Back in 2012, I took up new a position as Quality Manager/Responsible Person in a small Danish sperm bank. Over the next eight years, I developed, implemented and maintained the company quality management system within- and outside the EU – according to local requirements, and international guidelines such as ISO 900X, GxP, ICH, WHO, EDQM and  OECD.

As Responsible Person (Danish Tissue Order §4/5), I ensured that all licensed activities were conducted with proper regard for the regulatory framework regarding traceability, consents and contracting, permits and authorizations, employee qualifications and training, record keeping, reporting and submissions and quality assurance etc.

In line with company strategies, I set the direction for a common understanding of quality, safety and business ethics. Combined with an innovative product development and a comprehensive customer service, the organization soon established itself as brand-leading in Europe, and a pioneering player on the global fertility market.

As an independent consultant since 2020, I have been associated with a number of fertility clinics and sperm banks (amongst other tasks), and acted as the Responsible Person, conducted audits, produced quality documentation and prepared for future permits.

I hold a number of certificates in quality/risk/project management, auditing, GxP, medical genetics etc., and have worked closely with fertility clinics, sperm banks, general practitioners, laboratories, accreditation providers and regulatory authorities.

Additionally, I take part in relevant lectures/webinars, network meetings, and training activities at a number of national/international fertility societies/fora (e.g. ESHRE, EFS, Nordic Fertility Society and Dansk Fertilitetsselskab).

Based on the above, LHR Consult offers the following services:

• Providing guidance and professional expertise on tissue/cell activities (egg/sperm, stem cell, cornea etc.), e.g. donation/procurement, testing/screening, processing, preservation, storage, matching, sale, distribution/export, import, assisted reproduction, scientific research – and related  legislation/guidelines (DK, UK, DE etc.).
• Providing professional advise on authorization, registration, healthcare professionals obligations, patient rights, permits, organization and management, facilities, staff, equipment and materials, contracts with third parties, documentation and record keeping, reporting obligations, traceability, good tissue practice etc.
• Acting as Responsible Person (Tissue Order §4/5).
• Preparing, implementing and maintaining documentation and quality/document management systems (ISO 900X, GxP, ICH,  OECD, WHO, EDQM etc.).
• Risk management of all business areas, e.g. donation/procurement, cross contamination, mix-up’s, storage, distribution, import, recall and return to stock (ISO 31000, ICH/FMEA etc.).
• Identifying/implementing, monitoring and evaluating key performance indicators (KPI) and other controls – for oversight and governance.
• Preparing, concluding and maintaining contracts and agreements, terms and conditions, consent forms etc. (general practitioners, laboratories, suppliers, tissue establishments,  clients/patients etc.).