PHARMACEUTÄ°CAL BÄ°OTECHNOLOGY
Second Cycle Programmes
(Master's Degree)

D.1. General Information about Program

Pharmaceutical Biotechnology Master of Science Program has served as the pioneer in the establishment of the Department of Pharmaceutical Biotechnology in 1993 and in the beginning of postgraduate training in the field of Pharmaceutical Biotechnology within the Faculties of Pharmacy in our country.

Scientific scope of the Pharmaceutical Biotechnology encompasses technologies, advanced technologies and tools, research and development, education and training, and knowledge management that are necessary in the life cycles of pharmaceutical biotechnology derived biological medicinal products and combination products including their manufacturing, quality assurance, quality risk management, risk based approach in regulatory affairs, clinical investigations and therapeutic applications. Pharmaceutical Biotechnology is built on the fundamentals of pharmaceuticals and pharmaceutics and it requires multidisciplinary knowledge and experience as the most rapidly evolving area of biotechnology, contributing to human and public health and creating high value-added in the national economy through introduction of innovative drugs and products and regenerative advanced therapy medicinal products/medicinal prıducts.

Pharmaceutical Biotechnology Master's Program includes theoretical and practical education in Turkish at the Master's level on the characteristics, production technologies, quality assurance, risk-based licensing, distribution and follow-up processes, clinical research, therapeutic applications, national and international regulations, ethical and bioethical principles of pharmaceutical biotechnology based biological medicinal products (recombinant DNA technology derived protein drugs, monoclonal antibodies (MoAb), biosimilar drugs), immunopharmaceuticals (vaccines), stem cell-derived drugs, advanced therapy medicinal products (ATMP) (somatic cell therapy medicinal products, gene therapy medicinal products, tissue engineered medicinal products, combined ATMP), regenerative advanced therapy medicines and products, biological drug-medical device, biological drug-drug combinations products.

In order to enable the students, accepted to Pharmaceutical Biotechnology Master Program, to gain expected competence, the field of bachelor's degree is taken into consideration for each student, and the teaching plan is prepared in the direction of the student's requests and the recommendations of the advisor.

The students who register the program will be granted access to the infrastructure and facilities of research and cell culture laboratory of the Pharmaceutical Biotechnology Department Our laboratory is equipped with facilities such as horizontal and vertical electrophoresis systems for protein and gene analysis, microplate fluorescence spectrophotometer, UV spectrophotometer, centrifuge and biosafety ultracentrifuge systems, bacteria and mammalian cell culture facilities (shaking incubators, carbon dioxide incubator, laminar flow microbiological safety cabinet, water bath and cooling systems, invert phase contrast-fluorescent microscope with digital imaging systems, voltohmmeters with conventional and HTS electrode system), gel imaging device, heat-jacketed extrusion device, high shear mixers, nanosizer particle size analyzer, polarizing invert phase contrast microscope and imaging system and other small laboratory devices.

D.2 Qualification Awarded

Master's Degree

D.3. Level of Qualification

QF-EHEA: 2
EQF-LLL: 7

D.4. Provisions for Registration

Students graduated from the Faculty of Pharmacy; Biology, Molecular Biology and Chemistry Departments of the Faculty of Science; Chemical Engineering, Genetic Engineering, and Bioengineering Departments of the Faculty of Engineerin; Faculty of Medicine and  Faculty of Veterinary Medicine are accepted to the Pharmaceutical Biotechnology Master?s Degree  Programme.

For students who are accepted from the disciplines other than the Faculty of Pharmacy, scientific preparation may be required and special conditions may apply on the basis of the respective requests of the student, recommendations of the advisor, and requirements as per the program competencies.

Documents required for application to the Pharmaceutical Biotechnology Master?s Degree  Programme, exam, exam date and other conditions are determined and implemented by the relevant articles, provisions and updates of the Hacettepe University Graduate Education, Training and Examination Directive.

Hacettepe University Graduate Education, Training and Examination Directive: http://www.saglikbilimleri.hacettepe.edu.tr/Sabil/yonetmelik13.pdf

To have ALES (SAY / EA) score type and ALES and Foreign Language base score determined by the Health Sciences Institute Board and approved by the Hacettepe University Senate http://www.saglikbilimleri.hacettepe.edu.tr/en/menu/ales_foreign_language_scores-252

D.5. Qualification Requirements and Regulations

Pharmaceutical Biotechnology Master?s Program comprises courses, thesis proposal, thesis study and thesis defense in accordance with the relevant articles, provisions and updates of the Hacettepe University Graduate Education, Training and Examination Directive  which are accessible via the links below.

Student must earn 120 ECTS credits, which correspond to 21 national credits, in order to complete Pharmaceutical Biotechnology Master?s Programme.  Of a total of 60 ECTS credits to be earned from the courses, 31,67 % must be gained from compulsory courses and the remaining 68,33 % should be earned from the elective courses and/or elective courses from Hacettepe University Institute of Health Sciences and/or from other Institutes that would contribute to the education of the student or to the thesis study in the field of Pharmaceutical Biotechnology

Hacettepe University  Graduate Education, Training and Examination Directive: http://www.saglikbilimleri.hacettepe.edu.tr/Sabil/yonetmelik13.pdf

D.6. Specific Arrangements for Recognition of Prior Learning

In order for the applications to be accepted with regards to the recognition of prior learning, Pharmaceutical Biotechnology Master's Program should have a vacancy, and conformity assessment should have been made by the Academic Board of the Department of Pharmaceutical Biotechnology.

Admission and adaptation of students found to be eligible for transfer by the Academic Board of the Department of Pharmaceutical Biotechnology is regulated by the relevant articles and provisions of Hacettepe University Graduate Education, Training and Examination Directive and is finalized by the decision of the Health Sciences Institute Board of Directors.

Hacettepe University Graduate Education, Training and Examination Directive: http://www.saglikbilimleri.hacettepe.edu.tr/Sabil/yonetmelik13.pdf

D.7. Goals and Objectives

The most important objectives of the Pharmaceutical Biotechnology Master's Program are to provide the necessary knowledge and experience at the expert level required for the research, development, design, production, quality assurance, quality control , regulatory affairs, clinical investigations, therapeutic applications of Pharmaceutical Biotechnology derived biological drugs (medicinal products), combination products and advanced technologies related to them.

The objectives of Pharmaceutical Biotechnology Master's Program:

• Gaining specific knowledge, and analytic-critical thinking and independent decision making approach while solving problems encountered in the field of Pharmaceutical Biotechnology;
• Increasing the student's knowledge level and practical skills and prepare the student for the future work environment and to continue Pharmaceutical Biotechnology Doctoral Program;
• Being provided with the sufficient multidisciplinary knowledge and skills in the field of Pharmaceutical Biotechnology, being able to take charge and responsibility in areas related with Pharmaceutical Biotechnology, Pharmaceutics, drugs (medicinal products), biological medicinal products, recombinant protein drugs, monoclonal antibodies (MoAb), immunopharmaceuticals (vaccines), biosimilar drugs, advanced therapy medicinal products (ATMPs) (somatic cell therapy medicinal products, gene therapy medicinal products, tissue engineered medicinal products, combined ATMP), and stem cell-derived drugs, personalized medicines, regenerative drugs, orphan drugs, medical devices and combinations products; and areas related with Pharmaceutical Biotechnology;
• Raising Pharmaceutical Biotechnology Specialist who can use their educational attainments for the benefit for human and public health in accordance with legal, ethical and bioethical principles.

D.12. Occupational Profiles of Graduates with Examples

Students completed our Pharmaceutical Biotecnology Graduate Programs are employed in the universities as academic staff, R&D, quality assurance, production, quality control, microbiology and licensing of pharmaceutical biotechnology derived drugs and products in the pharmaceutical industry, Turkish Medicine and Medical Device Agency, the Republic of Turkey Social Security Institution and private establishments related to pharmaceutical consultancy.

There is profound demand in our country for specialized and trained human resources in the field of Pharmaceutical Biotechnology. Graduates are employed with various responsibilities under the title of Pharmaceutical Biotechnology Specialist in multidisciplinary fields related with Pharmaceutical Bioechnology, pharmaceuticals, pharmaceutics, medical devices, advanced therapy medicinal products, at academic positions in the universities, Turkish Medicine and Medical Device Agency, Turkish Institution of Public Health Republic of Turkey Social Security Institution, Turkish Standards Institution, Turkish Patent Institute, pharmaceutical industry, biotechnology industry, hospitals, research and development centers related to cell, stem cell, gene and advanced therapies and advanced technologies, contract research organizations related to clinical investigations, contract manufacturing organizations, notified bodies for medical devices, and take charge responsibility in the production, quality assurance, quality control, auditing, implementation, licensing, distribution, monitoring, pharmacovigilance, biovigilance,vigilance, technology assessment and decision making processes in reimbursement depending on the previous educations.

D.13. Access to Further Studies

QF-EHEA: 3
EQF-LLL: 8

D.14. Profile of the Programme

All courses in Pharmaceutical Biotechnology Master's Program are offered in spring and autumn semesters. The structure of the teaching program, compulsory and elective courses in the program, their credits and other relevant information can be found under the title of Curriculum.

The student must earn a minimum of 60 ECTS credits (20% from compulsory courses and 80% from elective courses) from the courses and 60 ECTS credits from the thesis, and must be successful in related courses to complete the program. In the context of elective courses, student can take courses from other programs. The selection of elective courses must take into consideration the learning outputs in Pharmaceutical Biotechnology Master's Degree Program.

D.15. Examination Regulations, Assessment and Grading

Measurement and evaluation methods for each course in Pharmaceutical Biotechnology Master Program are prepared by the lecturer(s) and explained in the ‘Course Structure Diagram with Credits' . Evaluation of the exams and pass marks are set in accordance with the relevant articles and provisions of the Hacettepe University Graduate Education, Training and Examination Directive .

Hacettepe University Graduate Education, Training and Examination Directive: http://www.saglikbilimleri.hacettepe.edu.tr/Sabil/yonetmelik13.pdf

D.16. Graduation Requirements

A student must earn a minimum of 60 ECTS credits (20% from compulsory courses and 80% from elective courses) from the courses and 60 ECTS credits from the thesis and must be successful in related courses to complete Pharmaceutical Biotechnology Master of Science Program in accordance with the relevant articles and provisions of the Hacettepe University Graduate Education, Training and Examination Directive which are accessible via the link below.

Hacettepe University Graduate Education, Training and Examination Directive: http://www.saglikbilimleri.hacettepe.edu.tr/Sabil/yonetmelik13.pdf

D.17. Education Type

1. Full Time Education

D.18. Programme Director

Prof. Dr. Betül ARICA YEGİN

Pharmaceutical Biotechnology Department Head

e-mail: barica@hacettepe.edu.tr

Tel: +90 (312) 305 12 41 / 21 68 (Secretary)

        +90 (312) 310 15 24 (Secretary)

        + 90 (312) 305 43 70 (Direct line)

        + 90 (312) 305 23 42 (Direct line)

Fax: +90 312 311 47 77

Address: Hacettepe University, Faculty of Pharmacy

              Pharmaceutical Biotechnology Department

              06100 Sıhhiye - Ankara

Department Web Address:

http://www.eczacilik.hacettepe.edu.tr/index.php?option=com_content&view=article&id=43%3Afarmasoetik-biyoteknoloji-anabilim-dal&catid=19&Itemid=10

Programme Web Address:

http://www.saglikbilimleri.hacettepe.edu.tr/programlar.html