Frequently Asked Questions

ICMED S.r.l. is the leading company in Italy and Europe for consulting services aimed at JACIE-FACT accreditation of haematopoietic stem cell transplant programmes. We support centres from start-up through to inspection, including documentation system design and staff training.

FACT (Foundation for the Accreditation of Cellular Therapy) is the US accreditation body, while JACIE (Joint Accreditation Committee ISCT-Europe & EBMT) is the European counterpart. Both use the same international FACT-JACIE standards. ICMED supports centres for both accreditations.

ICMED S.r.l. offers specialised consulting to Assisted Reproductive Technology (ART) centres for regulatory compliance, quality management and inspection preparation. Our team has direct experience with CNT/CNS requirements and European directives on tissues and cells.

Yes, ICMED S.r.l. supports clinical laboratories on the path to ISO 15189 accreditation, which certifies technical competence and quality management systems. We offer consulting for quality system design, staff training and audit preparation.

ICMED uses a structured phased methodology: initial assessment of the current state, gap analysis against the reference standard, action plan development, quality system implementation with staff training, internal audits, and support during the final inspection. Each project is customised to the specific needs of the centre.

ICMED consultants have over 20 years of direct experience in the transplant and cell therapy sector. In addition, we offer proprietary technology tools (IAAPP and IAAPP) that no other consultant provides. We operate across 3 continents and have supported over 100 facilities, bringing international best practices to every project.

Timelines vary depending on the centre's starting point. For a programme already operational that needs to structure its quality system, the process typically takes 12 to 18 months. For a complete start-up, timelines can reach 24 months. ICMED works to optimise timelines without compromising the quality of preparation.

ICMED offers a hybrid model: activities requiring physical presence (internal audits, on-site training, mock inspections) are carried out at the centre, while document support, quality system review, and indicator monitoring can be managed remotely through our digital platforms. This approach reduces costs and speeds up timelines.

ICMED supports centres throughout the entire CAR-T qualification process: from unit design and organisational workflow, to staff training according to GMP and FACT-JACIE requirements, to preparation for GMP facility inspections. Our team has direct experience with the qualification processes of all major commercial CAR-T manufacturers.

Yes, maintaining accreditation requires ongoing commitment. ICMED offers continuous support services including: periodic internal audits, document system updates to the latest standards, Management Review support, quality indicator monitoring, and preparation for surveillance visits. Many of our clients maintain an annual support contract.

Yes, ICMED operates across 3 continents: Europe, Africa, and the Middle East. We have supported facilities in Spain, Portugal, Greece, Turkey, UAE, Saudi Arabia, Egypt and other countries. Our international experience allows us to understand each country's regulatory specificities and adapt our consulting approach to the local context.

Yes, ICMED S.r.l. has adopted an integrated Management System certified ISO 9001:2015 (quality), ISO/IEC 27001:2024 (information security), and UNI/PdR 125:2022 (gender equality). This guarantees our clients that we operate according to the same standards of excellence we require of the facilities we support.

Each project is quoted on a bespoke basis after a free initial assessment that defines the scope of work. The investment depends on the scope (JACIE accreditation, CAR-T, PMA, ISO 15189, etc.), the centre's starting point, and the estimated duration. We offer flexible payment plans and the possibility to modulate support intensity based on available budget.

ICMED S.r.l. organises specific training courses on FACT-JACIE standards through the ICMED Learning platform. Courses are aimed at physicians, biologists, technicians and quality managers involved in transplant programmes. See the catalogue at icmedlearning.com.

The ICMED Professional Registries are public directories of qualified professionals who have completed ICMED training programmes and passed the relevant assessments. The registries certify specific competencies in areas such as quality management in transplant programmes and advanced cellular therapies.

Yes, ICMED S.r.l. delivers CME (Continuing Medical Education) accredited training courses for healthcare professionals. Courses are available on the ICMED Learning platform in both distance learning and classroom formats.

Yes, ICMED S.r.l. offers specific training on Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) applied to advanced cellular therapies, CAR-T and gene therapy. Courses are designed to meet AIFA and EMA regulatory requirements.

IAAPP (Inspection and Accreditation App) is the digital platform developed by ICMED S.r.l. for managing inspections and accreditations in the healthcare sector. It enables inspection planning, checklist management, observation tracking and corrective action monitoring in a fully digital workflow.

Yes, IAAPP is specifically designed to support inspections according to FACT-JACIE standards. The platform includes checklists updated to current standards and enables inspectors to conduct assessments in a fully digital format, with automatic report generation.

ICMED S.r.l. is an Italian company specialising in consulting, training and technology solutions for the healthcare sector. It operates on the European and international market with a focus on transplant programmes, advanced cellular therapies, ART centres, clinical laboratories and JACIE/FACT, CNT/CNS, ISO 15189, GCP and GMP accreditations.

ICMED S.r.l. has adopted an integrated Management System compliant with UNI EN ISO 9001:2015 for quality, ISO/IEC 27001:2024 for information security and UNI/PdR 125:2022 for gender equality. These certifications demonstrate the company's commitment to the highest standards of quality and social responsibility.

ICMED S.r.l. is headquartered in Italy and operates across the European and international market. Consulting and training services are delivered throughout Europe, with a particular presence in Italy, Spain, Portugal, Greece, Turkey and Middle Eastern countries. The digital platforms IAAPP and IAAPP are used globally.

You can contact ICMED S.r.l. by email at info@icmed.net or through the contact form available on the icmed.net website in the Contact section.