EU REPRESENTATION & DATA PRIVACY FOR CLINICAL TRIALSBiotechnology . Food . Healthcare . Medical Devices . Pharma
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EU Clinical Trial Representation
Your company is not established in the EU and conducts clinical trials in the EU? Under EU regulation (GDPR and Clinical Trial Regulation), you may be under the obligation to appoint an EU representative. Hussard provides compliant, efficient and cost effective EU representation for clinical trials.
Our services include:
- NWritten Annual Mandate
- NGDPR Compliance Assessment
- NCooperation with Supervisory Authorities
- NContact point for EU Patients
- NContracts Review (protocole, CTA, NDA, etc.)
A La Carte
Hussard can help address all data privacy issues (GDPR) in any business context. We can deliver ongoing international data privacy compliance support to data controllers and processors.
Our support can be structured to meet your needs including by providing external Data Protection Officer (DPO) services.
Our services include:
- NRecord of Processing Activities
- NData Protection Impact Analysis (DPIA)
- NContracts and International Transfers of Data
- NAccess Rights & Data Breaches Management
- NTraining and Workshops
The Payoff for Compliance is Trust.
Who We Are
Hussard is a niche legal service provider specialised in data privacy and EU representation for clinical trials.
Founder & CEO
Before founding Hussard, Gauthier has been an active member of the Brussels bar for 20 years, working for international law firms in Brussels and London. Gauthier holds a Master Degree in Law of the University of Louvain and a Post-Master Degree (LL.M) in European Laws of the University of Edinburgh. Gauthier followed several executive courses at Harvard Law School. Gauthier has a double privacy certification, CIPP/E and Solvay Business School, and a certification in Good Clinical Practice (GCP).
He is external Data Protection Officer (DPO) specialized in life sciences and clinical trials. He advises several biopharma companies on GDPR compliance and lectures on clinical trials at the Belgian Pharmaceutical Federation (Pharma.be).
Charlotte De Raef
Before joining HUSSARD as a Partner, Charlotte was a member of the Brussels Bar. She has been working for business law firms in Brussels for seven years. Her practice focuses on data privacy, IP/ICT, contracts and business law.
Charlotte holds a Master Degree in Law from the University of Louvain and specialises in IP with a LL.M from the University of Leuven. Charlotte is certified CIPP/E and member of the International Association of Privacy Professionals (IAPP). She is active as an external Data Protection Officer (DPO) and EU legal representative in data privacy (GDPR) for non-EU biotech’s and pharma companies. Charlotte is also legal expert for the Belgian Association of Marketing (BAM) and lectures on innovation and digital marketing. She speaks French, Dutch and English.
Our team comprises seasoned certified lawyers and technical experts (DPO) with strong expertise and the right skillsets to manage the complexity of international business.
Hussard is expert in GDPR and a leader in Data Privacy Compliance.
We focus on EU representation for clinical trials. We have tailored our compliance processes for this segment.
We are an independant legal firm and open to share our experience with your teams
World-class health cluster
- NEU leader in clinical trials phase I
- NLocated at the very heart of Europe
- NTax incentives for R&D expenses
- NEnglish widely spoken
Industrial and academical players
- NGlobal pharma leaders
- NBiotech ecosystem
- NPrivate research centres
- NLeading universities
Favorable regulatory framework
- NPharma friendly approach
- NProximity to EU institutions (EDPB)
- NCollaborative supervisory authority
- NPrior consultation
- NCell therapy
- NMedical devices
Chaussée de Bruxelles, 135A/3 WIP
B -1310 La Hulpe