Masterat - Industrie FARMACEUTICĂ

 

Master in Pharmaceutical Industry

1. Director of Study Program: Prof. dr. Ioan TOMUȚĂ
2. Duration: 2 years, 120 ECTS credits
3. Study program: full-time
4. Description:
The main objective of the study program is to train specialists for the pharmaceutical industry, a priority economic field. The Master in PHARMACEUTICAL INDUSTRY is a program of postgraduate university studies, of based on education and scientific research. The Master in Pharmaceutical Industry is a high-level study program offering theoretical and practical training of specialists with multidisciplinary grounding. The postgraduate students enrolled in this program will be able to successfully practice in the development, manufacture, analysis and evaluation of industrial drug products, thus supporting the development of Romanian pharmaceutical industry. The PHARMACEUTICAL INDUSTRY master program’s profile focuses on the scientific, technological, legislative and administrative aspects regarding of the manufacture of industrial drug products.
The students are provided with in-depth training in the fields of drug formulation, technological and analytical drug development, manufacture and quality evaluation of industrial drug products, as well as with orientation towards scientific research related to technological development, analytical development or clinical evaluation of industrial drug products. Other issues that are the preparation of the documentation required for obtaining a marketing authorization of a pharmaceutical drug product and the European regulations on Good Manufacturing Practice. In order to provide a professional training in-line with current requirements, this program was developed in close collaboration with the pharmaceutical industry. Furthermore, industry experts have been co-opted as associate teachers to give courses and lectures for students.

The course topics providing the training in the mentioned fields are:

1st Semester  
 
  1. Drug Regulatory Affairs 
  2. Experimental Research Methodology 
  3. Pharmacokinetics in Drug Development and Evaluation 
  4. Academic Ethics and Integrity 
  5. Drug Chemistry / Drug Design, Discovery and Synthesis (at choice)
 
  • 7 ECTS credits
  • 7 ECTS credits
  • 7 ECTS credits
  • 4 ECTS credits
  • 5 ECTS credits
2nd Semester
 
  1. Analytical Drug Development
  2. Pharmaceutical Drug Development 
  3. Drug Bioavailability and Bioequivalence 
  4. Industrial Drug Manufacturing I 
  5. Pharmaceutical Technology/ Biopharmaceutical Drug Manufacturing 
 
  • 6 ECTS credits
  • 7 ECTS credits
  • 5 ECTS credits
  • 7 ECTS credits
  • 5 ECTS credits
3rd Semester
 
  1. Industrial Drug Manufacturing II 
  2. Quality Assurance and Good Manufacturing Practice 
  3. Drug Quality Control 
  4. Statistics and Multivariate Experimental Data Analysis 
  5. Natural Products - from isolation to dosage forms / Pharmaceutical Technology II (at choice)
 
  • 7 ECTS credits
  • 6 ECTS credits
  • 6 ECTS credits
  • 6 ECTS credits
  • 5 ECTS credits
4th Semester  
 
  1. Intellectual Property in the Pharmaceutical Field 
  2. Dissertation Thesis Preparation 
  3. Professional Practice 
 
  • 5 ECTS credits
  • 20 ECTS credits
  • 5 ECTS credits

The course topics and the contents of the courses were established based on the theoretical and practical training needs of the personnel who works in pharmaceutical industry, as it resulted from the discussions with key persons form the top management of the Romanian pharmaceutical companies. These needs have been translated into specific objectives of the master's program and are the following:

  • in-depth knowledge of the scientific principles underlying the pre-formulation, formulation and industrial manufacture of medicinal products;
  • in-depth knowledge of European regulations in the field of development, manufacture, control and quality assurance of the medicinal product;
  • in-depth knowledge of biopharmaceutical and pharmacokinetic principles in the development and evaluation of the medicinal product;
  • in-depth knowledge of the procedures for authorizing the medicinal product for its industrial manufacture and its introduction to the market;
  • knowledge and understanding of technological processes of industrial manufacturing of medicines;
  • knowledge and understanding of methods of physical-chemical, biological and microbiological control of drugs;
  • knowledge and understanding of the Quality Assurance concept in the pharmaceutical industry.

In order to achieve a study program perfectly adapted to the current requirements of employers from the pharmaceutical industry, 5 professionals who hold a PhD degree in Pharmaceutical Sciences and work in the pharmaceutical industry, where they hold top management positions, accessed due to their experience and expertise in the field, are permanently invited, as associate teachers, to support 20-25% of the teaching activity of the courses and / or practical works / seminars.

5. Addressability:
The master's program is addressed to graduates of pharmacy, medicine, biology, chemistry, physics, engineering or mathematics, who work or wish to work in the pharmaceutical industry, in areas such as: research and development; industrial manufacture of medicines; production of active substances and excipients; drug quality control; quality assurance in the pharmaceutical industry; drug regulatory affairs; clinical studies and postmarketing surveillance; drug manufacturing management.


6. QUALIFICATION AND CAREER OPPORTUNITIES:
After graduation and validation of the final exam, the qualification of specialist in the pharmaceutical industry is obtained, with the title of master, and the following positions existing in the European Union can be occupied, according to the ESCO portal of the European Commission:

  • industrial pharmacy specialist
  • pharmaceutical quality specialist
  • industrial pharmacy consultant

OPPORTUNITIES
This master's degree program opens prospects for successful career development for:

  •  Pharmaceutical and medical professionals: pharmacists, medical doctors, veterinarians, licensed pharmacy assistants, licensed nurses who are working or want to work in the pharmaceutical industry or related fields such as cosmetics, medical devices industry, nutraceuticals industry;
  •  Professionals in the chemical, biological, physical, engineering, or graduates of other bachelor's / master's studies, who are working in the pharmaceutical industry or related fields such as the cosmetics industry, the medical devices industry, the nutraceuticals industry;
  •  Pharmacists, doctors, biologists, biochemists, physicists, chemists, chemical engineers who are working in the research and development laboratories of the pharmaceutical industry or in the development laboratories of manufacturers of raw materials for the pharmaceutical and cosmetics industry.
  •  Pharmaceutical and medical professionals who are working in the administration or in regulatory agencies in the field of medicines, medical devices or cosmetics.
  •  Specialists from any other type of company involved in related fields such as, medical devices, parapharmaceuticals, medicinal teas, biocides, detergents.

7. Teaching language: English,

8. Admission
ADMISSION METHODOLOGY
The admission is addressed to graduates of the faculties of Pharmacy and Medicine, studies with at least 300 ECTS credits, but also to graduates of the faculties of Chemistry, Biology, Physics, Engineering, Mathematics or other related fields, who have acquired at least 240 education credits before the adoption of the Bologna system, or 180 ECTS in the Bologna system (license). Given that the study program is conducted in English, only people who prove, through a certificate of language proficiency, knowledge of English at least at B2 level, or are native English speakers, can apply for the admission.
The admission exam consists of a theoretical report or research project (Test 1) and an interview (Test 2).

Test 1: a theoretical report/research project written in English, of 3-6 pages (1600-3000 words), on a topic related to industrial drug manufacturing or related fields. The report/project will be prepared in advance and included in the application file.
Evaluation criteria for test 1:

  1. the topic and the argumentation of its selection 20%
  2. the objectives pursued and the originality 40%
  3. the scientific accuracy and the clarity of the presentation 40%

Test 2: an interview held with the admission committee. The applicant will present the report/project enclosed in the application file and the elements that recommend him for his a professional development through this master's program
Evaluation criteria for test 2:

  1.  the originality/innovation of the report/project 25%
  2.  the candidate's motivation to follow this study program and previous connections with the pharmaceutical industry 25%
  3.  the presentation quality and the communication skills 25%
  4.  the previous studies of the candidate in the field 25%

The final admission grade of the admission exam is calculated as follows:

Final admission grade = 0.30 * Test 1 + 0.7 * Test 2

The grade for each test and the final grade is calculated with two decimals, without rounding. The minimum pass grade for each test is 5.00 and the minimum final grade for admission is 6.00. If in the last place there are several candidates with equal final grade, the classification will be made based on the grade from test 1 followed by the grade of the final bachelor's exam.
Admission of candidates is made within the available places, in the order of the final admission grade obtained at the admission exam.
For the applicants who graduated bachelor' studies in non-EU countries, the bachelor’s diploma must be recognized by the Ministry of Education and Research in Romania before the final enrolment/matriculation. The recognition procedure will be followed after admission exam, and the university will apply for bachelor’s diploma recognition at Ministry of Education and Research. This the applicants must enclosed in the application file a filled Application for the issuance of letter of acceptance to studies

9. THE APPLICATION for the ACADEMIC YEAR 2020 – 2021

PERIOD: September 24 - 29, 2020
LOCATION: online, www.umfcluj.ro
INFORMATION:    DEAN OF THE FACULTY OF PHARMACY
4 Louis Pasteur Street, 2nd floor, 400349 Cluj-Napoca,
Email: 
Tel. +40-264-406-845; +40 374 834 429

 

THE CONTENT OF THE APPLICATION FILE:

  •  Application form
  •  Bachelor studies diploma (or equivalent) *
  •  Bachelor studies transcripts form (or equivalent) *
  •  English proficiency certificate minimum B2 (or other document to prove English proficiency)
  •  Photocopy of identity card / passport
  •  Photocopy of birth certificate
  •  Photocopy of marriage certificate (if the case)
  •  Medical certificate
  •  4 passport size photographs (¾ cm)
  •  Photocopy of the payment document of the application processing fee
  •  Europass CV (in English)
  •  Statement that the candidate has not pursued a master's degree program funded from the state budget (for Romanian citizens)
  •  Theoretical report/research project (written in English) - for details, see admission procedure
  •  Personal data processing agreement
  •  Envelope file
    *If the original document is issued in other languages than Romanian, English or French, 1 authenticated copy of the original document + 1 authenticated translation in Romanian, English or French of the original document is needed;

ADMISSION EXAM:

PERIOD: September 30, 2020, 9AM.
LOCATION: online, through the Teams platform
INFORMATION:    Department of Pharmaceutical Technology and Biopharmacy, 
41 Victor Babeș Street, 40012 Cluj-Napoca.
Tel: +40-374-834-846 / +40-264-595-770

 

More information about the master's program can be found in this presentation brochure!