EDUCATION PROGRAM

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يبطلا مولعلا ةيلك

ة

Faculté des Sciences Médicales 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 Gastroenterology (Dr. Antoine Abi Rached)

10h00 – 11h30 Hematology – Immunology (Dr. Adlette Inaty) 11h45 – 12h45 Oncology (Dr. Fadi Nasr)

13h30 – 16h00 Genome and Therapy (Dr. Rana Bazzi) 16h15 – 17h15 Neurology – Psychiatry (Dr. Wadih Naja) Research bases and methodology

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

Research bases and methodology : role of the CRAs and CRTs

16h - 20h Data analysis: Database constitution; Data management and analyses (Dr. Jirar Topouchian)

Saturday 15

9h - 13h Workshop: Role of the CRAs and CRTs (Dr. Jirar Topouchian)

EDUCATION PROGRAM

2012 -2013

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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)

MODULE 3 : 11

th

and 12

th

January 2013

Quality

Friday 11

16h – 20h 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 (Dr. Lena Massad)

Clinical trial conduct and data handling

Saturday 12

9h – 13h Drug development: stages, departments and careers

Clinical trial: Who does what: the various professions and their obligations (Dr. Lena Massad)

14h – 18h Trial conduct: submissions, follow-up, analysis and report. Interaction with data management, statistics,

pharmacovigilance, CROs,.. Monitoring of a trial (Dr. Lena Massad)

MODULE 4: 25

th

and 26

th

January, 2013

Friday 25:

Research bases and methodology

16h - 20h -Biomedical ethics

-Application of Basic medical research into Clinical medical research

(Dr. Mirna Chahine) postponed until May 17th

Saturday 26

9h – 13h Trial essential documents: protocol, CRF, investigator brochure, informed consent

Terminology and different methodologies of clinical trials

Trial treatment and design: randomization, blinding, stratification… Quiz (Dr. Lena Massad)

14h - 18h Risk management:

- Quality of trial’s treatment: Good manufacturing practice, good distribution practice

- Adverse reactions of trial’s treatment: reporting, handling, coding and reconciliation

(Dr. Lena Massad)

MODULE 5 : 22

nd

, 23

rd

February 2013

Friday 22

Statistics and data analysis

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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

Drug development – Preclinical and clinical development

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) Research bases and methodology : role of the CRAs and CRTs

14h30 – 16h 30 Good Manufacturing Practice & Good Distribution Practice Trial’s CRF preparation

(Dr. Lena Massad)

MODULE 7: 22

nd

and 23

rd

March, 2013

Friday 22

16h -19h Statistical principles for clinical trials (Dr. Nadine Yared)

Saturday 23

9h30 -12h00 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

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)

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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 Pharmacokinetics – Pharmacodynamics (Pr. Atul Pathak)

14h00 – 18h00 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)

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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.