.
Those of us in the Davis Wright Tremaine health care practice group devote nearly all of our time to industry-specific matters. This allows us to develop niche practices within the field that serve needs unique to the health care market. We also understand the business issues and regulatory developments that affect health care delivery and compliance, and as a unified team we can match the attorney with the niche expertise that best addresses client needs. For more information visit our website at www.DWT.com.
Hogan Lovells is a global legal practice that helps corporations, financial institutions, and governmental entities across the full spectrum of their critical business and legal issues globally and locally. We have over 2,500 lawyers operating out of more than 45 offices in the United States, Europe, Latin America, the Middle East, and Asia. With more than 100 lawyers serving the pharmaceutical and biotechnology sectors, including many with experience at the FDA, CMS and other key agencies and in industry, and others holding advanced degrees in relevant disciplines, we offer timely, effective counsel on matters that include product development, approval and post-approval compliance, and the development of next-generation products. High rankings in Chambers, Legal 500, and other global directories speak to the quality and impact of our services. Whether your products are traditional drugs or biotechnology products, we work with you to successfully develop and commercialize products, addressing issues of regulatory approvals and compliance; coverage, reimbursement, and pricing; and careful use of intellectual property and regulatory exclusivities to manage product life cycles. Our multidisciplinary team leverages the skills and experience of colleagues in other disciplines - including healthcare compliance (such as coverage, reimbursement, pricing, and fraud and abuse prevention), public policy, intellectual property, corporate and securities law, and litigation - to provide integrated, strategic, and practical advice for successful product development and marketing and effective responses to regulators and competitors. For more information, visit www.hoganlovells.com.
Celebrating more than 125 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 800 lawyers in 17 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, for uncompromising commitment to quality and for dedication to understanding the business and culture of its clients. In 2013, King & Spalding was chosen by U.S. News & World Report and Best Lawyers as the "Law Firm of the Year" for FDA law and ten King & Spalding lawyers were identified as 'life sciences stars' in the 2013 edition of LMG Life Sciences. For more information about our FDA & Life Sciences practice, please visit www.kslaw.com or contact Mark Brown at (202) 626-5443.
Paul Hastings provides innovative compliance and legal solutions to many of the world's top pharmaceutical and life sciences companies of all sizes in markets across Asia, Europe, Latin America, and the United States. We offer a complete portfolio of services to support our clients' complex, often mission-critical needs--from structuring first-of-their-kind transactions, to protecting critical intellectual property, to resolving complicated global anti-corruption enforcement matters, to providing the savvy compliance and legal counsel that keeps business moving forward. We have a global network of professionals to support our clients' ambitions, and have a significant and strategic presence across Europe, and were one of the first U.S. law firms to establish a presence in Asia. Over the past decade, we have significantly expanded our global network of lawyers to assist our clients in financial centers around the world, including the emerging markets of Latin America, where we recently opened our new office in Sao Paolo. For more information visit www.PaulHastings.com or contact Nathaniel Edmonds at 202-551-1700 or Gary Giampetruzzi at 212-318-6000.
Polaris is the only company in the world that specializes exclusively in consulting and technology solutions for life sciences healthcare law compliance. We are at the forefront of the industry in terms of delivering insights and defining technology standards through innovation fueled by our "what's next" entrepreneurial culture. Through collaboration and dedication, we apply our No Matter What accountability to every customer engagement to increase efficiencies, mitigate risk, and improve patient safety through compliance. We deliver on our customer's goals and place their successes ahead of our own. For more information visit www.polarismanagement.com or contact our Amsterdam office at +184.108.40.2068.
Porzio Life Sciences, LLC (PorzioLS) provides the life sciences industry with Internet-based products enabling companies to comply with marketing and sales federal and state laws and regulations, as well as, distribution licensing, sampling and a growing body of state life science compliance requirements. PorzioLS provides compliance tools and customized services, related to the PDMA, anti-kickback statutes, aggregate spend reporting, OIG and CMS guidances, OPDP promotional violations, False Claims Act and FDA regulations, such as Porzio AggregateSpendID®, a best in class aggregate spend system capable of handling state and federal transparency reporting and dispute resolutions, in addition to sample transparency reporting. Porzio AggregateSpendID streamlines state and federal marketing disclosures by automating the collection and accurate reporting of expenses directed to healthcare practitioners and organizations. The searchable databases of the Porzio Compliance Digest cover drug and device distribution licensing, transparency legislation, sample and trade product distribution, and trends in government investigations. Our Global Commercialization services provide clear, data driven yet practical guidance on how to best enter and maximize a domestic, European or foreign market, whether it be via traditional partnering or organic development of our innovative commercialization platform. We offer a powerful resource network, proven launch plans and clear executable strategies for entering a diverse marketplace with a multitude of different countries, governments, languages, customs and commercial requirements. The International Life Sciences Transparency Database contains invaluable guidance on ex-US disclosure obligations pertaining to HCP, HCO and PO payments and provides information on laws and codes related to the following: transparency reporting requirements, limitations or prohibitions on financial interactions with healthcare providers and organizations, anti-bribery or anti-corruption, data privacy, and company compliance programs related to interactions with healthcare providers. Porzio GST™ is a Provider Management Simplified solution, focused on Global Spend Transparency, with an easy-to-use and configurable interface that enables companies to capture and manage the data elements that are necessary for meeting their reporting obligations in ex-US countries. Strengthen your compliance program today by visiting www.porziolifesciences.com or contacting us 877-477-7411.
Sidley Austin LLP is a premier law firms with an internationally recognized life sciences practice, representing large to start-ups pharmaceutical, biotechnology, medical device, dietary supplements and food clients. Many lawyers in our team are acknowledged leaders in regulatory, compliance and enforcement. Sidley consistently ranks among the top firms in Asia, Europe and the U.S. Sidley won "Life Sciences Firm of the Year" at The Asian Lawyer's 2014 All-Star Firm Award and was named "Firm of the Year" by Asian-MENA Counsel for Life Sciences in China. At the inaugural LMG Life Sciences Awards in 2014, Sidley won "Regulatory Firm of the Year" and "Europe Regulatory Firm of the Year". We also received first-tier national rankings in Biotechnology Law, FDA Law and Healthcare Law in the U.S. News -- Best Lawyers "Best Law Firms" rankings for the fifth consecutive year, and each year since the survey's inception. Also, Sidley is recognized for service and responsiveness, having been once named the "Most Recommended Law Firm in the Pharmaceutical Industry" in the BTI Industry Power Rankings. For more information visit www.Sidley.com or contact Scott Bass, (202) 736-8684, James Stansel, (202) 736-8092, and Maurits Lugard, +32.2.504.64.17.
With approximately 1,700 attorneys in 23 offices on five continents, Skadden represents a broad range of clients in all sectors of the health care industry. We advise pharmaceutical and medical technology clients across the areas of transactions, government regulation and investigation, and litigation. Our work has included multibillion-dollar mergers, complex licensing transactions, product liability defenses, intellectual property matters, and regulatory and enforcement challenges. Skadden has assisted many companies in developing and implementing global anti-bribery and anti-corruption compliance programs, and represented numerous companies in related government investigations. For more information visit www.Skadden.com.