The medical technology industry is a critical component of the world's health sector—providing rapidly developing technologies to help patients live longer and healthier lives. This global industry is fueled by intense competition and the innovative energy of large multinational firms as well as smaller emerging firms that together drive very rapid innovation cycles among products. The innovative nature of medical device research and development; on-going collaboration with health care professionals having the critical field experience and expertise that guides the industry in creating new advanced technologies; rapid firm growth trajectory and increasingly complex global reimbursement and regulatory environment create unique legal and enforcement risks, compliance rules and industry codes of conduct.
Developed by industry compliance experts, for industry, and based on the latest and emerging trends in global medical technology compliance, the First International Device Compliance Congress is the only medical technology compliance conference for global compliance executives and professionals, global device executives, business leaders, international policymakers, and other industry stakeholders from around the world.
The International Device Compliance Congress offers a collaborative forum for the development of best practices in global device industry compliance programs. The Congress brings together global device industry regulators, compliance professionals, legal counsel, senior executives and industry observers to analyze the major global compliance challenges of the day and to discuss approaches to practical and effective compliance. The Congress provides a comparative analysis of national and international compliance and enforcement trends and serves as a global forum where companies can share their approaches to the development and implementation of effective multi-jurisdictional compliance programs. The Congress will feature a number of unique learning exercises, including panels of compliance experts, leading global medical device association executives, and former and current government officials and leaders in the compliance field. The Congress faculty and sessions reflect a balance of global perspectives, as diverse as the industry itself.
The agenda includes preconference sessions on:
- Comparing, Contrasting and Complying with the Various Medical Device Global Codes of Conduct
- "Dawn Raids" and Applicable Procedure in the EU, Including Preparation, Response and Privilege Issues
Keynote Presentations and Facilitated Discussions:
The Congress will feature Keynote Presentations by Global Compliance leaders, and Features Facilitated Interactive Sessions on:
Networking Reception and Company Best Practices Posted Board Presentations:
- Trends in Global Device Association Codes of Conduct by the Leading Global Medical Device Trade Associations
- The New Italian and French Compliance laws
- Globalization of Fair Market Value
- Managing Global Risk in Third Party Relationships and Distributor Management
- Effective Auditing and Monitoring Across Multi Country Operations
- Managing Compliance Investigations and Compliance Programs in Connection with Corporate Transactions
- Implementing an Effective Global Anti-Bribery Program
- Compliance Training Strategies in a Global Setting
- The New European Regulatory Landscape Governing Device Vigilance and Novel Combination Products
- Managing Investigations and Compliance Programs in Connection with Corporate Transactions
- Counterfeit, Grey Markets and Diversion Issues
- Emerging Compliance Issues in the Pacific Rim
The Congress will feature a unique networking reception opportunity - a Tuesday evening reception featuring a company Best Practice Policy and Procedure Poster Board and Exchange to encourage best practices exchange.
WHO SHOULD ATTEND
From Medical Device Firms:
- Presidents and Executive Teams
- Compliance Officers
- Quality and Regulatory Officials
- Ethics Officers
- Quality Engineers
- Legal Counsel
- Marketing Officials
- Financial Officials
- Reimbursement Officials
- Privacy Officers
- Corporate Social Responsibility Personnel
- Promotion Signatories/Approvers
- Risk Management Personnel
THE CONGRESS GOALS AND OBJECTIVES
- Government Officials
- Regulators and Policy Makers
- Other Health Care Professionals
- Lawyers in Private Practice
- Health Services Researchers
INTERNATIONAL DEVICE CONGRESS PLANNING COMMITTEE
- To assemble a forum for leading regulators, enforcement experts and industry stakeholders to express views and concerns in order to enhance communication among actors in the compliance field.
- To identify global enforcement and compliance issues and corresponding compliance controls and solutions.
- To describe company best compliance practices through policy exchange and discussion.
- To utilize plenary panel discussions as a means of assessing medical device regulatory and compliance risks and sharing best practice responses.
- To offer a series of facilitated, interactive track sessions on key medical device compliance issues.
- To compare and contrast the various medical device global codes of conduct and assess approaches to multi code-compliance.
- To assess global compliance program operational issues, including infrastructure, monitoring, auditing and managing with limited resources.
- To identify and discuss advanced issues in promotion, inducements
and corrupt practices, including Foreign Corrupt Practices Act.
Ted Acosta, Esq.
Principal, Ernst & Young LLP
John T. Bentivoglio, Esq.
Partner, King & Spalding LLP
Vice President, Ethics & Compliance, ConvaTec, a Bristol-Myers Squibb Company
Mary C. Cade, Esq.
Vice President & Senior Counsel, Medtronic, Inc.
Partner, PricewaterhouseCoopers LLP
Brian W. Ellis
General Manager, Global Compliance, GE Healthcare
Linda Horton, Esq.
Partner, Hogan & Hartson LLP
Chief Compliance Officer, Sorin Group
Keith M. Korenchuk, JD, MPH
Of Counsel, Covington & Burling LLP
Maurits Lugard, Esq.
Partner, Sidley Austin LLP
Vickie L. McCormick|
Chief Compliance Officer, St. Jude Medical, Inc.
Vice President, Global Ethics and Compliance, Hospira
Sue Seferian, Esq.
Assistant General Counsel, Johnson & Johnson
Lynn Shapiro Snyder, Esq.
Member, Epstein Becker & Green
Paul J. Silver
Managing Director, Life Sciences Advisory Services, Huron Consulting Group
Chief Executive Officer, Medical Technology Association of Australia
Lincoln Tsang, Esq.
Partner, Arnold & Porter
Compliance Manager EMEA, Zimmer GmbH
Christopher L. White, Esq.
Executive Vice President, General Counsel, and Secretary, AdvaMed