Course on Medical Isotope Regulations
Online course of 300 h in Medical Isotope Regulations. 6 modules covering Directive 2013/59/Euratom (medical exposures), Directive 2001/83/EC (medicinal products for human use) and OLINDA/EXM (internal dosimetry). Dedicated tutor and enrolment open.
Course on Medical Isotope Regulations — studying from Malta
Malta has no nuclear power generation, and its nuclear engineering relevance lies mainly in radiation protection, safeguards awareness, medical and industrial radiation use, and regulatory oversight of radioactive materials. The Malta Radiation Protection Department and the Health Directorate oversee the use of radiation in hospitals, research and industry. Engineers may find roles in medical physics support, radiological monitoring and compliance. The sector is largely confined to applied and regulatory work rather than fuel cycle activity.
Fees for Malta: €644 (Euro), with instalments and employer sponsorship available.
Relevant bodies in Malta
Typical roles
Questions from Malta
Is there a professional route in Malta for nuclear engineering, and is SEIUM's qualification recognised?
Malta does not operate nuclear power plants, so nuclear engineering careers there are limited, and roles are more likely in regulation, consultancy or international work. SEIUM Institute's qualifications are private, not official state degrees, and are not accredited by any national body. Recognition is decided by employers or the relevant regulatory body, so verify this before enrolling.
What employment could this training lead to in Malta?
Given Malta has no nuclear power generation, local opportunities are few and would mostly sit within consultancy, international organisations or firms working abroad. Employers in these roles set their own qualification requirements, and a private online qualification may or may not be accepted. Reviewing job requirements and speaking with employers will show how the training would be viewed.
Can I study this from Malta without relocating, and how is the workload structured?
Yes, the programmes are 100% online, taught in English and suitable for study from home, so you do not need a student visa. Master's programmes total 1,900 hours, postgraduate diplomas 800 hours and specialist courses 300 hours. Each student has an assigned technical tutor, and fees are payable in instalments, with possible employer sponsorship.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Describe the main medical radioisotopes and their diagnostic and therapeutic uses.
Interpret the regulatory framework for radiopharmaceuticals as medicinal products.
Apply radiation protection requirements in nuclear medicine departments.
Analyse the production and transport chain of short-lived radioisotopes.
Assess international policies on the security of radioisotope supply.
Identify the quality requirements applicable to a radiopharmacy.
Prepare a regulatory dossier for a medical radioisotope.
Who it's for
- Radiopharmaceutical regulatory affairs officer looking to specialise in Medical Isotope Regulations.
- Radiopharmacist looking to specialise in Medical Isotope Regulations.
- Nuclear medicine radiation protection specialist looking to specialise in Medical Isotope Regulations.
- Radiopharmacy quality assurance manager looking to specialise in Medical Isotope Regulations.
- Radioisotope supply consultant looking to specialise in Medical Isotope Regulations.
- Radioactive material transport technician looking to specialise in Medical Isotope Regulations.
- Engineering or science graduates looking to move into nuclear medicine.
What you'll work with
- Directive 2013/59/Euratom (medical exposures)
- Directive 2001/83/EC (medicinal products for human use)
- EU Good Manufacturing Practice, Annex 3 (radiopharmaceuticals)
- Spanish Royal Decree 601/2019 (justification and optimisation in medical exposures)
- European Pharmacopoeia (radiopharmaceutical monographs)
- IAEA SSG-46 (radiation protection in medical uses)
- IAEA SSR-6 (Rev.1) (transport of radioactive material)
6 modules · 300 h
1.1Diagnosis: Tc-99m, F-18 and Ga-681.2Therapy: I-131, Lu-177 and Ra-2231.3Theranostics1.4The Mo-99 supply chain1.5Production reactors: HFR, BR2 and SAFARI-11.6Cyclotrons and generators1.7The 2009-2010 supply crisis1.8Conversion to low-enriched uranium1.9The NEA High-Level Group HLG-MR1.10Case study: map of Mo-99 supply in Europe
2.1Directive 2001/83/EC and radiopharmaceuticals2.2European Pharmacopoeia and monographs2.3Good Manufacturing Practice: Annex 32.4Radiopharmaceuticals in Spain: RD 479/19932.5Clinical trials with radiopharmaceuticals2.6Marketing authorisation2.7The European Medicines Agency2.8FDA and 21 CFR Part 2122.9Quality control2.10Workshop: requirements for a PET radiopharmaceutical
3.1Medical exposures in Directive 2013/593.2Justification and optimisation3.3Diagnostic reference levels3.4Worker protection3.5Patient discharge after therapy3.6Pregnancy and breastfeeding3.7Hospital radioactive waste3.8Authorisation of radioactive facilities3.9RD 1029/2022 and RD 601/20193.10Practical exercise: discharge criteria after I-131 therapy
4.1Licensing of production reactors4.2Cyclotron authorisation4.3Uranium targets and waste management4.4Security of sources4.5Transport under SSR-6 and Type A packages4.6Air transport and IATA rules4.7Denial of shipments4.8Customs and half-lives4.9Production of Lu-177 and Ac-2254.10Case study: transporting a Mo-99/Tc-99m generator
5.1European Observatory on the Supply of Medical Radioisotopes5.2The SAMIRA European action plan5.3Security of supply and cost recovery5.4Elimination of highly enriched uranium5.5Accelerator-based production5.6Access in middle-income countries5.7Pricing and reimbursement5.8Clinical research in theranostics5.9The future of supply5.10Case study: Lu-177 supply risks
6.1Selecting the radioisotope6.2Production and supply chain6.3Pharmaceutical requirements6.4Radiation protection requirements6.5Transport requirements6.6Supply risk analysis6.7Compliance matrix6.8Recommendations6.9Report and presentation6.10Final review with the tutor
How you'll learn
100% online training on the SEIUM campus, with downloadable materials, recorded classes and a dedicated technical tutor. No fixed timetable: students progress at their own pace within the intake period, making it easy to combine with work.
Each module combines theory, guided reading of the original standards and applied exercises. The software used is OLINDA/EXM (internal dosimetry), MIRDcalc, advanced Excel (supply management), SCALE (production and inventory calculations), in free, academic or trial versions. Testing is studied through real procedures, including review of radiopharmaceutical authorisation dossiers, analysis of Mo-99/Tc-99m supply chains and Good Manufacturing Practice compliance audits. Assessment is continuous for each module, plus a final capstone project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Describe the main medical radioisotopes and their diagnostic and therapeutic uses.
Interpret the regulatory framework for radiopharmaceuticals as medicinal products.
Apply radiation protection requirements in nuclear medicine departments.
Analyse the production and transport chain of short-lived radioisotopes.
Assess international policies on the security of radioisotope supply.
Where this takes you
Requirements
- No previous qualification is required.
- An internet connection and a computer able to run the programme software.
- A level of English sufficient to read technical standards.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 300 hours spread over 3 to 5 months. That is an average of 10 to 15 hours per week, compatible with a full-time job.
You will work with OLINDA/EXM (internal dosimetry), MIRDcalc, advanced Excel (supply management), SCALE (production and inventory calculations). Free, academic or trial versions are used, and your tutor will point out a free alternative where one exists.
A SEIUM Institute diploma, awarded on passing the continuous assessment and the capstone project. It is SEIUM's own qualification, not an official state-accredited degree.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the higher programme. Check the recognition policy when you enrol.
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