Program Overview
The Diploma in Pharmacovigilance aims to provide knowledge to postgraduate students about Pharmacovigilance (PV) and the benefits of pharmaceutical products in the labor market based on their knowledge of pharmacological background and drug toxicity. Students are also trained to suggest strategies for the best treatment results with minimal risks. Students must know the latest developments in this new science to be skilled enough to deal with the new era of drug control and ensure that students have the necessary knowledge and skills that enable them to develop professional competence in identifying various aspects of adverse drug reactions, drug safety monitoring and drug vigilance. Analyze and discuss them. The regulations and guidelines for pharmacovigilance in the European Union, the United States, and Canada will also be studied. The pharmacovigilance diploma will enable trainees to use various statistical methods in the field of statistics and analysis. The diploma will also provide postgraduate students with basic knowledge of pharmacoepidemiology, which includes multiple different study designs, and students must be provided with With all the information and skills necessary for evidence-based medicine.
Program Outline
Program Courses
PHP 791 : PHARMACOVIGILANCE-I (3+1)
This course is designed to deliver knowledge to the postgraduate students on Pharmacovigilance (PV) and risk benefit balance of marketed products based on their knowledge of the pharmacological and toxicological background of the drugs. Also, students are trained to suggest strategies for the best therapeutic outcomes with minimum risks. It will cover the following topics: PV development, basics in PV science and monitoring safety in clinical trials as well as from preclinical testing data. Phases of clinical trials will be addressed with emphasis on safety monitoring. Spontaneous reporting system will be discussed including specified system from EU, USA and Canada.
PHP 792: PHARMACOEPIDEMIOLOGY-I (2+1)
The course deals with applications and principles of pharmacoepidemiology including the international standards for the appropriate literature review, along with the advances in clinical research with the increasing use of systematic review and meta-analysis. It explores different study designs and starting from simple questionnaires and surveys up to sophisticated experimental study designs as randomized controlled clinical trials and other study designs used in the field of Pharmacoepidemiology.
PHP 793: SYSTEM-BASED ADVERSE DRUG REACTION-I (2+1)
The course aims to help students to develop appropriate knowledge and skills in drug induced disease in a system-based manner. The following topics will be addressed per each system: causative agents, epidemiology, mechanisms, clinical presentation, morbidity and mortality, and finally prevention and management. The following system ADRs will be covered:
Cardiovascular system, endocrine system, respiratory system and bone, joint and muscle ADRs.
PHP 794: MEDICAL BIOSTATISTICS (2+0)
Course starts with simple descriptive statistics through inferential one with the goal of understanding the use of statistics in signal detection and PV. Furthermore, studying biostatistics is crucial to understand clinical as well as experimental trials on drug safety and efficacy. Descriptive statistics would include data description (charts/ numeric), measures of location and spread, standard deviation and normal distribution. Proper data collection through confounding and matching and different study designs will be addresses. Inferential statistics will discuss concepts and calculation methods of probability, risk and odds. Concept of confidence interval will be discussed. Difference of two population means will be studied.
PHP 795: EVIDENCE BASED MEDICINE (2+0)
This course is intended for students to acquire and develop both the knowledge and the skills for evidence-based medicine (EBM). During this course student will use concepts obtained in previous epidemiology courses as they are applied to help solving clinical problems. Health professionals make numerous decisions when they provide care to patients. These decisions should be informed by the best evidence available from sound clinical research and patients’ values and preferences. Therefore, health professionals need to acquire knowledge and develop skills to determine the validity, the meaning and the applicability into practice of clinical research evidence findings.
PHP 797: PHARMACOEPIDEMIOLOGY-II (2+1)
The course deals with applications and principles of the observational study designs including the analytical and descriptive study methods such as: case control, cohort, longitudinal observations, cross sectional, case serious & case reports and all other study designs used in this field of pharmacoepidemiology.
PHP 798: SYSTEM-BASED ADVERSE DRUG REACTION-II (2+1)
The course aims to help students to develop appropriate knowledge and skills in drug induced disease in a system-based manner. The following topics will be addressed per each system: causative agents, epidemiology, mechanisms, clinical presentation, morbidity and mortality, and finally prevention and management. The following system ADRs will be covered: dermatological ADRs, gastrointestinal ADRs, hematological ADRs, neurological and psychiatric ADRs.
PHP 799: RESEARCH PROJECT (0+4)
Diploma trainees must conduct their research project in parallel to the theoretical part along the academic semester / year. Students will choose research topics after intensive open discussions during a symposium organized by the department in the presence of professors, and every student presents his/her idea in an interactive manner with the professors. Students will develop their projects throughout the semester under the supervision of a staff member which may contain data search, practical work or both. Students will give presentations at the end of the semester and submit a hard copy of the project which will be evaluated together with a presentation judged by an examination committee
