EAHP represents over 30,000 hospital pharmacists across 37 member countries. EAHP represents and develops the hospital pharmacy profession within Europe in order to ensure the continuous improvement of care and outcomes for patients in the hospital setting. This is achieved through science, research, education, practice, as well as sharing best-practice and responsibility with other healthcare professional
The EAHP Board, elected for three-year terms, oversees the association’s activities. Comprising directors responsible for core functions, it meets regularly to implement strategic goals. Supported by EAHP staff, the Board controls finances, coordinates congress organization, and ensures compliance with statutes and codes of conduct.
The EAHP staff supports the Board in executing EAHP’s mission. The Staff assists in financial management, events organisations, policy activities and all EAHP projects. The EAHP staff works closely with EAHP’s members and ensures the effective communication all relevant stakeholders.
The first member countries were Belgium, Britain, Denmark, France, the Federal Republic, Germany, Italy and The Netherlands in 1972. EAHP has now 36 EAHP members and 2 Associate Members. EAHP is open to countries members of the Council of Europe and since 2022 to organisations representing the interests of hospital pharmacists from outside the Council of Europe (Associate Membership)
EAHP’s structure is also composed by different standing committes: EAHP Scientific Committee, EAHP Education Executive Committee and the EAHP CTF Steering Committee.
At EAHP, we are committed to transparency in our governance, ethical standards, and funding practices. This section provides open access to our foundational documents, including the EAHP Statutes, Code of Conduct, and Funding Sources. By sharing these resources, we aim to uphold accountability and foster trust with our members, partners, and the public.
Keep up with all EAHP’s events and webinars. Contact the team at info@eahp.eu should you have any questions about upcoming events or activities.
Here you can find all upcoming events organised by EAHP and by all its members and associate members. Do not hesitate to contact the events team at events@eahp.eu should you have any questions about the organisation of these events.
Hospital pharmacists conduct a critical role in the care of patients in hospitals. Learn more about what they do here and in all the pages under Hospital Pharmacy practice and Policy.
Self-Assessment
SILCC
Closed SIGs
EAHP brings together experts from many areas of hospital pharmacy practice providing and highlighting good local sustainable practices as that can be up-scaled and shared with other countries. The EAHP Working Group on Sustainability has the aim of reducing the environmental burden of the hospital pharmacy services.
The European Association of Hospital Pharmacists (EAHP), and its 36 member country platforms are creating a Common Training Framework for the hospital pharmacy education in Europe. The goal of this project is to allow the free movement of hospital pharmacists within the European Union.
The European Association of Hospital Pharmacists (EAHP) and the European Society of Clinical Pharmacy (ESCP) have collaboratively developed the Oath to Society. The Oath to Society is all encompassing and acts as a contract for excellence in providing compassionate patient care, working as part of the healthcare team and advancing the pharmacy profession, and showcasing how clinical and hospital pharmacists work every day
A day created to highlight the importance and to celebrate the work done by hospital pharmacies. This day celebrates all hospital pharmacy teams.
The Early Career Network aims to empower early-career pharmacists by sharing opportunities, insights, and success stories from across 25 member countries.
Together, we’re building a stronger, more connected hospital pharmacy community: one story, one country, one pharmacist at a time.
Catch up with EAHP’s press releases
Find all EAHP relevant publication like the EAHP Surveys, annual reports and the history books.
The European Journal of Hospital Pharmacy (EJHP) is the only official journal of the European Association of Hospital Pharmacists (EAHP) and is committed to advancing the science, practice and profession of hospital pharmacy. As the premier communication platform for hospital pharmacists worldwide, EJHP is a major source for continuing education as well as updates on advances in the practice and standard of pharmaceutical care for patients.
When EAHP and Hospital pharmacists appear in the news.
EAHP publishes a monthly EU monitor with updates about the latest EAHP initiatives and information relevant for the hospital pharmacy profession.
The Sponsor Channel is designed to maximise visibility and engagement, allowing sponsors to connect with the hospital pharmacy community and partners in a dynamic and interactive environment. From product demonstrations to networking sessions, the Sponsor Channel offers a range of opportunities for sponsors to showcase their offerings and generate leads in the new EAHP Website.
Patient Safety and Quality Assurance
Christina Theil Schnor and Saranya Loganathan.
In 2018, hospitals in Region Zealand (RZ), Denmark, transitioned to the electronic health record (EHR) system, EPIC. Following this, hospital pharmacists faced repeated medication order challenges causing adverse events such as inappropriate medication orders, dispensing and administration errors, and insufficient workflow coordination. These issues resulted in complex, time-consuming workflows impacting quality and patient safety. Additionally, collaboration between corporate IT and clinical staff was challenged by a lack of understanding of practical issues. To address this, pharmacists of RZ established the Clinical Pharmaceutical Service IT Team (CPS IT Team) to build specialized knowledge of the EHR medication module, aiming to assure quality, optimize workflows, strengthen interdisciplinary coordination, and support safer and more efficient clinical use.
CPS IT Team standardized workflows, enhanced coordination of medication order tasks, and created a forum to effectively utilize professional knowledge and networks across areas.
To address diverse Clinical Pharmacy challenges, CPS IT Team became the bridge between internal organization (RZ Hospital Pharmacy and corporate IT) and external partners (EPIC and The Capital Region of Denmark (CRD)). For this reason, CPS IT Team was established with one team manager and two units: Internal and External unit. CPS IT Team continuously adapts to evolving Clinical Pharmacy needs.
The establishment of CPS IT Team has driven significant internal optimization and standardized workflows. Acting as a coordinating unit, it optimizes medication processes from ordering to dispensing and administration. Dialogue with IT has been strengthened, enabling more efficient, targeted communication across professional groups.
Collaboration with EPIC and CRD has enhanced quality assurance and optimized workflows. CPS IT Team efforts have helped prevent medication-related adverse events, improve workflows, and optimize medication processes. Interdisciplinary collaboration and professional consultation networks between regional clinics, hospital pharmacies, IT, and EPIC have been notably strengthened. These efforts have increased patient safety and fostered a safer, more coherent workflow in EPIC.
Fusion of RZ and CRD into Region Eastern Denmark will change CPS IT Team’s working conditions, opening new opportunities such as an expanded collegial network and broader range of tasks and needs. Systematic data use will support Hospital Pharmacy’s work, improving efficiency and quality in daily operations.
Patient Safety and Quality Assurance
Inês Carmo, Ana Parola, Inês Oliveira, Margarida Carvalho, Marta Carvalho, Ana Mirco.
On April 28, 2025, a nationwide blackout affected Portugal, disrupting the national power grid and severely compromising the cold chain of vaccines in primary health care facilities, along with all forms of mobile communication. Given this event, the response by the Pharmaceutical Department (PD) of a Local Health Unit responsible for delivering vaccines to 38 Primary Health Care Facilities (PHCF) required evaluation due to major clinical, financial, and operational risks.
Vaccines exposed to any temperature excursion during storage were identified and placed under quarantine, preferably using an alternative cold storage unit with an independent power source, when available, and distinctly labeled. Through a standardized notification form, each incident was promptly reported within 48 to 72 hours to the cold chain supervisor and PS. During the first week after the blackout, PS reviewed each report to determine the vaccine’s stability and possible return to the supply chain.
Hospital pharmacists collected key data such as temperature variations, time outside safe range, and affected vaccine batches. They consulted reliable sources (databases and Summary of Product Characteristics) and sought information from the supplier laboratory. Upon analyzing all data, PHCF received precise recommendations on suitability for ongoing use.
On April 28, 2025, 40 cold chain incidents were notified, affecting 12,442 vaccines units. After thorough analysis, 12,202 units were authorizes for use, reducing clinical and economic impact. Only 240 units were discarded, resulting in a loss of 6,018.50 € out of a total stock valued at 284 544, 60 €. Joint action by Pharmacist and PHCF assured continuity of patient care and vaccine safety, preventing disruptions to the National Vaccination Program.
The nationwide blackout exposed vulnerabilities in the PHCF cold chain, highlighting the need for more refrigerators, continuous electronic monitoring, backup generators, refrigerated vehicles, and standardized protocols between PS and PHCF.
Patient Safety and Quality Assurance
Martín Santamaria, A. López Fernández, A. Menchén Viso, B. Sanabrias Fernández de Sevilla, R. Folguera Olias, C. Guerrero Feria, I. Herrero Collado, L. De España Zaforteza, P. Pérez García, E. Sánchez Guerrero, A.
Unnecessary disposal of high-cost injectables is often triggered by home storage errors, placing a burden on the public health system. The aim was to quantify avoidable expenditure through pharmacist review, and to identify opportunities for the education of targeted patients, prompted by these incidents.
A pharmacist-led stability verification program for refrigerated medicines stored at home was implemented. When an out-of-fridge incident was reported, stability was assessed by a pharmacist and, when safe, continued use was authorised, avoiding replacement costs.
A retrospective analysis was conducted of incidents recorded in an Excel database from 2021 to 2024. For each case, the following variables were collected: active drug, units affected, units saved, and costs (potential replacement and avoided cost). Stability decisions were based on summaries of product characteristics (SmPCs), manufacturer information, and published temperature-excursion evidence (Stabilis database, Fridge Stability Tool by NHS) interpreted against the reported time/temperature exposure.
From 2021 to 2024, 115 incidents were recorded, involving 288 injectable units; 66 were authorized for continued use, avoiding 18.590€ in replacement costs. Savings by year and share of the total were: 6.922€ in 2021 (37,2%), 5.498€ in 2022 (29,6%), 4.012€ in 2023 (21,6%), and 2.159€ in 2024 (11,6%). By year, injectable units saved/affected were: 2021: 28/46, 2022: 19/150, 2023: 6/33, 2024: 13/59. The most frequently implicated drugs were adalimumab (38), etanercept (10), darbepoetin alfa (10), filgrastim (7), and golimumab (4). These drugs were also the most frequently consumed across this period. A substantial proportion of excursions were cleared for safe continued use through a structured pharmacist verification process.
An infographic will be developed to standardise patient counselling: correct home storage (fridge placement, do-not-freeze warnings, time-out-of-refrigeration windows by product), safe travel with injectables (cool bags/ice packs, temperature monitoring, air/rail travel tips, hotel-fridge checks), and recommended actions after an incident—product quarantine, time/temperature recording, and immediate contact with the hospital pharmacy (email/phone). The infographic will be provided at first dispense and after any excursion, and its impact will be evaluated through subsequent incident and saved units rates.
Patient Safety and Quality Assurance
E. Bredenberg, M. Knuutila-Jerkku, P. Halonen, E.W. Gröndahl
On the ward, attaching infusion lines to cytotoxic doses is performed alongside busy clinical work, often resulting in delays. Centralized attachment of infusion lines to patient-specific cytotoxic doses in the hospital pharmacy cleanroom streamlines the chemotherapy workflow. It also enhances medication safety by improving the quality of ready-to-administer doses compared to the previous attachment practices on the ward.
In Turku, patient-specific cytotoxic doses are prepared for administration in the hospital pharmacy’s centralized compounding unit, located in EU GMP-compliant cleanrooms. This ensures aseptic preparation and emphasizes occupational safety. As part of this project, we included Cytoset Line® infusion sets pre-filled with saline into patient-specific cytotoxic doses during the centralized compounding process in the cleanroom.
To improve medication safety in chemotherapy, we held a multidisciplinary review of the process, consulted other hospitals for their practices and experiences, and assessed the stability of pre-attached infusion lines compared to non-attached doses.
The process of filling Cytoset Line® infusion lines with saline was introduced to pharmacists. The integrity of the closed infusion system was tested by adding caramel colour dye to the infusion bag. The effect of clamp placement was tested by positioning it at different points along the filled line. Caramel colour leakage into the line indicated insufficient sealing.
Performing the line attachment in a Grade A cleanroom improves aseptic conditions and reduces the risk of microbiological contamination. Occupational safety is enhanced by minimizing nurses’ exposure to cytotoxic agents. Centralized preparation optimizes the use of personnel resources. Correct placement of the clamp below the infusion port is critical in preventing contamination.
Expansion of the practice to other hospital units
Assessing the feasibility of attaching infusion lines to doses intended for extended storage
Standardizing processes: adopting uniform infusion lines across all oncology units (requirement for pre-attached infusion lines)
Patient Safety and Quality Assurance
Maria Teixeira; André Maia; Ana Catré; Inês Margalho; Joana Duque; Marisa Costa; Marta Susana; Miguel Paulo; Tomás Sousa; Vânia Pereira; Teresa Pereira
Thermolabile drugs require special storage conditions(2°C-8°C).[1] They represent a group with relevant economic value in Pharmaceutical Services(PS), therefore, processes must be guaranteed to maintain the storage temperature throughout the entire circuit.[2] CBR can cause changes in the characteristics of drugs and compromise their stability, efficacy and safety.[1,2] It is the responsibility of the PS to establish procedures and assess whether or not drugs exposed to a temperature excursion can be used.[3]
We analyzed the economic impact of Cold Chain Breaks (CRB) occurring in Primary Health Care (PHC) at the Local Health Unit (ULS).
A spreadsheet document was developed for action in cases of CRB for PHC, and a database was created with the responses provided by the laboratories. The document is sent to the PHC unit, to be completed by the nurse in charge, who identifies the cause, duration, temperature reached, and medications in the refrigerator. After analysis by the PS, a report is sent with information on stability studies and respective conclusions per item. The excursion is then valued based on the average price of the item and the available quantity. A database was created with the valuation of all CRBs.
Between April 2024 and July 2025, 14 temperature excursions were recorded, of which 7 in 2025. The total number of affected items was 2,327, representing a total value of €55,595.6. Of these, it was possible to avoid the waste of 1,722(74%), corresponding to €40,652, and 605(26%) were eliminated, with a total of €14,943.6. The CRB occurred due to anomalies in the power supply to the equipment 80%(12) and refrigerator breakdown 20%(3). The number of vaccines subject to CRB per month in 2024 was 257 units(U), and in 2025 it was 80U.
An analysis of the causes of CRBs reveals that they are mostly related to infrastructure, with only 20% related to equipment failures. Therefore, emergency plans for equipment must be developed. It is essential to establish preventive actions collaboratively among all professional groups involved, with an emphasis on sustainability and efficient resource management, to minimize risks and avoid significant losses.
Clinical Pharmacy Services
Ewelina Lubieniecka – Archutowska, Bogusława Szmaja, Dorota Świtkowska, Agnieszka Prusko, Magdalena Jaśkowska, Marzena Mielczarek – Kęska, Urszula Dobrzycka – Magulska, Wioletta Kaliszan
Enteral nutrition therapy plays a crucial role in the management of patients who cannot meet their nutritional needs orally. Besides providing essential nutrients, enteral feeding access often serves as a route for drug administration, which requires specific knowledge about drug compatibility and pharmacotherapy safety among healthcare professionals.
The aim of this project was to improve the safety and effectiveness of pharmacotherapy administered through enteral feeding access at the University Clinical Centre in Gdańsk (UCC).
Based on literature review and institutional experience, the main challenges identified were related to the selection of appropriate medicines and pharmaceutical forms, as well as to the preparation and administration techniques used by nursing staff. To address these issues, several measures were implemented within UCC to enhance pharmacotherapy safety in patients with artificial enteral access.
A procedure titled “Principles of Administering Medicinal Products to Patients Receiving Enteral Nutrition via Feeding Tube or Gastrostomy” was developed and implemented. Within the hospital information system (Clininet), a dedicated list of medicines that must not be crushed or administered via enteral routes was introduced and made visible to physicians and nurses to support safe prescribing. Clininet also allows physicians, nurses, and dietitians to request pharmacotherapeutic consultations from hospital pharmacists. Pharmacists analyze and, when necessary, modify patients’ therapy. Medicines suitable for administration through enteral access were added to the hospital formulary, enabling physicians to choose formulations appropriate for crushing or alternative routes of administration. The hospital pharmacy introduced the so-called “Crushing Factory” – a centralized service where pharmacists prepare R.PEG-labeled medicines in safe forms and doses for enteral administration. Each administration is recorded in the patient’s medical documentation.
The implemented system led to:
• fewer prescribing and administration errors
• reduced drug loss and preparation mistakes
• fewer interactions and adverse effects
• compliance with accreditation standards for medication safety
• lower treatment costs and fewer pharmacological interventions
• reduced nursing workload and improved efficiency
Expand staff education on enteral pharmacotherapy, standardize training materials, monitor outcomes, introduce patients pharmaceutical discharge summaries and implement solutions hospital -wide to improve safety and continuity of care.
Patient Safety and Quality Assurance
Pinzon Garcia, Viviana Andrea
Fajardo Escolar, Angelica Paola
Since implementing the Opioid Stewardship Programme in 2018, we have improved the management of morphine and hydromorphone in our hospital. This has not only reduced medication waste, but also created a hospital culture that recognises the importance of standard single-dose in ensuring medication safety. Based on this, we extended the programme to include other controlled medicines, after identifying the need to limit the use of vials and ampoules of fentanyl, remifentanil and ketamine considering the available commercial presentations and the probability of using these products on multiple patients without maintaining their sterility.
We extended the coverage and monitoring of the unit-dose system to include other controlled medications apart from morphine and hydromorphone, through interdisciplinary collaboration between the Anaesthesia and Pharmacy Departments, with the aim of reducing waste and the risk of misuse at San Ignacio University Hospital, a high-level hospital in Bogotá, Colombia.
As part of the annual Pharmacy and Therapeutic Committee operative plan, the pharmacy and anaesthesia departments evaluated the risks in the medication order cycle of opioids and other controlled medications, defining strategies using an improvement cycle model. We assessed the feasibility of preparing unit doses of these medications, as well as the storage, preservation conditions and logistics of medication inventory. We deployed the strategy through staff training, mainly in operating rooms, intensive care and resuscitation, and established a follow-up of consumption and adherence, records of remnant disposal, cases of naloxone use and events reported to the pharmacovigilance programme.
The average proportion of standard single-dose prescriptions in 2025 was 74% for hydromorphone, 77% for morphine, 84% for fentanyl and 50% for remifentanil. Through our compounding center, we prepared 143,854 doses of these medications in 2024 and 78,421 from January to August 2025. The inventory write-off percentage due to expiration was 1.06% in 2024 and 0.38% in the first eight months of 2025. The percentage of hospitalised patients who received naloxone was 0.20 in the first semester of 2024 and 0.17 in the first semester of 2025.
Conducting interdisciplinary rounds in services to identify on-site adherence to implemented practices and supportting Human Talent, maintaining the improvement cycle process.
Patient Safety and Quality Assurance
Arce Sánchez, M; Álvaro Alonso, EA; Barrueco Fernández, N; Prieto Román, S; López Guerra, L; Sánchez Lorenzo, M; Flox Benítez, MP; Escobar Rodríguez, I.
Accurate weighing of raw materials(RM) is a fundamental step in ensuring the quality and safety of compounding in a pharmaceutical laboratory(PL).
Implement the use of standard masses(SM) to ensure that RM weighings performed in the PL analytical balance are as accurate as possible.
1.Balance employed is class I, with special accuracy, precision 1mg, and weighing range 10mg-220g. For this reason, E2 SM were purchased in accordance with the classification of the International-Organisation-Legal-Metrology(OIML). SM were calibrated by a laboratory accredited by the National-Accreditation-Entity(ENAC), stored under the same conditions as the balance, and handled according to manufacturer’s instructions.
2.A sensitivity test was performed to measure accuracy. The USP and chapter of the European-Pharmacopoeia, establish that the SM must be between 5% and 100% of the maximum weighing capacity of the balance. The test is satisfactory when the result obtained is within 0.1% of the nominal value(control-limit). An alert-limit was also establish(calculated as half control-limit).
3.A record form, standard-operating-procedure(SOP) and working circuit were designed. Before weighing RM, the pharmacy technician(PT) must verify leveling and internal calibration; weigh the selected SM, and record the result.
4.If weight is outside any limits, repeat internal calibration and weigh again. If it remains outside the alert-limit, the balance can be used, but the pharmacist must be notified to request external calibration. If it exceeds the control-limit, the balance cannot be used, and external calibration must be requested while another balance is employed.
SM acquired were: 10mg,20mg,20g,50g, and 100g. Those chosen to perform the sensitivity test were 20g and 100g(9.09% and 45.45% of maximum weighing balance capacity).
The range defined for 20g SM was 20g±20mg. Control-limit was 20g±10mg(19.990g-20.010g) and alert-limit was 20g±5mg(19.995g-20.005g).
The range defined for 100g SM was 100g±100mg. Control-limit was 100g±50mg(99.950g-100.050g) and alert-limit was 100g±25mg(99.975g-100.025g).
Since it was implemented in January-2025, all weighings have remained within the range.
The use of SM has shown to be a satisfactory circuit in ensuring the accuracy of the weighing of RM, used in the preparation of pharmaceutical compounding, thereby guaranteeing their safety and quality. This circuit could be established in other pharmacy departments.
Patient Safety and Quality Assurance
Javier Mata Alonso, Paula Ruiz Briones, Carlos Jiménez Villarón, Andrés Prado Lozano, Gonzalo Domínguez Chaparro, David Samitier Samitier, Juan Manuel Montes Gómez, Félix García Moreno, Sagrario Pernía López, Ana Herranz Alonso, María Sanjurjo Sáez
Concomitant use of ophthalmic drugs and contact lenses (CL) is frequent in clinical practice. However, product data sheets usually provide limited or unspecific guidance regarding compatibility. This information gap may lead to inappropriate use, discomfort, or ocular toxicity. Pharmacists can play a key role in ensuring safe use through structured, evidence-based counselling. This initiative was developed to identify existing safety gaps and to establish practical recommendations for clinical decision-making.
A review was conducted of ophthalmic drugs authorised and marketed in Spain to determine available information on their compatibility with CL. The objective was to compile regulatory data, identify inconsistencies, and design a reference framework of recommendations for pharmacists advising patients who use CL and require topical ocular treatment.
Data were obtained from the CIMA database (Spanish Medicines Agency). Among 301 registered eye drops, 186 were authorised and marketed. Products containing benzalkonium chloride (BAK) were excluded due to known incompatibility. The remaining 96 formulations (52 unique presentations) were reviewed using technical data sheets (sections 4.4 and 6.1) and compared with evidence from clinical guidelines and major ophthalmology literature. Information was synthesised into practical counselling recommendations.
Most data sheets lacked clear guidance. Three patterns were identified: no mention of CL, a generic 15-minute delay, or explicit contraindication. Only two products (bilastine 6 mg/mL and sodium chloride 0.9%) explicitly allowed CL use. Based on pharmacological class, evidence-based recommendations were developed to guide pharmacists in advising patients on safe CL use with ophthalmic drugs.
This practice model is ready to be implemented in hospital pharmacy services. Future steps include incorporating the recommendations into clinical protocols, developing patient information materials, and collaborating with ophthalmology departments to enhance safety and consistency in pharmaceutical counselling.
Production and Compounding
K. Koch, The Pharmacy of the capital region of Denmark, Quality, Herlev, Denmark
R. Højmark, The Pharmacy of the capital region of Denmark, non-sterile production, Herlev, Denmark
L.R. Duckert, The Pharmacy of the capital region of Denmark, non-sterile production, Herlev, Denmark
T. Schnor, The Pharmacy of the capital region of Denmark, production, Herlev, Denmark
There is an interest in implementing more safe, affordable, and sustainable treatment methods for patients for whom a personalized approach is beneficial. These treatments can be expensive and associated with patient safety and compliance issues. For the pediatric population, many medications are not available in appropriate form or dose and therefore is being manipulated before administration. Extemporaneous oral solutions often have a limited shelf life and bad physical properties or undesirable excipients.
Patients with impaired renal function or need for accurate dose adjustments are also expected to benefit from 3D-printed orally disintegrating tablets (OTDs).
The initial steps necessary before implementing 3D-printing for manufacturing personalized ODTs has been identified and completed. The clinical advantages and barriers of the personalized treatment has been discussed interdisciplinary and the new dosage form has been risk evaluated in dialogue with the competent authority. As a result, the best suited technology has been identified.
The European marked has been searched for technologies suitable for extemporaneous personalized production in hospital pharmacies. 3D-printed OTDs was identified as most easily implemented both concerning technology, GMP and patient acceptance.
A dialogue about risks and benefits regarding 3D-ptinted ODTs was initiated with the hospital staff. Risks identified concerned the number of drugs available for 3D-printing, the need for stability testing and resistance from authorities. Benefits like flexibility, just-in-time preparation and patient safety was identified.
A meeting was held with the competent authority, to establish the level of validation, documentation and analysis needed on the final product and starting materials.
The necessary steps to get started have been identified and completed. Risks and benefits were assessed, and the decision about implementing 3D-printed ODTs was made. An equipment that is reliable and automated has been sourced.
An API for the initial manufacture was selected, combining clinical relevance and adequate physical properties.
Ink/matrix for the 3D-printer was evaluated and found safe for medicines for children. The matrix is manufactured according to GMP.
A regulatory framework has been agreed upon with the competent authority.
Validation of the equipment and printing of the first ODTs to be used in the clinic.
