Cristiana Spontoni
Cristiana Spontoni is internationally recognised 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.
Cristiana advises clients from the pre-market phase, including clinical trials and pre-market authorisations, 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 recognised 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.)
Practice Area
Panels
- Consulting Editorial Board
- Contributing Author
Qualified Year
- 2002
Membership
- Brussels and Rome Bar Associations
Education
- Collegio Europeo di Parma (LL.M. with distinction 1995)
- Universita degli Studi di Roma "La Sapienza" (Law Degree summa cum laude 1994)
3 Contributions by Cristiana Spontoni
PRACTICE NOTES
ADR in Life Sciences Disputes: Practical Guide to Arbitration, Mediation, Expert Determination and ENE, with Advantages, Limitations, Confidentiality, Interim Relief Issues and WIPO Options for Complex, Multi-jurisdictional Collaborations
What is Alternative Dispute Resolution?
Alternative Dispute Resolution (ADR) is an umbrella label for methods that settle disputes without resorting to litigation. ADR is increasingly chosen to address life sciences conflicts. This Practice Note will set out the key benefits and limitations of different ADR models for disputes arising in this field and offer practical guidance on making the most of each route. For broader guidance on ADR, as well as a detailed comparison of processes, see Practice Note: What is ADR?
The advantages of ADR for life sciences disputes
Life sciences disputes are diverse and often turn on complex, highly technical topics. Even so, several recurring characteristics mean ADR can be well-suited in the right circumstances.
Disputes are multi-jurisdictional
The life sciences industry frequently involves cross-border collaborations, with participants across Asia, Europe and North America. Clashes may emerge from differing corporate cultures and/or divergent legal systems. For these matters, ADR can be a compelling alternative to litigation. Pharmaceutical companies often enter into commercial agreements and licences with third parties overseas in order...
Life Sciences
PRACTICE NOTES
EU and UK GDPR for Life Sciences: clinical trials, special category data, research, governance, transfers and sanctions; DUAA 2025–26, EHDS, Data Act and EU AI Act
General Data Protection Regulation (EU GDPR) and UK GDPR
The General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR), became enforceable across the EEA (which then included the UK) on 25 May 2018. Life sciences organisations frequently collect and/or process substantial amounts of personal information, including health-related data, about individuals (or ‘data subjects’) such as patients and clinical trial participants. As a result, the relevance of the EU GDPR and the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR) (which applies after the UK’s withdrawal from the EU) for life sciences companies cannot be underestimated.
Assimilated law is the term used for retained EU law (REUL) that remains operative after the end of 2023. The reclassification of REUL (and related terminology) as assimilated law marks a change in its status and handling under UK law, in that it is generally to be interpreted according to ordinary domestic legal principles. From 1 January 2024, REUL is ‘assimilated’ into domestic law because it is, in most cases, stripped of EU-derived interpretative effects (for example, the supremacy of EU law, directly effective rights, and general principles previously retained under the European Union (Withdrawal) Act 2018). For further information, see Practice Note: Assimilated law and...
Life Sciences
PRACTICE NOTES
EU GDPR in the life sciences: health data, research, consent, pseudonymisation, compliance, transfers, and interplay with pharmacovigilance, MDR/IVDR, EHDS, the Data Act and the AI Act
The General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR)
The General Data Protection Regulation (Regulation (EU) 2016/679, the EU GDPR) has applied across the EEA since 25 May 2018. Organisations in the life sciences gather and/or handle volumes of personal information, including health data, relating to individuals (the ‘data subjects’), notably patients and participants in clinical trials. As such, the relevance of the EU GDPR to life sciences businesses is considerable. This Practice Note outlines elements within the EU GDPR framework that have a direct bearing on life sciences companies and their operations. It is not an exhaustive treatment of the EU GDPR and should be read alongside the following Practice Notes: Data protection principles; Processing personal data—standard of consent; and Processing personal data—obtaining, recording and managing consent. For further detail on how clinical trials interface with data protection rules, see Practice Note: Conducting clinical research—data protection implications. Note, this Practice Note addresses provisions of the EU GDPR that apply in EEA countries at the supranational level only—consult guidance from the competent national data protection authorities and domestic legislation for the approach in any given EEA jurisdiction. For a primer on the EU GDPR framework, bringing together key practical...
EU Law
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