PHARMACEUTÄ°CAL BÄ°OTECHNOLOGY
Third Cycle Programmes
(Doctorate Degree/Doctor of Fine Arts)

D.1. General Information about Program

Pharmaceutical Biotechnology Doctoral 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, education-training, research--development and knowledge management that are necessary in the life cycles of biotechnology derived biological medicinal products and their combination products including their manufacturing, quality assurance, quality risk management, risk based approach in regulatory affairs, clinical investigations and therapeutic uses. Pharmaceutical Biotechnology is built on the fundamentals of pharmaceuticals and pharmacy 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 including regenerative advanced therapy medicinal products/medicines/products.

Pharmaceutical Biotechnology Doctoral Program includes theoretical and practical education in Turkish at the doctoral 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 combination products.

The education program of the students attending Pharmaceutical Biotechnology Doctoral Program who graduated from the programs other than 5-year program of the Faculty of Pharmacy or Pharmaceutical Biotechnology Master of Science Program is planned in line with the student's requests and the opinions of the advisor in order to enable them to attain the expected competence, taking into account the undergraduate degrees of the students.

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, volt ohmmeters 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

Doctorate

D.3. Level of Qualification

QF-EHEA: 3
EQF-LLL: 8

D.4. Provisions for Registration

Graduates of Pharmaceutical Biotechnology Master?s Degree Program, graduates of the Faculty of Pharmacy (5-year Program), and graduates of the Faculty of Medicine  and the Faculty of Veterinary Medicine , who meet the conditions for application to Hacettepe University Institute of Health Sciences Graduate Program, are accepted to the Doctoral Program of Pharmaceutical Biotechnology  Department.     

The program accepts students from the disciplines other than Pharmacy, and for these students, scientific preparation may be required and special conditions may apply on the basis of the respective requests of the doctoral student, recommendations of the advisor, and requirements as per the Pharmaceutical Biotechnology Doctoral Program competencies.

Documents required for application to the Pharmaceutical Biotechnology Doctoral Program, 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 Doctoral Program comprises courses, proficiency examination, thesis proposal, thesis study and thesis defense in accordance with the relevant articles and provisions of the Hacettepe University Graduate Education-Training and Examination Directive which are accessible via the links below.

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

In order to obtain the doctoral degree in Pharmaceutical Biotechnology in accordance with the relevant articles and provisions of the Hacettepe University Guidelines for Postgraduate Education and Training and Exams, the candidate must meet the conditions specified for doctoral proficiency, attend doctoral courses of at least 24 credits (at least 120 ECTS [European Credit Transfer System] credits), pass proficiency exam and complete doctoral thesis, and earn a total of 240 ECTS credits.

In the course stage of the Pharmaceutical Biotechnology Doctoral Program, 13,3 % of the 90 ECTS credits must be earned from the compulsory courses. The remaining 86,7 % of the ECTS credits can be earned from the elective courses that would help student attain competency in the program and be beneficial in the thesis study, or elective courses of the other programs related with Pharmaceutical Biotechnology. Courses to be taken out of the program can be selected among other programs provided in Hacettepe University Institute of Health Sciences or graduate courses provided by our university or by other universities. Among elective courses, selecting at least one Biostatistics course from the Biostatistics Graduate Program provided by Hacettepe University Institute of Health Sciences is essential, and suggested to comply with the criteria of national doctoral competency. Students who start PhD program directly in the Pharmaceutical Biotechnology Doctotal Program are required to take "SBE 601 Research Methods, Research and Publication Ethics" course as an elective course organized by the Institute of Health Sciences according to their undergraduate degree. The selection of courses is conducted under the guidance of the advisor, considering the previous education of the student, thesis subject, and the fields that the student wishes or needs to be trained on.

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 education, Pharmaceutical Biotechnology Doctoral 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 Pharmaceutical Biotechnology Department is regulated by the Directive of Hacettepe University Graduate Education, Training and Examination 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

Providing the knowledge at the doctoral level required for the research, development, design, production, quality assurance, quality control, regulatory affairs, clinical investigations and therapeutic applications of pharmaceutical biotechnology based biological drugs (biological medicinal products), medical devices, combination products and advanced technologies related to them remains among the most important objectives of the program.

The objectives of Pharmaceutical Biotechnology Doctoral Program:

• Gaining the required theoretical and experimental knowledge and skills in characteristics, production technologies, quality assurance, quality-risk management, risk-based regulatory affairs, clinical trials, distribution and follow-up processes and associated national and international legislation about Pharmaceutical Biotechnology derived drugs (medicinal products), biological medicinal products, recombinant protein drugs, immunopharmaceuticals (vaccines), biosimilar medicinal products, advanced therapy medicinal products (ATMP) (somatic cell therapy medicinal products, gene therapy medicinal products, tissue engineered medicinal products, combined ATMP), stem cell derived drugs, personalized medicines, regenerative drugs, orphan drugs, medical devices and combinations products;

• Using the gained knowledge on Pharmaceutical Biotechnology in favor of human and public health in accordance with legal, ethical and bioethical principles, and having the skills of scientific thinking, independent and original research and innovative drug-product development;

• Raising scientist having doctoral degree in Pharmaceutical Biotechnology who can work in Pharmaceutical Biotechnology, Pharmaceutics, drug, medical device, vaccine, ATMP, stem cell-derived drugs and in multidisciplinary fields related with Pharmaceutical Biotechnology, and who can fill academic positions in the universities, Turkish Medicine and Medical Device Agency, Turkish Institution of Public Health, the Republic of Turkey Social Security Institution, Turkish Standards Institution, pharmaceutical industry, biotechnology industry, hospitals, cell, stem cell, gene, advanced therapy and advanced technologies research and development centers, contract research organizations related with clinical investigations, contract manufacturing organizations and notified bodies for medical devices, who can take charge and responsibility in the production, quality assurance, quality control, auditing, implementation, licensing, pharmacovigilance, biovigilance, vigilance, technology assessment and decision making processes in reimbursement.

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, licensing, 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

D.14. Profile of the Programme

The courses in Pharmaceutical Biotechnology Doctoral Program are provided in autumn and spring semesters considering the changes in the semester of admission of the student to the program. The student must earn 120 ECTS credits (42 ECTS credits (35%) from compulsory courses and 78 ECTS credits (65%) from elective courses) from the courses and 120 ECTS credits from the thesis, and must be successful in related courses to complete the program.

In the context of elective courses, the student can take courses from other programs. The selection of elective courses must take into consideration the learning outputs in Pharmaceutical Biotechnology Doctoral Program. All Compulsory and elective courses in the Pharmaceutical Biotechnology Doctoral Program and their credits are shown under the title of Course Structure Diagram with Credits.

D.15. Examination Regulations, Assessment and Grading

Measurement, evaluation and scoring criteria for each course are explained in the section titled Course Structure Diagram with Credit prepared by the lecturer(s). Exams and achievement scores 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

In order to obtain the Pharmaceutical Biotechnology Doctoral Degree in accordance with the relevant articles, provisions and updates of the Hacettepe University Graduate Education, Training and Examination Directive, which is accessible via the link below, the candidate must meet the conditions specified for doctoral proficiency, attend courses of at least 24 credits (at least 120 ECTS credits), pass proficiency exam and complete doctoral thesis, and earn a minimum of 240 ECTS credits at the end of the program.

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)

Fax: +90 312 311 47 77

Address: Hacettepe University, Faculty of Pharmacy

              Pharmaceutical Biotechnology Department Head

             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