FINAL_Program_CRA-_U..

Transcription

EDUCATION PROGRAM
2014 -2015
FUNDAMENTALS
IN MEDICAL RESEARCH
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 CRA and CRT (Bac +3)
THE ACADEMIC COURSES
MODULE 1/ November 7th & 8th 2014
Biology and New therapeutic approaches
Friday7
16h00- 17h00
17h00 – 18h00
18h00 –19h30
Saturday 8
8h30– 9h30
9h30 – 11h00
11h00 – 12h00
Cardiology (Pr Roland Asmar)
Neurology – Psychiatry (Dr. Wadih Naja)
Introduction (Dr Mirna Chahine)
Gastroenterology (Dr. Antoine Abi Rached)
Hematology – Immunology (Dr. Adlette Inati)
Oncology (Dr. Fadi Nasr)
MODULE 2/ November 28th & 29th 2014
Friday 28
16h00 – 17h00 Endocrinology- Diabetology (Dr Zelia Francis)
Research bases and methodology
17h00– 19h00 Safeguarding of persons participating in research studies, Ethics committees, Declaration of Helsinki,
regulation; Responsibilities and insurance: manufacturer, investigator, hospital, patient.
(Me Charles Ghafari)
Saturday 29
8h30 – 9h30
Pulmonary (Dr. Wajdy Abi Saleh)
9h30 – 12h00
Genome and Therapy (Dr. Rana Bazzi)
13h30 – 16h30 Biomedical Ethics (Dr. Mirna Chahine)
Place de Saint-Gervais 1, Boite postale 2049,
1211 Genève 1, Suisse.
Tél: +41 22 909 89 00. Fax: +41 22 909 89 39.
Foundation – Medical Research Institutes
Email: [email protected]; Web: www.f-mri.org
Achrafieh, District Hôtel Dieu 64,
Rue n°1, Olivetti Bldg, Beyrouth, Liban
Tél: +961 1 424027. Fax: +961 1 424 028
MODULE 3/ December 12th & 13th 2014
Friday 12
16h – 17h00
Infectious diseases (Dr. Nadine Yared)
17h00 – 18h00 Urology – Nephrology (Dr. Jose Khabout)
18h15 – 19h30 Application of Basic medical research into Pre-Clinical medical research (Dr. Mirna Chahine)
Saturday 13
Pharmacology
9h – 11h00
Pharmacokinetics – Pharmacodynamics (Dr Issam Kassab)
Toxicity – Tolerability- Basic knowledge on pharmacogenetics (Dr Issam Kassab)
Drug development – Preclinical and clinical development
11h15 – 13h15 Animal experimentation
Studies in human, the various phases of clinical trials: preclinical phase, phase I
(Dr Issam Kassab)
14h30 – 16h30
Animal experimentation
Studies in human, the various phases of clinical trials: preclinical phase, phase I
(Dr Issam Kassab)
16h45 – 18h45
Studies in human, the various phases of clinical trials: phases II, III & IV, post-marketing studies,
morbi-mortality studies. (OVERVIEW)
(Dr Issam Kassab)
MODULE 4/ January 9th & 10th 2015
Friday 9
Quality
17h – 20h30
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. Patrick Brunel)
Saturday 10
Clinical trial conduct and data handling
9h – 13h
Drug development: stages, departments and careers
Clinical trial: Who does what: the various professions and their obligations
(Dr. Patrick Brunel)
14h – 18h
Trial conduct: submissions, follow-up, analysis and report. Interaction with data management, statistics,
pharmacovigilance, CROs,.. Monitoring of a trial (Dr Georges Labaki)
Tél: +41 22 909 89 00. Fax: +41 22 909 89 39.
Tél: +961 1 424027. Fax: +961 1 424 028
MODULE 5/ January 29th & 30th & 31st 2015
Thursday 29
16h – 20h
Workshop 1: Clinical Research applied to medical devices. From development to post marketing.
(Dr. Abdelnour Faraj)
Friday 30
16h – 20h
Data analysis: Database constitution; Data transmission; Data management and analyses
e.CRF, e-Core Lab.
(Dr. Jirar Topouchian)
Saturday 31
9h - 13h
Manufacturing and Distribution Risk management:
-Good Manufacturing Practices & Good Distribution Practices general principles and guidelines for
medicinal products
-Our compliance to GMP and our control system as per quality standards
-Interpretation of local, EU & US GMP and GDP requirements
- Bio-equivalence studies between generic products and innovators.
(Dr. Marlene Akl & Dr Claude Khalil)
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 6/ February 20th & 21st 2015
Friday 20
Research bases and methodology :
16h –20h
Terminology and different methodologies of clinical trials
Trial treatment and design: randomization, blinding, stratification… Quiz
Trial essential documents: protocol, CRF, investigator brochure, informed consent
(Dr. Mirna Chahine)
Saturday 21
Statistics and data analysis
8h- 14h
Data analysis and interpretation: primary and secondary endpoints, post-hoc analysis …
The statistical report (Dr. Pascale Salameh)
Tél: +41 22 909 89 00. Fax: +41 22 909 89 39.
Tél: +961 1 424027. Fax: +961 1 424 028
MODULE 7/ March 27th & 28th 2015
Friday 27
16h -20h
Statistical principles for clinical trials (Dr. Nadine Yared)
Saturday 28
9h00 – 11h00
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) Dr. Luc Feldman & Dr. Catherine Dubanchet
11h00 – 13h00
« 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 & Dr. Catherine Dubanchet)
14h – 18h
Studies in human, the various phases of clinical trials: phases II, III & IV, post-marketing studies,
morbi-mortality studies.
Workshop: Conceiving a clinical development plan and phase I to III clinical protocols
The major steps: duration, cost, commercialization, patents and brands
(Dr Arnaud Lucien)
MODULE 9/ April 17th & 18th 2015
Friday 17
Introduction to bibliographic handling and to medical writing
16h00- 19h00
Elaboration of a grant proposal. Dr. Mirna Chahine
Saturday 18
9h – 13h
Workshop 2: Clinical Research applied to medical devices. From development to post marketing.
(Dr. Abdelnour Faraj)
14h30 -17h
Applied Research in the evaluation of health care systems: evaluation of needs, selection and
implementation of supply (Dr. Walid Ammar)
17h- 19h
Workshop on performing a clinical study (Dr. Roland Asmar)
MODULE 10/ May 9th, 2015
Saturday 9
9h00- 12h00
Workshop: journal club article (Dr Mirna Chahine)
13h30 – 18h30
Basic principles and methods in article writing ( Original articles, Reviews…).
Critique of an article (Dr Mirna Chahine)
Tél: +41 22 909 89 00. Fax: +41 22 909 89 39.
Tél: +961 1 424027. Fax: +961 1 424 028
MODULE 11/ 22nd & 23th May 2015
Friday 22
16h00- 19h30
Oral Communication: Tools and Methods (Dr. Soulaima Chamat)
Saturday 23
9h – 12h
Tips for a good oral presentation (Dr. Mirna Chahine)
13h30 – 17h30 Effective literature search techniques using free reliable medical Internet resources.
(Mrs Aida Farha)
MODULE 12/ 5th & 6th June 2015
Friday 5
16h -20h
Workshop: Oral Communication: Tools and Methods (Dr. Soulaima Chamat)
Saturday 6
Research bases and methodology : role of the CRAs and CRTs
9h- 13h
Contribution to the elaboration of study protocols
Study implementation, pre-investigation visit
(Dr. Tabassome Simon et Dr Ziad Mallat)
14h30– 17h
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
(Dr. Tabassome Simon et Dr Ziad Mallat)
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.
Tél: +41 22 909 89 00. Fax: +41 22 909 89 39.
Tél: +961 1 424027. Fax: +961 1 424 028

FINAL_Program_CRA-_U..

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