Semester I

SEMESTER I

Module 1

Duration Subjects covered Lecturer responsible
Saturday March 24, 2012
2 hours Programme assumptions
  • Training in clinical research
  • Pharmaceutical Medicine
  • Clinical research industry AD 2011
  • Programme assumptions
  • Course regulations
 Janusz Kabata, MD, PhD, MBA
3 hours The role of clinical research in drug development
  • Clinical research – definition
  • Clinical research – history
  • Terminology
  • The phases of clinical research
  • Medical product life cycle
 Janusz Kabata, MD, PhD, MBA
4 hours Statistics in clinical research
  • Introduction – planning statistical calculations in clinical research
  • Data processing in clinical research, preparing data for analysis
  • Descriptive statistics
  • Introduction to statistical inference
  • Main statistical tests with examples of application
  • Overview of advanced methods
  • The principles for planning sample size
 Sebastià Banús Gasol, MD
Sunday March 25, 2012
9 hours Bioequivalence and early phase
  • Overview
  • Biological equivalence study of generic drugs (generics) based on a comparison of pharmacokinetic parameters
  • Biological equivalence studies – alternative methods
  • Biological equivalence studies of biosimilars (biogenerics)
  • Registration of generics and biosimilars
 Teresa Brodniewicz, MSc, PhD

Module 2

Duration Subjects covered Lecturer responsible
Saturday April 21, 2012
6 hours Drug development process
  • Scientific basis for the identification of new therapeutic objectives
  • Primary research in the process of drug development
  • Genomics, proteomics, metabonomics
  • Drugs search methods
  • Potential drugs selection
  • Research based on animal models
  • Toxicological research
  • Mutagenic research
  • Preclinical trials
 Prof. Michał Markuszewski, MSc, PhD
Sunday April 22, 2012
9 hours The principles of conducting clinical research
  • Regulatory framework for clinical trials in Romania
  • Regulatory framework for clinical trials in Europe
  • FDA (US) requirements for conducting clinical trials
  • ICH Guideline for Good Clinical Practice: main  issues
  • Ethical principles for conducting clinical research described in the World Medical Association  Declaration of Helsinki
  • The role of entities involved in conducting research
  • GCP inspections in Romania
 Adina Parvu, MD

Module 3

Duration Subjects covered Lecturer responsible
Saturday May 19, 2012
9 hours Pharmacovigilance in clinical research
  • The main objectives of pharmacovigilance (PhV), concepts and legal regulations
  • Safety issues in a typical clinical test – the roles of the researcher, the monitor, the authorities and the ethical committees
  • Early risk detection in a clinical research programmes
  • Experiences from PhV history
  • Exercises
 Tomasz Dyszyński, MD
Sunday May 20, 2012
9 hours Designing clinical research
  • Design team
  • Clinical trial protocol Basic elements of a clinical trail protocol Building a clinical trail protocol
  • Basic clinical research documents Participant’s Informed Consent – elements of information for the trail participant
  • Monitoring clinical tests – objective of monitoring, types of visits, Clinical Research Form (CRF) types of data, filling and verifying data in CRF vs. source documentation, corrections Principles for keeping source documentation
 Sebastià Banús Gasol, MD

Module 4

Duration Subjects covered Lecturer responsible
Saturday June 16, 2012
9 hours Project team management part 1
  • The role of teamwork in a project
  • Elements of management through objectives
    • Principles for formulating SMART and CLEAR objectives
    • Presenting objectives and tasks as motivational tools for the team
  • Building a Team
    • The roles and tasks of a team leader
    • Stages of building a team
    • Types of behaviours within a team
    • Identifying and allocating roles to team members
    • Team decision making
 Andrzej Popadiuk, MBA
Sunday June 17, 2012
9 hours Project team management part 2
  • Team management
    • Formal and informal sources of authority
    • The concept of leadership styles
  • Conflicts in a team – structural elements
    • Management style
    • Role within the group
    • Informal leaders
    • Styles of resolving conflicts
    • Basic tools for resolving conflicts
 Andrzej Popadiuk, MBA

Module 5

Duration Subjects covered Lecturer responsible
Saturday June 30, 2012
6 hours Planning and managing a clinical trial budget
  • Types of contracts and settlement methods in clinical trials
  • Own costs and indirect costs
  • Human and material resources as the basis for budgeting projects
  • Cost estimation – top-down and algorithm-based
 Marcin Ossowski, MD, PhD
3 hours Clinical research in Romania
  • Outlays towards clinical research vs. healthcare funding in Romania
  • Clinical research vs. healthcare organization
  • The position of clinical research in the pharmacotherapeutic process
  • Public opinion polls on clinical research
  • The media’s power to influence opinions about clinical research
 Camelia Ghitan, MD, BBM
Sunday July 1, 2012
9 hours Data processing in clinical research
  • Data management
    • Designing Case Reference Forms (CRF)
    • Data Capture – methods
    • Data validation
    • Data query
    • Data coding (MedDRA, WHO-DD)
    • Presenting data and results
  • IT standards in clinical trials
  • IT systems validation
 Maciej Jakubowski, PhD