Doing Business in the EU: A Life Sciences Summit Complying with Pharma and Device Regulations
Product Details
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
Featured Sessions and Speakers
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.
- 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.