Radiopharmacy

Selection and definition of research plans that will allow students to develop essential skills for planning and implementation of research work or bibliographic revision.

• Curricular unit to standardize knowledge in the field of pharmaceutical technology, designed to provide students with basic and fundamental knowledge of the development, formulation, preparation, control and stability of medicines.
• Provide knowledge of the particularities of parenteral dosage forms, namely the guarantee of their sterility.
• To know and justify the specificity of the control of sterile liquid pharmaceutical forms Knowledge of relevant Pharmacopoeias and Guidelines for drug quality assurance.
• Motivate and enable participants to outline the rational development of medicines and maintenance of their quality throughout their shelf life.
• Knowledge of the specificities of work in an aseptic environment.
• Ability to differentiate the pharmacotechnical tests described in the Pharmacopoeias according to the type of drug product and its appropriate application.
• Ability to carry out pharmacotechnical control tests in pharmaceutical forms, in particular parenterals, according to European Pharmacopea.

• Knowledge of the European Medicines Registration System.
• Knowledge of the various European agencies, drug product approval mechanisms and referral procedures.
• European legislation: specific regulations and directives.
• ICH and Quality Guidelines
• Differentiation of the different possible types for new drugs products.
• Train students in researching guidelines for writing dossiers.
• Acquisition of basic knowledge about radiopharmaceutical legislation.
• Knowledge of pharmaceutical documentation supporting a new marketing authorization application.
• Pharmaceutical development (Q8).
• Construction of a prototype of a radiopharmaceutical product dossier.

The student must acquire fundamental knowledge about the production, quality control and distribution of radionuclides and radiopharmaceuticals in centralized radiopharmacies and production units. Fundamental concepts related to the planning and operation of infrastructures as well as the use of radiopharmaceuticals in research and drug development will be discussed.

The curricular unit of Hospital Radiopharmacy aims to train professionals with knowledge, skills and competences for a professional performance of excellence, in the scope of activities practiced in the area of Hospital Radiopharmacy within a Clinical Service of Nuclear Medicine, allowing trainees to assume responsibility for the production and quality control of radiopharmaceuticals. The syllabus integrated in Hospital Radiopharmacy should allow the acquisition of theoretical and practical concepts in terms of pharmaceutical technology applied to the preparation and handling of radiopharmaceuticals, provide knowledge in terms of National and European Regulations, including Good Manufacturing Practices. This curricular unit should also promote knowledge in terms of quality control and quality assurance procedures for radiopharmaceuticals.

To provide the students with knowledge and cognitive tools that will allow them to identify the main d- and f-transition metals with relevance for medical applications, namely for nuclear imaging (PET and SPECT) and systemic radiotherapy. The student will be acquainted with the knowledge of the coordination chemistry of these metals and should be able to understand the design of bifunctional chelators suitable to stabilize different metallic centres and optimize the pharmacokinetic properties and biological properties of the respective radiocomplexes. It is also expected that the students will identify which are the main physico-chemical properties of metal complexes (e.g., emission of ionizing radiation, paramagnetic or luminiscent nature of the metallic centre) determining their medical use, as well as the advantages and limitations of combining such properties in a single chemical entity within the development of multifunctional metal-based compounds for imaging and theranostics.

The student should be able to:

• account for fundamental concepts of radiation.
• understand the use of radioactive nuclides in nuclear medicine.
• have knowledge about the use of labelled target molecules in clinical diagnostics, medical research, and drug development.
• have expertise in the appropriate methods of radiolabelling.
• synthesise target molecules labelled with radionuclides.
• isolate and analyse the radiopharmaceuticals.

The aim of this curricular unit is to provide students with solid knowledge of the physics and radioprotection concepts relevant to radiopharmacy practices, namely on radioisotope production and physics underlying diagnostic imaging and therapeutic techniques in nuclear medicine. It establishes bridges between nuclear and particle physics, the detection and use of radiation as an imaging agent and radioprotection principles. It transmits the intellectual mechanisms of understanding and rigour underlying the scientific method that so clearly appear in the field of physics, along with the notions of engineering inherent in the adopted technological solutions and their integration as a whole.

• Get confident about the Quality Assurance system.
• Good Manufacturing Practices in the Pharmaceutical Industry.
• Application of GMP to the particular case of radiopharmaceuticals.
• Acquire knowledge to prepare internal and external inspections.
• Know the GMP certification system.
• Preparation of a Quality Master Plan.

• To understand the tracer principle and its implications in Medicine.
• To have basic knowledge of the synthesis of PET and SPECT radiopharmaceuticals.
• To be familiar with the principles of designing relevant molecules for imaging in biomedicine applications.
• To have a good comprehension of the basic principles for biological and physiological functions necessary for medical applications.