Hacettepe University

Definition of radiopharmacy, radiopharmacist, radiopharmaceutical and radiochemical
Importance of radiopharmacy in health area and terminology
Structure of atom, radioactivity, radioisotopes, types of radiation emission.
Classification of radiopharmaceuticals, half lives, characterization of ideal radiopharmaceuticals
Production of radioisotopes; reactor, cyclotron and generators
Biological effect of radiation
Radiation hygiene and dosimeter types
Waste management
Design of radiopharmacy laboratory
Cell internalization of radiopharmaceuticals
Radiopharmaceuticals and radioactive medical devices from pharmacopeia
Radiopharmaceuticals provided from suppliers.

Lecture: ECF 252 Radiation Protection

Semester and year: Spring (4.)

Type and Credit: Elective, 2-0-2

Content:

Lecture: ECF 349 Medical Devices, Application in The World and Turkey Status

Semester and year: Autumn (5.)

Type and Credit: Elective, 2-0-2

Content:

Definition of medical device and related terminology
United States/FDA and application related to medical devices
European Union/EMA and application related to medical devices
Classification of medical devices and related algorithm
CE label and regulations
Examples of medical devices (lens solutions, shoes inserts, neck protector, plasters, stents, brain and heart pacemaker, compression socks, surgical thread, wound dressing, surgical dressing)
Production of medical devices
Sterilization of medical devices
License applications for medical devices.

Lecture: ECF 439 Radiopharmaceuticals and Hospital Application

Semester and year: Autumn (9.)

Type and Credit: Elective, 2-3-3

Content:

Radiopharmaceuticals used in skeletal, circulatory, respiratory, excretory, neurological systems and in oncology
Preparation, clinical use and properties of these radiopharmaceuticals
Their used in scintigraphic imaging
Collaborative evaluation of the clinical cases by radiopharmacist and nuclear medicine doctors.

Lecture: ECF 446 Good Radiopharmacy Practice (GRP)

Semester and year: Spring (8.)

Type and Credit: Elective, 2-0-2

Content:

Quality, Quality Assurance System
Good Manufacturing Practice (GMP) and Good Radiopharmacy Practice (GRP)
Design of radiopharmacy laboratories
Equipments used at radiopharmacy laboratories
Particular, microbial and radioactive contamination and monitoring of these contamination and measurement required to reduce these contamination
Quality control test for radiopharmaceuticals ; radiochemical purity, radionuclidic purity
Transportation of radioactive materials
Waste management for radioactive waste
Documentation.

Lecture: ECF 545 Preparation of Licensing File for Radiopharmaceuticals

Semester and year: Autumn (9.)

Type and Credit: Elective, 2-0-2

Content:

Regulations for radiopharmaceuticals (United States of America, European Union and Turkey)
What is the concept of licensing file
Preparation of licensing file according to CTD
Required documents for radiopharmaceuticals manufacturing area
Good Radiopharmacy Practice (GRP) Guidelines for radiopharmaceuticals.

Lecture: ECF 547 Quality Control of Radiopharmaceuticals

Semester and year: Autumn (9.)

Type and Credit: Elective, 2-0-2

Content:

What is radiopharmaceuticals? Classification of radiopharmaceuticals, Principles of ideal radiopharmaceuticals
Quality, quality assurance, quality control
Quality control test for radiopharmaceuticals; physicochemical tests
Quality control test for radiopharmaceuticals; biological tests
Dose calibrators and their quality control tests
Mo/Tc generators and their quality control tests
Quality control test of some Tc-99m, radioiodine and other radionuclide labeled radiopharmaceuticals used in nuclear medicine practice.