Cristiana Spontoni is internationally recognized as a leader in life sciences, including biotechnology, pharmaceuticals, medical devices, food and cosmetics, as well as in general EU product and industries regulation. She is also actively involved in the shaping and interpretation of EU legislation affecting many different regulated industries and has successfully represented clients in legislative challenges based on EU law. Cristiana frequently coordinates large international assignments and provides comprehensive one-stop-shop solutions for cross-border regulatory issues affecting clients' operations. She has coordinated projects in more than 80 countries worldwide and is co-leader of the Firm's Health Care & Life Sciences Practice.
Cristiana advises clients from the pre-market phase, including clinical trials and pre-market authorizations, to post-market issues, including product liability, marketing/advertising, distribution, and compliance (including sector-specific antibribery and data privacy).
Cristiana handles safety and compliance issues for a large variety of clients both in the life sciences and consumer products sectors, including in regards to product regulation, crisis management (e.g., recalls), regulatory enforcement and media attacks, as well as in marketing/advertising/claims and associated substantiation matters.
Cristiana frequently speaks at and chairs major international conferences. She is recognized in the leading lawyer directories including Chambers, Legal 500, Best Lawyers, and International Who's Who and has received several important awards, including "Life Sciences Lawyer of the Year"(Corporate LiveWire 2018 Global Awards) and the ILO Client Choice Award for EU-wide Healthcare & Life Sciences. She has been named a "Star" by LMG Life Sciences and Acritas.
The following represents experience acquired prior to joining Jones Day.
Advised a pharma and medical device manufacturer in connection with product liability claims associated with participation in a clinical trial in Europe.
Coauthored a report, on behalf of the Kuwaiti government, on the legal implications of the creation of a high-technology hub, addressing issues such as cybersecurity laws and biotechnology regulation.
Advised a fashion giant in the sale and marketing of cosmeto-textile products on a pan-European basis.
Led a global due diligence exercise in connection with the successful US$800 million sale of the diagnostic business of a major Japan-based medical device manufacturer.
Advised a major satellite operator in the successful bid to obtain frequencies for the operation of mobile satellite services in the first ever EU-wide award procedure launched by the European Commission.
Acted as strategic and regulatory counsel to one of the world's leading clinics in connection with the internationalization of its activities in Europe.
EU Commission Proposes Extended Deadlines to Comply with the Medical Device Regulation and In Vitro Diagnostic Regulation
- December 7, 2022
Jones Day Webinar: Cross-Practice Issues in the Life Sciences, Health Care Regulatory: Trends and Issues in Enforcement and Whistleblower Claims, Speaker
- September 5-9,2022
Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker "Clinicals Trials: What You Need to Know" Cambridge United Kingdom
- May 17-19, 2022
EU Pharmaceutical Law Forum 2022, "New Development for Data and Legal Implications in the European Healthcare Landscape", Speaker, Brussels, Belgium
- March 7, 2022
Medicines development and access to medicines after the COVID-19 pandemic: EU regulatory law and upcoming changes, Speaker, HELA Spring Conference, Harvard University
- January 17-21, 2022
Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker
- December 1, 2021
Jones Day Webinar: Cross-Practice Issues in Life Sciences M&A, Regulatory: Doing a Global Deal: The Regulatory Dimension, Speaker
- May 19, 2021
"Digital Innovation", EU Pharmaceutical Law Forum 2021, Session Chair, Brussels, Belgium
- September 15-17 & 23-24, 2020
13th Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker
- September 9-12, 2019
12th Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker
- June 18, 2019
EU Regulations, Annual Life Sciences Seminar, Speaker
- September 26, 2018
Annual Congress of the Dutch Clinical Research Foundation, Keynote Speaker
- September 10-13, 2018
11th Annual European Pharma Law Academy – Pharmaceutical Law Downing College, Cambridge University
- June 19-20, 2018
"Recognizing Your Own Leadership Style and Learning How to Be Perceived as a Leader", Women Leaders in Life Sciences Law
- March 6-7, 2018
CTR, MTR and GDPR – The Big Bang of New EU Regulations Impacting The EU Clinical Regulatory Landscape, CBI’s EU Clinical Trial Regulation Summit
- November 28-29, 2017
EU Clinical Trial Regulation, Speaker, Informa's Clinical Trial Supply
- March 14-15, 2017
New personal data protection regulation in the EU and potential applications to the plasma collection, Speaker, International Plasma Protein Congress 2017
- November 9, 2016
Jones Day Global Life Sciences Conference – 2016 Issues & Trends
- June 9, 2016
Transparency in the Pharmaceutical Sector, Pharmaceutical Contract Management Group Annual Conference, Speaker
- March 30, 2016
"Driving Resilient Partnerships for Growth", Pharmacon China, Speaker
- March 22-23, 2016
International Plasma Protein Congress, Speaker
- February 2, 2016
"Conflict resolution", Pharmaceutical Contract Management Group, Speaker
- September 17, 2015
“Sunshine Act”, “Doctor-Initiated Clinical Study” and“Off-label Promotion and FCA claims”, Jones Day Conference on Enforcement and Compliance Trends in the Life Sciences Industry, Speaker
- September 9, 2015
“M&A in Life Sciences”, Annual Conference of China’s Private Equity Association, Speaker
- June 15, 2015
Plasma Protein Forum, Speaker
- June 10, 2015
Advertising and Food Products - Which Rules and Which Trends in Europe? - The European Rules of Food Communication, Speaker
- April 22, 2015
Pharmaceuticals Regulatory Developments Including New Clinical Trials Legislation, Women Leaders in EU Life Sciences Law, Speaker
- March 4, 2015
Negotiating an Effective Clinical Trial Agreement and Limiting Litigation Exposure, ABA Life Sciences Legal Summit, Speaker
"A real star" and "One of the best."The Legal 500
- Collegio Europeo di Parma (LL.M. with distinction 1995); Universita degli Studi di Roma "La Sapienza" (Law Degree summa cum laude 1994)
- Belgium (EU List) and Italy
- Civil Servant, European Commission, Brussels (1996-1997); Trainee, European Council of Ministers (1996); Trainee, Italian Attorney General's Office (Avvocatura Generale dello Stato) (1995-1996)
Chambers: "excellent," "keen business sense," "smart, very precise, well regarded and well connected"
The Legal 500: "an exceptional lawyer with very good knowledge about industry regulation and practice, very easy to work with and extremely efficient"
LMG Life Sciences: "Life Sciences European Union Star"
International Who's Who of Life Sciences Lawyers
Life Sciences Lawyer of the Year, Corporate LiveWire Global Awards, 2018
Acritas "Star Lawyer"
- English, French, and Italian