EDUCATION PROGRAM

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1 EDUCATION PROGRAM It includes 2 modules: Module of academic course (obligatory): o 112 hours for the UD of the "Fundamentals in Medical Research" o 80 hours for the CRA "Clinical Research Assistant" and CRT "Clinical Research Technician" Module consisting in a minimum of 2 weeks of professional training. This training is optional for persons working in research units. Modules in blue are specific to the UD; Modules in black are common to the UD (post-doc) and to the professional certificate of ARC and CRT (Bac +3) THE ACADEMIC COURSES MODULE 1/ 2 nd and 3 rd November 2012 Biology and New therapeutic approaches Friday 2 16h00 16h30 Introduction (Pr. Roland Asmar) 16h30 17h30 Endocrinology - Diabetes (Dr. Zelia Francis) 17h45 18h45 Urology Nephrology (Dr. Jose Khabout) 19h00-20h00 Pulmonary (Dr. Wajdy Abi Saleh) Saturday 3 9h00 10h00 10h00 11h30 11h45 12h45 13h30 16h00 16h15 17h15 Gastroenterology (Dr. Antoine Abi Rached) Hematology Immunology (Dr. Adlette Inaty) Oncology (Dr. Fadi Nasr) Genome and Therapy (Dr. Rana Bazzi) Neurology Psychiatry (Dr. Wadih Naja) 17h45 19h45 Safeguarding of persons participating in research studies, Ethics committees, Declaration of Helsinki, regulation; Responsibilities and insurance: manufacturer, investigator, hospital, patient. (Me Charles Ghafari) MODULE 2 : 13 th, 14 th, and 15 th December 2012 Thursday 13 Biology and New therapeutic approaches 16h15 17h15 Infectious diseases (Dr. Nadine Yared) 17h30 19h30 Cardiology (Pr Roland Asmar) Friday 14 : role of the CRAs and CRTs 16h - 20h Data analysis: Database constitution; Data management and analyses (Dr. Jirar Topouchian) Saturday 15 : role of the CRAs and CRTs 9h - 13h Workshop: Role of the CRAs and CRTs (Dr. Jirar Topouchian)

2 Pharmacology 14h 19h Pharmaco-vigilance: organization, methods, and imputability Role of the hospital pharmacist in clinical trials; Drug management; IVRS (central randomization) Traceability of therapeutic units (Dr. Marie -Thérèse Sawaya) Quality Friday 11 16h 20h MODULE 3 : 11 th and 12 th January 2013 Quality management in clinical research (Manual and procedures: quality assurance, quality control, audit and inspection; handling deviations and corrective actions) Standard operating procedures for a clinical trial, writing of a standard operating procedure Clinical trial conduct and data handling Saturday 12 9h 13h 14h 18h Drug development: stages, departments and careers Clinical trial: Who does what: the various professions and their obligations Trial conduct: submissions, follow-up, analysis and report. Interaction with data management, statistics, pharmacovigilance, CROs,.. Monitoring of a trial MODULE 4: 25 th and 26 th January, 2013 Friday 25: 16h - 20h -Biomedical ethics -Application of Basic medical research into Clinical medical research (Dr. Mirna Chahine) postponed until May 17 th Saturday 26 9h 13h 14h - 18h Trial essential documents: protocol, CRF, investigator brochure, informed consent Terminology and different methodologies of clinical trials Trial treatment and design: randomization, blinding, stratification Quiz Risk management: - Quality of trial s treatment: Good manufacturing practice, good distribution practice - Adverse reactions of trial s treatment: reporting, handling, coding and reconciliation MODULE 5 : 22 nd, 23 rd February 2013 Friday 22 Statistics and data analysis 16h 19h Statistical principles for clinical trials (Dr. Nadine Yared)

3 Saturday 23 Statistics and data analysis 9h- 13h Data analysis and interpretation: primary and secondary endpoints, post-hoc analysis The statistical report (Dr. Pascale Salameh) 14h 16h Data analysis and interpretation: primary and secondary endpoints, post-hoc analysis The statistical report (Dr. Pascale Salameh) MODULE 6: 8 th and 9 th March 2013 Friday 8 16h 20h Animal experimentation Studies in human, the various phases of clinical trials: preclinical phase, phase I (Dr. Raphael Laoun) Saturday 9 9h 13h Studies in human, the various phases of clinical trials: phases II, III & IV, post-marketing studies, morbi-mortality studies The major steps: duration, cost, commercialization, patents and brands (Dr. Raphael Laoun) : role of the CRAs and CRTs 14h30 16h 30 Good Manufacturing Practice & Good Distribution Practice Trial s CRF preparation MODULE 7: 22 nd and 23 rd March, 2013 Friday 22 16h -19h Saturday 23 9h30-12h00 Statistical principles for clinical trials (Dr. Nadine Yared) Applied Research in the evaluation of health care systems: evaluation of needs, selection and implementation of supply (Dr. Walid Ammar) 14h00-17h00 Oral Communication: Tools and Methods (Dr. Soulaima Chamat) MODULE 8: 5 th and 6 th April 2013 Friday 5 16h 20h Introduction to fundamental research; Organization, methods and means (Pr. Ziad Mallat) Saturday 6 : role of the CRAs and CRTs 9h 15h Contribution to the elaboration of study protocols Study implementation, pre-investigation visit Control of the quality and the reliability of the collected study data Data quality assurance: Quality control and audit; Management and follow-up of the study visits (Pr. Tabassome Simon et Pr Ziad Mallat)

4 15h30 20h Workshop: Clinical Research applied to medical devices. From development to post marketing. (Dr. Abdelnour Faraj) MODULE 9: 19 th and 20 th April, 2013 Friday 19 16h -20h Workshop: Oral Communication: Tools and Methods (Dr. Soulaima Chamat) Saturday 20 Pharmacology 9h00 12h00 14h00 18h00 Pharmacokinetics Pharmacodynamics (Pr. Atul Pathak) Toxicity Tolerability- Basic knowledge on pharmacogenetics (Pr. Atul Pathak) MODULE10: 17 th and 18 th May, 2013 Friday 17 16h - 20h -Biomedical ethics -Application of Basic medical research into Clinical medical research (Dr. Mirna Chahine) Saturday 18 9h 18h Regulatory requirements of national and international agencies and administrative commissions: FDA, EMEA, Good Clinical Practice and Good Research Practice principles, «International Conference on Harmonization» (ICH) «CoreLab». Adjucation; «Data monitoring Committee»; The organization of Research: Budget and Organization; Confidentiality (NDA) The various types of medical research: Experimental, biological and molecular research; Clinical and epidemiological research; new research prospects: industrial and non industrial (Dr. Luc Feldman et Dr. Catherine Dubanchet) MODULE 11: 7 th and 8 th June 2013 Friday 7 Introduction to bibliographic handling and to medical writing 16h 20h Tools for a better usage of PUBMED and related bibliographic research (Dr. Jean Jacques Mourad) Samedi 8 Initiation à la gestion bibliographique et à la rédaction médicale 9h 13h Tips for a good oral presentation (Dr. Jean Jacques Mourad) 14h 18h Basic principles and methods in article writing. Critique of an article (Dr Mirna Chahine)

5 THE PROFESSIONAL TRAINING A 2-week min active training session will be organized for all students having successfully achieved written tests; this training is optional for persons already working in research units. This active training phase will take place in laboratory research units, contract research organizations (CRO), academic hospital centers, or in clinical investigation centers (CIC). Training sessions will be carried out in Lebanon first, then in other countries, depending on the availability of positions and the student s grade at the final exam. A training agreement will settle and fix the training modalities and relationships between the student, the university and the laboratory where the training will take place.

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