18 years

PHARMACEUTICAL AND MEDTECH LEGAL EXPERIENCE

INTERIM AND FLEXIBLE LEGAL SUPPORT

Contracts

- Negotiation of R&D and commercial contracts for global top 5 innovative pharmaceutical and medtech companies, covering all aspects of drafting and negotiating commercial and R&D contracts (e.g. clinical trial-, material transfer-, services-, distribution-, licensing-, research-, collaboration-, consortium agreements)
- Modernised the contract management framework, incl. development of playbooks for contract negotiation (global, regional, local level) for global top 3 company
- Legal lead for re-structuring global procurement processes
- Deal mediation

regulatory

- Legal lead in various projects covering pharma and medical devices regulatory topics such as data strategy, real world evidence generation, AI, regulatory data protection, biosimilars, paediatrics (incl. PIPs), data access, tiered pricing, compassionate use, orphan designation, product qualification etc. for global top 3 company
- Legal lead in EU and global task force on regulatory data protection for pharmaceutical marketing authorisation application dossiers
- Detailed regulatory impact assessment of the HMA/EMA Guidance on Commercially Confidential Information and Personal Data
- Legal review of proposed implementation measures for the new Swiss Human Research Act
- Impact assessments of and comments to new regulations (incl. GDPR, Clinical Trials Regulation)
- AI and machine learning policy development and implementation for global top 3 pharmaceutical company
- Company representation in the European Federation of Pharmaceutical Industries and Associations (EFPIA)
- Data and real world evidence policy development for global top 3 pharmaceutical and medtech company
- Regulatory pathways identification / classification of medical software for top 3 medical device company
- Comprehensive advice on EMA qualification of novel technologies for top 3 pharmaceutical and medtech company
- Development of policy for scientific credibility together with internal stakeholders of a top 3 pharmaceutical company
- Legal opinions (e.g. privacy and use of AI in clinical trials and real world evidence (RWE) projects; digital health, pharmacovigilance obligations in RWE projects; regulatory data/dossier protection)
- Legal lead counsel for EU competition law matters
- Competition law analysis and legal opinion related to Swiss case law for a top 5 pharmaceutical company

compliance

- Development, implementation, review and update of Policies, Directives, Guidelines and functionally defined SOPs on all healthcare compliance topics, such as: interactions with HCPs / patient organisations, product promotion, medical education, medical information, disease awareness, grants/charitable donations, scientific publications for global top 3 company
- Legal and compliance review of global strategic marketing plans (all marketing and launch related activities)
- Development of training concepts for healthcare and corporate compliance topics in general (such as anti-corruption, competition law, data privacy etc) and numerous engagements as on-site trainer
- Development of training concepts and conducting training for marketing compliance topics (pharma and medical devices)
- Development of training concepts and conducting training for medical affairs compliance topics (pharma and medical devices)
- Development and implementation of global policy on scientific credibility in research
- Update of global publication policy and development of functionally defined SOPs
- Ad interim compliance manager during eight months for the Swiss affiliate of a global pharmaceutical company
- Representing a top 5 pharmaceutical company in the EFPIA working groups developing the EFPIA Disclosure Code (project lead and coordination with internal functions)
- Session chair for the DIA session on Transparency of Payments in the Healthcare Sector at the 26 th DIA EuroMeeting
- Counselling various pharmaceutical companies in the implementation of the EFPIA Disclosure Code and the corresponding national codices

Digital activities

- Legal lead for development and implementation of a global, non-commercial, medical information and scientific exchange platform for healthcare professionals) including all aspects of site structure, content, access restrictions, regulatory requirements based on target audience
- Development of global guideline and internal approval processes for digital activities (all global digital activities, such as website development, social media, apps, digital research/online listening etc)
- Legal and compliance lead for development of a pan-European website for a product with both Rx and OTC authorisations (public pages and HCP pages)
- Legal opinion on electronic signatures for Swiss based global healthcare organisation
- Development of legal disclaimers and instructions for user generated content in online repository for a Swiss based global healthcare organisation

Data privacy / gdpr

- Legal review of proposed implementation measures by a global top 5 pharmaceutical company regarding the new Swiss Human Research Act (with specific focus on health-related personal data)
- Review and negotiation of data processing agreements
- Overview and analysis of EU and national legislation in France, Germany, Italy, Spain and the UK for the re-use of patient level data
- Review and negotiation of data privacy clauses in the context of clinical trials
- Development of briefing documents for customers (incl. HCPs) on personal data processing
for digital health solutions

​Personalised Healthcare / Value based Healthcare / Digital Health / Big Data / AI

- Personalised- / Value -based healthcare policy development
- Qualification and classification of medical devices (esp. software)
- Determining EU regulatory pathway(s) for a digital self-screener software
- Analysis of marketing authorisation holder pharmacovigilance responsibilities in the establishment of a registry (patient registry)
- Development of compliance framework for digital health projects
- Legal advice regarding qualification of novel technologies, SaMD (EMA/FDA)
- Privacy aspects for digital health solutions
- Data policy strategy development – including development of genomic privacy- / anonymization- /data quality- / data interoperability- / data sharing bytes
- Review of and comments to the EU data governance and AI acts
- Review of and comments to the EC trade policy
- Inception impact assessment for the legislative framework for the governance of Common European Data Spaces
- Development of position paper on AI