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Master of Science in

Virtual Pharmaceutical Regulatory Affairs

 

Ever-changing laws and regulations are driving demand for regulatory affairs professionals who can help companies effectively bring medical products to market. To prepare you to effectively manage pharmaceutical regulatory activities, to familiarize with drug laws and regulations considering every step of production, control, distribution and registration, to gain the essential knowledge and skills required to help companies navigate an increasingly complex regulatory environment, to acquire the foundation necessary to observe a variety of fields, including medical product development, pharmaceutical sales, cosmetics product development, to examine every step of the drug development and regulation process, to sharpen the understanding of the laws that govern the development, manufacturing, and commercial distribution of drugs, to analyze how researches in this domain can be effective in pharmaceutical production, TUMS Virtual School offers the Master of Science in Pharmaceutical Regulatory Affairs.

In this context, School of Pharmacy of Tehran University of Medical Sciences (TUMS), as the most reputable School of Pharmacy in the country, in cooperation with TUMS Virtual School offers Master of Science in Pharmaceutical Regulatory Affairs. The objectives focused on defining and designing regulatory requirements for pharmaceuticals, medical products and diagnostic systems, preparing specialist, completing approval procedures, compiling approval documentation, constructing and implementing vigilance and monitoring systems, drawing up and assessing approval strategies.

This unique graduate degree is designed to deepen your understanding of current regulations and your practical application in the development and commercialization of drugs and medical device products. Master of Sciences in Pharmaceutical Regulatory Affairs courses within this program will provide you with the integrated knowledge and broad perspectives you need to effectively manage the regulatory process. From discovery to commercialization, this Pharmaceutical Regulatory Affairs master’s degree will cover the steps that are required to bring a medical product to market, both in Iran and around the globe.

Course Structure

Utilizing many different methods of teaching based on students' class participation, the program actualized as a partial attending course. The face-to-face classes in each semester will be offered in the first and last part of the semester, maximum 4 days for each course, according to the course structure determined in the Department. It should be noted that all exams will be paper-based.

Generally speaking, each department will offer 12 to 14 units in each semester and the students of Virtual School should take a minimum of  6  units  per term.( The Department’s confirm is needed.)

Please be considered that the maximum years of study authorized by the School will be 6.

Before enrolling in the course, you are advised to read “ the Master of Virtual Pharmaceutical Regulatory Affairs handbook ” entry for information on course overview, objectives, structure, major and minors, subject options and entry requirements.

Admission Requirements

I.               General Requirements

The applicants can take part in the exam under the following conditions:

·       Having physical and mental health

·       Being eligible according to I.R.I regulations

·       Possessing educational and disciplinary measures and regulations of the School.

Note 1: Handicapped can’t work with computer are not allowed to take the exam.

 

II.           Special Requirements

1.   Educational Status

1.1.        In order to be admitted to the program you must have a relevant degree: MD, MD in Dentistry, MD in Pharmacy, professional doctorate in Veterinary, M.Sc. / B.Sc. in Pharmacy, Analytical Chemistry, Applied Chemistry, Pure Chemistry, Alimentary Sciences Technology, Cell & Molecular Biology (Microbiology).  

Note 1: The applicants with equivalent degrees or course certificate are not allowed to take the exam.

Note 2: Applicants who do not possess the level of qualifications outlined above such as invalided documents, the process of their admission will be failed.

1.2.        The seniors are allowed to take the exam only when they terminated their studies in October 2013.

 

2.   Commitments

The admitted applicants have no duty service commitment to Tehran University of Medical Sciences.

 

3.   Admission

 

3.1.        The entrance exam will be paper-based, decentralized and it will be taken under the supervision of Vice-Chancellor for Education of Tehran University of Medical Sciences.

3.2.        The exam is conducted in two phases:

Stage I: The preliminary paper-based examination consists of tests. It should be noted that in the preliminary examination, the number of candidates selected for the interview is twice the number of vacancies.

StageII: Officially called the "Interview", the object of the interview is to assess the personal suitability of the candidate for a career in Virtual School by a board of competent and unbiased observers. The test is intended to evaluate the personality of a candidate. In broad terms, this is really an assessment of not only a candidate's intellectual qualities, but also social traits and interest in current affairs.

 Some of the qualities to be judged are critical powers of assimilation, clear and logical exposition, balance of judgment, variety and depth of interest, ability for social cohesion and leadership, and intellectual and moral integrity.

The interview is not intended to be a test either of the specialized or general knowledge of the candidate, which has been already tested through written papers. Candidates are expected to have taken an intelligent interest not only in their special subjects of academic study, but also in the events which are happening around them both within and outside their own state or country as well as in modern currents of thought and in new discoveries which should rouse the curiosity of all well-educated youth.

The candidates are requested to bear in mind:

·       The minimum marks of 55% in preliminary exam and 45% in interview are necessary for each applicant.

·       Candidate just applied but not appeared at the exam is not an attempt.

·       If you don’t attend the secondary exam, interview, it is expected to record a grade of ‘X’ which means Absent Fail, and in this case the interview will not be repeated.

·       In case of disqualification or cancellation of candidature, the fact of appearance of the candidate at the examination is not an attempt.

·       The entire process from the notification of the Preliminary examination to declaration of the final results takes roughly 4 months.

3.3.        Applicants’ abilities in computer skills (IT basic conceptions, ICDL, and basic communication skills) are counted for those who have passed preliminary exam.

Note1: Applicants who have passed the preliminary written test, should take both interview and computer skills exam.

Note2: The result of Computer Skill exam is not taken into account, hence; the minimum mark is necessary to participate in the course. 

 

3.4.        Exam Resources

Reference

Course

v "Basic & Clinical Pharmacology", Catzong

The following chapters:

ü Basic principles – the recipient of medicines and pharmacodynamics

ü Pharmacokinetic and pharmacodynamics-  basic and clinical evaluation of  new medicines

ü Immune-pharmacology- introduction to Toxicology – certain aspects of Pharmacology in Pregnancy & children

ü  Herbal Remedies and Food Supplements Medicine no need to Prescription – Vaccines – immune-globin and other products

 

 

 

 

Pharmacology

v " Drug Quality Control", Gholam Ali Kazemi Fard, Chapters 1 to 4

Drug Physicochemical  Control

v " Quality Control against Germs, Cosmetics Products and non-sterile drugs" , transleated by Dr. Fazli Bazzaz, chapters 1 to 4 & 11 to 15 

Drug Microbial Control

v "Pharmaceutics: the knowledge of designing drug forms", Michel Olton, Mashhad University of Medical Sciences

ü An Introduction to Bio-pharmacy- chapter 15

ü Bioavailability- Physicochemical Factors- chapter 17

ü Evaluation on Pharmaceutics Characteristics-chapter 18

 

Pharmaceutics

 

 

 

 

 

 

 

 

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