All those who manage the quality system must "undergo" inspections and audits by regulatory or certification bodies (JACIE, CNT, CNS, CRS, CRT).
During this meeting, strategies and operational tools will be provided to effectively prepare for the various inspections.

ICMED srl has developed a training course aimed at creating the role of Internal Hospital Risk Manager (IHRM).
The IHRM is that professional figure capable of designing a risk management system suitable for its healthcare facility, integrating it into its own company Quality System, equipping itself with a methodology and tools not only aimed at preventing the
risk, but also event management, supporting the Clinical Risk Manager in all aspects relating to the design and implementation of a system
risk management.
The course, in addition to issuing ECM credits, will be qualified by ACS Italia, a certification body for publicly controlled personnel.
Participation in the course constitutes one of the preparatory requirements for
achievement of the ACS skills certification which will be issued upon successful completion of the final exam of the course.
Once qualified, the learner will officially become part of the international register.

Quality standards increasingly require centers to implement internally a system aimed at validation and validation. One of the elements that must be validated in a transplant center, transfusion service and fertilization center is the IT system.
During this path, the validation method of IT systems will be illustrated, providing operational tools for the validation itself.

The aim of the course is to maintain the level of qualification for all those who work in the CAR-T Unit and Cell Therapy Unit.

In particular, during the training course, the center's compliance will be analyzed in light of current European and national legislation, examining the necessary requirements required by the legislation.

Furthermore, the role of the "Car-T Specialist" and the Gene Therapy Expert in the two is illustrated
job prospects: sponsoring company and clinical center.

The course aims to analyze the method of application of the requirements required by the
GDPR within transplant centers, tissue institutes and ART centers.
After having addressed the issue of the GDPR on a general level, we will proceed to illustrate the main problems present at the regulatory level in the specific reality.

The course aims to provide participants with the tools to be able to implement, manage and improve their quality system within a UFA, relating to all the activities provided within it.
After analyzing the difference between certification and accreditation, the main characteristics of the GMP and Pharmacopoeia regulations will be identified.

Quality system development models will be proposed
risk management and then conclude with an introduction to the concept of auditing.
Participation in the course constitutes one of the preparatory requirements for obtaining the ACS skills certification which will be issued upon successful completion of the final exam of the course.
Once qualified, the learner will officially become part of the international register.

Description

In recent years we have witnessed an increase in the availability of new drugs capable of "engaging" the patient's immune system in the fight against multiple pathologies, especially with reference to the oncology-hematology sector. Cellular therapies represent in all respects the first step towards personalized medicine for pathologies that are currently untreatable. The high quality standards required for the management of clinical trials involving Cellular Therapies produce an imminent need for qualified personnel, both in healthcare facilities and in pharmaceutical companies.

The aim of the course is to create the role of Quality Manager in a Fertilization Centre. During the course, participants will be provided with the tools to be able to design, implement, manage and improve the organizational and quality system of a fertilization center, in compliance with regulatory requirements at both a national and international level.

The course is qualified by the skills certification body ACS Italia. At the end of the qualification process, after passing the exam, the participant will be registered in the international register of QUALITY MANAGERS IN PMA CENTERS