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GRANTORS & EXHIBITORS
We thank the following Grantors and Exhibitors for their support in helping to make this conference possible.
GRANTORS
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DIAMOND
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Ernst & Young
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.
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PLATINUM
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PricewaterhouseCoopers (PwC)
PwC's Pharmaceutical and Life Sciences Industry Group is dedicated to delivering effective solutions to the complex strategic, operational and financial challenges facing pharmaceutical, biotechnology and medical device companies. We provide industry-focused assurance, tax and advisory services to build public trust and enhance value for our clients and their stakeholders. More than 180,000 people in 158 countries across our network share their thinking, experience and solutions to develop fresh perspectives and practical advice. For more information visit www.pwc.com/pharma and www.pwc.com/medtech or contact Marina Bello Valcarce, +44 207 212 8642.
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GOLD
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Cegedim Relationship Management
Cegedim Relationship Management is the Life Sciences industry's leading global provider of Customer Relationship Management (CRM) and Regulatory Compliance solutions. Given the recent enactment of diverse compliance and disclosure and transparency regulations across every global market, the pharmaceutical industry is focused on mitigating fines, reputational risks and possible court cases associated with bribery and corruption. However, achieving regulatory compliance and meeting disclosure and transparency requirements can be a complex and costly challenge.
AggregateSpend360, Cegedim Relationship Management's pro-active, web-based application, automates and streamlines the tracking and reporting of all expenditures between Life Sciences companies and healthcare professionals per local, regional and global transparency requirements -- such as the US Patient Protection and Affordable Care Act (frequently referred to as the Sunshine Act) -- and anti-bribery regulations such as the UK Bribery Act and Foreign Corrupt Practices Act. This process can be leveraged by accurate customer data management and the integration of a wide range of enterprise applications -- CRM, ERP, Finance, Travel & Expense and HR -- for in-depth analysis and improved insight. For more information visit www.cegedim.com/rm.
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Deloitte
The mission of Deloitte's Health Care and Life Sciences practice is to work with our clients -- life sciences companies, health plans and health care providers -- to help shape the new health economy and the roles they play within it. Working together, we can help our clients in their efforts to bring discoveries to life and improve the quality of care while achieving their business goals and objectives. Drawing on more than 70 years of Life Sciences experience, with the innovation, knowledge, and commitment of more than 3,300 professionals focused on the industry, we have access to a full range of audit, tax, consulting, and financial advisory services across all sectors of the industry. We offer wide-ranging, customized services and solutions designed to help our clients in their efforts to capitalize on opportunities and tackle their most pressing and complex challenges. For more information, contact Yogesh Bahl at +1 212 436 6942.
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SILVER
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KPMG
With deep industry experience, insight, and technical knowledge, the KPMG Global Life Sciences Practice is one of the largest providers of audit, tax, and advisory services to pharmaceutical and life sciences companies. We help clients gain practical insight into emerging issues, consider approaches to balance risk and controls, improve performance, and explore the accelerating transformation of this industry, both domestically and globally. For more information about the KPMG Global Life Sciences practice, please visit us at www.kpmg.com.
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BRONZE
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Advanced Health Media (AHM)
AHM is the leading global provider of technology-enabled services designed to manage compliant interactions with healthcare professionals (HCPs). Our patented systems used by tens of thousands of industry sales representatives, managers and healthcare professionals worldwide. For more information visit www.ahmdirect.com or contact Wayne Baker, Sr. Vice President & Chief Sales Officer, (908) 393-8820.
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Arnold & Porter
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 global 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.
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Baker & McKenzie
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 72 locations in 45 countries. The pharmaceutical, healthcare and medical device industry group has a strong understanding of the changing regulations regarding product registration, market access, trade promotion, product liability, labeling and advertising restrictions, compliance and anticorruption and other issues that affect market players in the US and around the world.
For more information, please visit www.bakermckenzie.com, or contact Michael Wagner, Chair Global Pharmaceuticals & Healthcare Industry Group, +1 312 861 2965, or Jane Hobson, Chair EMEA Pharmaceuticals & Healthcare Industry Group, +44 (0)20 7919 1907.
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Clifford Chance
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 100 dedicated lawyers in 34 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 35 offices in 25* countries and over 3400 legal advisors globally. (*The Firm also has a co-operation agreement with Al-Jadaan & Partners Law Firm in Riyadh.)
For more information, please visit www.CliffordChance.com or contact Peter Dieners, Partner, Germany, +49 211 4355 5468.
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Davis Wright Tremaine
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.
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Hogan Lovells
Hogan Lovells provides high quality advice to corporations, financial institutions, and governmental entities across the full spectrum of their critical business and legal issues globally and locally. Bringing together the combined strengths of our predecessor firms, we have more than 2,500 lawyers operating out of more than 40 offices in the United States, Latin America, Europe, 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, PLC Which Lawyer?, 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 or contact Marketing Manager Julie Merkin at +1 202 637 6830.
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King & Spalding
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, uncompromising commitment to quality and dedication to understanding the business and culture of its clients. For more information about our FDA & Life Sciences practice, please visit www.kslaw.com.
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Polaris
Polaris is a management consulting firm focused exclusively on the compliance needs of the life sciences industry. Polaris offers a suite of services that specifically target the compliance risks confronting the life sciences industries, including: compliance risk assessments, auditing and monitoring, policy and SOP development, strategic and operational solutions, aggregate spend services. In addition, Polaris Solutions has developed automated business process workflows which address medical education grants, investigator initiated trials, interactions with HCPs, exhibits, sponsorships and aggregate spend. For more information visit www.PolarisManagement.com or contact Andy Bender, President, (212) 502-1872.
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Porzio Pharmaceutical Services
Porzio Life Sciences, LLC (PorzioLS) provides the life science 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, False Claims Act and FDA regulations, such as the Porzio Compliance Digest and Porzio AggregateSpendID, a best in class aggregate spend system capable of handling state and federal transparency reporting, 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 licensing and distribution, transparency legislation, sample and trade product distribution, and trends in government investigations. Through our Licensing & Distribution Services, we identify and attain all required licenses based on a company’s unique distribution model. Finally, our formula-based approach to sample accountability, Significant Loss Threshold Assurance, ensures that customers neither over or under report sample losses. These compliance tools and customized services facilitate companies’ compliance with federal and state marketing and sales regulations, which has propelled PorzioLS into an industry leader in life science marketing and sales compliance. Strengthen your compliance program today by visiting www.porziolifesciences.com or contacting us 877-477-7411.
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Sidley Austin
Sidley Austin LLP is one of the world's premier law firms with an internationally recognized life sciences practice, representing major pharmaceutical, biotechnology, medical device, diagnostics, dietary supplements and food clients. Many lawyers in our team are acknowledged leaders in their field. Sidley consistently ranks among the top firms in Europe, Asia and the U.S., including by Chambers and Partners and PLC Cross-border Life Sciences Handbook, both of which highlight the firm for its leadership in life sciences regulatory and compliance, government enforcement and investigation, products liability, corporate, intellectual property and antitrust matters. And Sidley is the only firm to be recognized on three continents for its leading life science practices by PLC in 2012.
For more information visit www.Sidley.com or contact Maurits Lugard, 32.2.504.6417; Scott Bass, 1.212.839.5613 or James Stansel, 1.202.736.8092.
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ADDITIONAL
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Thomson Reuters Accelus
Thomson Reuters Governance, Risk and Compliance (GRC) business unit provides comprehensive solutions that connect our customers' business to the ever-changing regulatory environment. GRC serves audit, compliance, finance, legal, and risk professionals in financial services, law firms, insurance, and other industries impacted by regulatory change.
The Accelus suite of products provides powerful tools and information that enable proactive insights, dynamic connections, and informed choices that drive overall business performance. Accelus is the combination of the market-leading solutions provided by the heritage businesses of Avanon®, Complinet, IntegraScreen, Northland Solutions, Oden®, Paisley®, West's Capitol Watch®, Westlaw® Business, Westlaw Compliance Advisor® and World-Check®.
For more information, visit http://accelus.thomsonreuters.com/ or call +44 (0)870 042 6410.
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EXHIBITORS
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Center for Health & Pharmaceutical Law & Policy
Seton Hall Law's Center for Health & Pharmaceutical Law & Policy advances scholarship and recommendations for policy on the varied and complex issues posed by health and pharmaceutical law. As a nationally ranked Health Law program, the Center fosters informed dialogue between policymakers, consumer advocates, the medical profession, and industry in the search for solutions to the ethical, legal and social questions presented in the health and pharmaceutical arena.
In addition, the Center is a leader in providing healthcare compliance education and training in the U.S., and Europe and Asia on national and international mandates that apply to the safety and promotion of drugs and devices. The Center also hosts conferences and educational programs, inviting leading experts from the public and private sectors to examine cutting edge policy issues.
Launched in April 2007, the Center extends Seton Hall Law School's national reputation in health law to the life sciences arena and offers a challenging health law curriculum through its M.S.J., J.D. and LL.M. degree programs and online Graduate Certificates. The Center operates under the leadership of a full-time Executive Director, Simone Handler-Hutchinson, and draws upon the intellectual strength of the Seton Hall Law School faculty and research fellows who bring to the Center's work nationally recognized expertise in health and pharmaceutical law, not-for-profit governance, intellectual property law and bioethics, among other areas.
For further information or inquiries about the Center and its varied programs, please visit the website at law.shu.edu/CenterforHealth and law.shu.edu/compliance, or contact Simone Handler-Hutchinson, Executive Director of the Center.
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TeamMate
In an industry where the products being manufactured and sold impact the safety and health of people around the world, it is no wonder that the public and regulatory pressures facing organisations like yours are greater than most. TeamMate CM is the compliance management software you have been waiting for to address pharmaceutical compliance standards. The highly flexible design and dynamic working view allow for quick access to relevant data and for performing multiple activities from a single screen. TeamMate CM is an enterprise compliance management system designed to help you develop, organise, execute, and track your compliance requirements more effectively, efficiently and holistically.
Designed and developed with extensive input from compliance experts, TeamMate CM can be used as a hosted stand-alone solution or seamlessly integrated with the award winning and audit industry standard TeamMate Audit Management System.
For more information visit www.teammatesolutions.com/CM or call +44 20 7981 0566.
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Interested in becoming a Grantor or Exhibiting?
Click Here for more information or contact Justin Sorensen at 206-452-0609.
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