LHR Consult offers legal advice, quality management and administration of information security/ data privacy (GDPR etc.) within the healthcare business, e.g. pharma/biotec (clinical drug develop-ment, pharmacovigilance, GxP etc.) and tissues & cells (fertility/assisted reproduction, stem cells, scientific research etc.) - as well as other academic disciplines of the public/private sector.
Tissues and cells
- Advicing on quality, safety and ethical aspects of tissue/cell activities, e.g. procurement, testing, processing, preservation/storage, coding, matching, distribution, import/export, ART and research.
- Advicing on donor management, screening, egg/ sperm quality, aseptic/sterile production, lab equip-ment (IQ/OQ/PQ), PPE etc. (GxP, OECD, WHO etc.).
- Advicing on the upstart of new tissue/donation sites.
- Acting as Responsible Person.
Privacy and data protection
- Mapping data inventories, systems, flows and requirements for global markets (EU, UK, US etc.).
- Privacy risk assessing of all business areas (PIA/DPIA) using appropriate risk models.
- Implementing and operating privacy programs in alignment with ISO 2700X/2770X/29100 etc.
- Providing privacy program awareness and training.
- Acting as Chief Privacy Officer, Data Protection Officer, EU Representative etc.
- Preparing and maintaining frameworks and documentation (ISO 900X, GxP, OECD, WHO etc.).
- Establishing, monitoring and analyzing metrics/indi-cators (trending, ROI, resiliency and maturity).
- Preparing and executing internal/vendor audits.
- Managing inquiries, deviations/non-conformities, complaints and incidents (root causes, corrective actions, change control, reporting etc.).
- Acting as Quality Responsible.