DEPARTMENT OF PHARMACEUTICAL SURVEILLANCE AND ECONOMICS

At the Department students are learning the business and management side of health care and pharmaceutical industry. It provides strong focus on the basic s

ciences, combining biological and pharmaceutical science coursework with marketing and general management studies. The program prepares students for a variety of careers, including pharmaceutical sales; health care and health information management; food, drug and medical device industry regulatory oversight; and pharmacy distribution system development and implementation. Graduates are also prepared to continue their education in post-graduate programs that could include business, science, or regulatory affairs masters degrees.

 

Classes taught:

·         Pharmacovigilance

·         Pharmaceutical Management and Organization

·         Pharmaceutical Product Registration 

 

Classes taught:

1. Pharmacovigilance

Overview:

Introduction of basic definitions and the key concepts of Pharmacovigilance.

Specific aims:

To provide a specific knowledge on the system requirements and the steps of effective pharmacovigilance for pharmacists, and discussing the scientific and legal aspects and organization

Specific Topics:

1.      Key Elements and Activities of the PhV

2.      Concept of reporting, coding, signal detection

3.      Risk management approach: RMP, risk minimization

4.      Continuous pharmacovigilance, PASS, PAES;  DSUR/PSUR

5.      GVP Modules and  public health

6.      Pharmacovigilance during drug development process.

7.      Documentation of clinical trial, reference safety information

8.      Basics of the scientific and statistical approaches

 

2. Pharmaceutical Management and Organization 

Overview:

The purpose of the subject is to provide a scope of the regulatory, legal, and  macro economical, aspects of pharmaceutical drug development, marketing and retail. Highlights are given to the key scientific trends, organizational and financial elements of national and international guidelines.

Specific Topics:

  1. The key aspects and trends of the global market of medicinal products.
  2. Statistical and scientific approaches evaluating the health parameters
  3. Funds of the health care systems and implications in macroeconomy
  4. Characteristics, cost and timeline implications of drug development
  5. Overview of drug distribution process: manufacturers, marketing authorization holder, wholesalers, pharmacy retail and customers.
  6. Marketing and pharmaceutical communications of products
  7. Operation, management, financial basis of a retail pharmacy.
  8. Quality definitions
  9. Drug Information: Safety, marketing and communications on drugs.

 

3. Pharmaceutical Product Registration 

 

Overview:

The subject introduce the major steps and the concepts of product registration in Hungary / and overview with the EU centralized and MRP processes.

Specific aim:

To provide a knowledge on the  requirements and the steps of pharmaceutical registration for MAH purpose and discuss the scientific and legal needs and organizational approach

 

Scientific Profile and Student Research Fellow Options

The faculty members of the Department are in collaboration with prominent KOL in the area  continuously acquire, internalize and discuss new concepts and knowledge, especially concerning the approach of PhV and Pharmaceutical organization in order to improve drug safety, the aspects of prevention. Attention is given to facilitate and support the level of co-operation of researchers representing basic science and clinical research, and/or interdisciplinary studies, aimed at improving, preserving and restoring the health of the society.

 

Special attention is given to support the students during their studies, in order to acquire real-life knowledge on the subjects, and utilize the scientific thinking in their daily work. Additional to those the facilitation and the participation in accredited or postgradual programs are set as priorities