Masterat - Industrie FARMACEUTICĂ

 

Master in Pharmaceutical Industry

 

MASTER IN PHARMACEUTICAL INDUSTRY

DIRECTOR OF STUDY PROGRAM: Prof. dr. Ioan TOMUȚĂ

DURATION: 2 years, 120 ECTS credits

STUDY PROGRAM: full-time

OBJECTIVES

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, 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 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 addressed 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.

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 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 placing on the market;

-     knowledge and understanding of technological processes of industrial manufacturing of medicines; 

-     knowledge and understanding of methods used for 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, professionals who hold a PhD degree in Pharmaceutical Sciences and work in the pharmaceutical industry, holding 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.

THE COURSE TOPICS:

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)            

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 (at choice)  

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)

 4th Semester

  1. Intellectual Property in the Pharmaceutical Field                                         
  2. Dissertation Thesis Preparation                                                                       
  3. Professional Practice                                                                         

ADDRESSABILITY:

The master's program is addressed to graduates of pharmacy, medicine (study programs with a minimum of 300 credits), biology, chemistry, physics, engineering or mathematics (who have acquired at least 240 education credits before the Bologna process or 180 education credits after the Bologna process), 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.

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.

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 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.

ADMISSION METHODOLOGY

Registrations: September 19 - 29, 2022, Faculty of Pharmacy.
Date of admission exam: September 30, 2022 starting with 9.00AM
LOCATION:    Practical work hall, Discipline of Dermatopharmacy and Cosmetology
    ground floor, street Ion Creangă, no. 12,  400010 Cluj-Napoca

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 + muster).

The selection of registered candidates for admission will be made by following an admission competition which will consist of two tests: test 1 - theoretical report or research project of 3 - 6 pages (1600-3000 words) on the theme of industrial manufacturing of drug or related fields. Theoretical report/research project will be written in English and is part of the application file; test 2 - an interview held in front of the admission committee, chaired by the master's program director.

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 with the admission committee. For admission in the academic year 2022 - 20223 the interviews within test 2 will take place on July 22, 2022, between 9.00-13.00. On 21.07.2022, all the registered applicants will receive an email with the approximate hour of the interview that will take place on July 22, 2022. Within ± 10 minutes of the scheduled time, candidates are asked to be present at the address mentioned above (Faculty of Pharmacy, Discipline of Dermatopharmacy and Cosmetology - practical works hall, street Ion Creangă, no 12) in order to hold the interview in front of the admission committee.

Within the pale of the interview, the applicant will present the report/project enclosed into the application file, and the elements that recommend him for further professional development through the master's degree in Pharmaceutical Industry study program. Evaluation criteria for test 2:

a)     the originality/innovation of the report/project, presented and argued to the admission committee                                                                                                 25%

b)     the candidate's motivation to follow this study program and previous connections with the pharmaceutical industry                                                       25%

c)      the presentation quality and the communication skills         25%

d)     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 there are several candidates with equal final grades in the last place, 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.

Topics for the entrance exam

1.  Physico-chemical principles in the formulation and manufacture of medicines

2. Implications of the characteristics of active pharmaceutical ingredients and excipients on the formulation and preparation of medicines

3. Industrial drug manufacturing technologies

Bibliography

  1. Sorin E. Leucuța. Tehnologie Farmaceutică Industrială, Editura Dacia, Cluj-Napoca, 2008.
  2. Sorin Leucuța, Marcela Achim, Ioan Tomuță, Alina Porfire, Rareș Iovanov, Sonia Iurian, Dana Hales, Lucia Tefas, Tibor Casian. Tehnologie farmaceutică industrială. Procedee de laborator, ed a IV-a, Editura Medicala Universitara „Iuliu Hatieganu”, Cluj-Napoca, 2021.
  3. Ioan Tomuță, Alina Porfire, Marcela Achim, Sonia Iurian, Dana Hales, Lucia Tefas, Tibor Casian, Rareș Iovanov. Tehnologie farmaceutică industrială. Dezvoltarea farmaceutică a medicamentelor generice, Editura Risoprint, Cluj-Napoca, 2020.
  4. Yihong Qiu, Yisheng Chen, Geoff GZ Zhang, Lirong Yu, William R Porter, editori. Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition. Elsevier Inc, 2017.
  5. M.E. Aulton. Pharmaceutics: The science of dosage form design, 2nd edition, Churchill Livingstone, Edinburgh, 2002
  6. Geoffrey D. Tovey, editor. Pharmaceutical Formulation. The Science and Technology of Dosage Forms, The Royal Society of Chemistry, London, 2018.
  7. Loyd V Allen, Howard C Ansel. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Tenth Edition, Walters Kluwer Health, Baltimore MD, 2014.

Admission Exam Guide

 

Application