Doing Business in the EU: A Life Sciences Summit Complying with Pharma and Device Regulations

This conference has been cancelled.

Every drug and device manufacturer who wants to operate in the European Union (EU) — or is looking to expand — needs to understand the EU regulatory environment to avoid unnecessary scrutiny, product delays or financial penalties that could sink their companies.

Discover what you need to do to navigate the nuances of the EU market with guidance from those who have been there and succeeded. At Doing Business in the EU: A Life Sciences Summit, industry experts from both the EU and the U.S. will reveal what they’ve learned from years of working in the trenches every day. No other conference will give you the knowledge you need to prepare for challenging EU legal, regulatory and compliance requirements — get your game plan here.

You’ll gain first-rate knowledge on:

  • The application of the competition rules in the pharma and device sectors — a EU/U.S. perspective
  • Differences between FDA and EU approaches to pharmacovigilance compliance
  • Complying with the Foreign Corrupt Practices Act (FCPA)
  • CE marking — maintaining EU compliance under changing rules
  • An international harmonization update from the FDA perspective
  • How one improper sales conversation or marketing promotion can cause serious violations of EU regulations — real-world compliance strategies
  • Best practices and strategies for complying with the EU’s EudraVigilance system
  • Protecting patient safety — conducting compliant clinical trials in the EU in the wake of TeGenero

Click here to view the brochure.

Click here to view the agenda.

Featured Sessions and Speakers

CE Marking: Obtaining and Maintaining EU Compliance Under the Recent Medical Device Directive
Eric Henning, Senior Project Manager, KEMA Medical
Differences Between FDA and EU Approaches to Pharmacovigilance Compliance
Annalisa Pizzarello, Head of Global R&D Compliance, Amgen, Inc.
Focused Learning Session: Protecting Patient Safety — Conducting Compliant Clinical Trials in the EU in the Wake of TeGenero
Jan Murray, Deputy General Counsel, Cleveland Clinic Foundation
Conference Sessions and Speakers
Welcome to the EU: Doing Business in the EU’s Life Sciences Sector
  John Bruton, Head of Delegation, European Union — Delegation of the European Commission to the United States (Invited)
The Application of the Competition Rules in the Pharma and Device Sectors — An EU/U.S. Perspective
Barry Pupkin, Partner, Squire, Sanders & Dempsey L.L.P.
Brian Hartnett, Partner, Squire, Sanders & Dempsey L.L.P.
One Improper Sales Conversation or Marketing Promotion Can Cause Serious Violations of EU Regulations: Real-world Compliance Strategies
Cristiana Spontoni, Partner, Squire, Sanders & Dempsey L.L.P.
Focused Learning Session: Data Protection and Privacy Rules — Comprehensive EU/U.S. Comparison
Scott Edelstein, Partner, Squire, Sanders & Dempsey L.L.P.
Andrew Wilkinson, Partner, Squire, Sanders & Dempsey L.L.P.
Moderator: Maureen Bennett, Partner, Squire, Sanders & Dempsey L.L.P.
Regulatory Framework Applicable to Biobanks in Germany, Switzerland and Austria
Karina Hellbert, Partner, Fiebinger, Polak, Leon & Partner Rechtsanwälte GmbH
EU Privacy Regulations in the Era of Genomics
Tobias Schulte in den Bäumen, Chair of the Legal Working Group, German Center for Public Health Genomics, University of Applied Sciences
Best Practices and Strategies for Complying With the EU’s EudraVigilance System

Kathy Lenard, Senior Director, Pharmacovigilance, Centocor R&D
Changing European Patent Strategies — Are You Prepared?
Edward Nodder, Partner, Bristows
International Harmonization Update from the FDA Perspective
  David Kelly, Associate Director for International Harmonization, Europe, FDA (Invited)
Complying with the Foreign Corrupt Practices Act (FCPA)
Rebekah Poston, Partner, Squire, Sanders & Dempsey L.L.P.
Focused Learning Session: Protecting Patient Safety — Conducting Compliant Clinical Trials in the EU in the Wake of TeGenero
Jan Murray, Deputy General Counsel, Cleveland Clinic Foundation
Cristiana Spontoni, Partner, Squire, Sanders & Dempsey L.L.P.
Moderator: Maureen Bennett, Partner, Squire, Sanders & Dempsey L.L.P.

Continuing Legal Education (CLE)
CLE is pending approval in AZ, CA, FL, GA, IN, IL, MN, NY, NC, OH and PA for between 10.75-13.00 general hours of CLE.

Who Should Attend

  • Executive Management
  • Regulatory Affairs
  • Compliance Officers
  • Quality Assurance/ Quality Control
  • Research and Development
  • Sales and Marketing Officers
  • Consultants/Service Providers

About Squire, Sanders & Dempsey L.L.P.
Squire, Sanders & Dempsey L.L.P. is a multi-jurisdictional law firm with more than 850 lawyers practicing in offices throughout the Americas, Europe and Asia. Squire, Sanders operate as a single global partnership, which ensures client accountability and the seamless delivery of uniformly high quality legal services throughout the world. Our lawyers come from many countries and cultures, are licensed to practice in both common law and civil law jurisdictions, and communicate with clients in their native languages.

About the Conference Chairperson

Cristiana Spontoni, Partner, Squire, Sanders & Dempsey L.L.P.

Cristiana Spontoni is an EU law expert with more than 10 years of experience in the life sciences sector (including biotechnology, pharmaceuticals and medical devices). Ms. Spontoni advises numerous clients from a premarket phase, including clinical trials and premarket authorizations, to postmarket issues including incident reporting, marketing and advertising practices and wholesale distribution. She manages cross-European and global assignments on behalf of her clients and has therefore a deep understanding of different regulatory systems around Europe and beyond. Ms. Spontoni is recognized as a leading practitioner in the EU life sciences sector and regularly publishes and speaks at international conferences in the life sciences area. Before practicing in the private sector she worked with the EU Council of Ministers and the European Commission in Brussels. Before that, she was with the office of the Italian Attorney General.

Location and Hotel Accommodations
To reserve your room, call the hotel at the number below. Be sure to tell the hotel that you're with FDAnews conference to qualify for the reduced rate. Only reservations made by the reservation cutoff date are offered the special rate, and space is limited. The hotel may run out of rooms before the reservation cutoff date. The discounted rate is also available two nights before and after the event, based on availability. The hotel may require the first night's room deposit with tax. Room cancellations within 24 hours of the date of arrival or "no-shows" will be charged for the first night's room rate plus tax.

Hilton Arlington
950 North Stafford Street
Arlington, VA 22203
Toll free: (800) HILTONS • Tel: +1 (703) 528-6000

Room rate: $201 single or double (plus 10.25 percent tax)
Hotel reservation cutoff date: August 29, 2008

The early bird discount ends Aug. 21, 2008, and the price is $1,697. Regular fee beginning Aug. 22, 2008 is $1,897.

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Team Discounts
Significant discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) 538-7600 for details.

In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Exhibitor Information
Exhibit locations and sponsorship packages are still available. For details, contact:

Andrew McSherry
Direct line: +1 (703) 538-7643
Alka Desai
Direct line: +1 (703) 538-7669