Caroline Manuel

4+ years PQE in US law firm

Experience in Data privacy and Life Sciences - EU law

French qualified lawyer - eligible to work in UK

Data Protection

• Advised clients on enquiries regarding the GDPR and assisted them in implementing thorough compliance schemes (including precise documentation and assessment of data processing activities).
• Reviewed and/or drafted tailored data privacy documents for clients, including general privacy policy, HR policy, ethical hotline policy, cookie policy, data retention policy, data breach policy.
• Drafted data subject consent forms and advised on requests from data subjects (general enquiry, information about collection of data, and right of erasure).
• Reviewed and negotiated third-party supplier contracts and client contracts with regards to data protection compliance.
• Mapped cross-border data flows and drafted/reviewed data transfer agreements.
• Advised global clients on national and EU e-privacy rules, including cookies, consent and direct marketing.
• Collaborated closely with the relevant data protection authorities in France, Belgium and Luxembourg for complex projects involving processing of sensitive data for clients in the Life Sciences (global implementation of a tele-cardiology system, global roll-out of a mobile health app and cloud-based reporting solution for wearable medical device for a medical device manufacturer).

Life Sciences Regulatory

• Advised pharmaceutical companies and medical device manufacturers on transparency and anti- gift laws.
• Advised US-based pharmaceutical companies with respect to the conduct of clinical trials in European sites (regulatory framework, agreements, processing of personal data).
• Assisted pharmaceutical companies on advertising and information.
• Carried out regulatory aspects of due diligence in M&A transactions when buyer/seller was operating in the Life Sciences industry.
• Assisted and regularly travelled with the UK Regulatory & Investigations team for clients in the pharmaceutical industry regarding internal anti-corruption investigations carried out on-site in Europe (Belgium and Romania) as well as in West Africa (Nigeria, Ivory Coast and Cameroon).
• Conducted legal research and performed case studies on various regulatory issues (conduct of clinical trials, pharmacovigilance, information and advertising of medicinal products on websites, cosmetic products regulation, processing of health data and privacy issues).
• Assisted pharmaceutical companies in relation with market access issues (pricing, reimbursement, generic drugs marketing authorisation (‘MA’), notification of variations in the MA).
• Prepared litigation cases (commercial litigation, product liability).

Business Development

Wrote significant number of articles on health care regulatory and data protection issues in paper and digital reviews (Digital Health Legal, Data Guidance Platform, Lexology Life Sciences / Compliance, eHealth Law & Policy, Getting the Deal Through – Pharma Antitrust, The Product Regulation and Liability Review) and prepared conferences (‘FCPA and Anti-Corruption for the Life Sciences Industry’ and ‘Focus on data privacy’ both for the American Conference Institute).

Paris Bar School (‘Ecole de Formation du Barreau’), Paris (2014)

Master II of Healthcare and Pharmaceutical Law (University Paris 5 Descartes), Paris (2013)

Master II of Business Law and Economics (cum laude)

Université Paris 2 Panthéon-Assas, Paris