Entry requirements

Radiation Protection and Medical Effects, 4 credit points/6 credits (6 ECTS credits), or corresponding knowledge and:

1) Accepted participant in the Master programme in Medical Nuclide Techniques

--or--

2) University degree (BSc or MSc) after at least three years of study (minimum 120 credit points/180 credits or 180 ECTS credits) in life sciences (e.g. physics, radiophysics, chemistry or biology), medicine, pharmacy, nursing, or other relevant University education.

Learning outcomes

After passed course it is expected that the student can:

-describe the basic concepts of Good Manufacturing Practice, especially those relevant for small-scale production of radiopharmaceutical compounds for use in humans

-present formal requirements from authorities on GMP for medical drugs, laws and regulations for preparation of sterile drugs

-describe the regulations for radiopharmaceuticals within the frames of clinical trials.

-describe quality control, chemical and radiochemical identity and purity

-describe microbiological quality control, aseptic production, localities, clothing etc.

-describe quality assurance, design of quality systems, risk analysis and risk assessment

-explain Good Clinical Trial Practice (GCTP) in theory and in clinical trials

-describe Audit, monitoring, internal and external inspections

-describe qualification and validation

-carry out production under GMP and preparation of monographs, standard operating procedure, SOP, batch protocols, exercise in aseptic production and presentation and analysis of protocols

Content

-Good Manufacturing Practice: definitions, requirements and historical background

-Quality assurance, quality management, design of quality systems

-Principles for documentation in GMP

Site Master File, SMF

Monographs

Protocols (production protocols, standard operating procedures, SOP)

-Quality control, chemical and radiochemical identity and purity

-Risk analysis and risk assessment

-Clinical trials

-Qualification and validation

-Introduction to basic microbiology

-Microbiological test and quality control

-Aseptic production, localities, clothing

-Audit, monitoring, internal and external inspections

-Alternative quality systems (nationally and internationally)

-Good Manufacturing Practice in clinical trials

-Exercises; production of monographs and standard operation protocol, SOP, including exercise in aseptic production

-Requirements for radiolabelled cell lines and proteins (seminar)

Instruction

Lectures, seminars and exercises/demonstrations. Course-specific web site information and education material.

Assessment

Oral examination at the end of the course. A passing grade for the entire course requires passing grade for the individual subprojects. The grades "Pass" or "Fail" are given.