seminar "fundamentals in medical research" - Fondation

‫كلية العلوم الطبية‬
Faculté des Sciences Médicales
SEMINAR "FUNDAMENTALS IN MEDICAL RESEARCH"
SEMINAR 1 (24, 25, 26 March 2011)
Drug development – Preclinical and clinical development (8h)
Thursday 24 Mar
16h – 18h
The major steps: duration, cost, commercialization, patents and brands
18h30 – 20h30 Animal experimentation
Friday 25 Mar
16h – 20h30
Studies in human, the various phases of clinical trials: preclinical phase, phases II, III & IV,
post-marketing studies
(Dr. Raphael Laoun)
Research bases and methodology (8h)
Saturday 26 Mar
8h30 – 10h30
Regulatory requirements of national and international agencies and administrative
commissions: FDA, EMEA,
11h – 13h
Good Clinical Practice and Good Research Practice principles, « International Conference on
Harmonization » (ICH)
14h – 16h
« Core Lab ». Adjucation
The various types of medical research: Experimental, biological and molecular research;
Clinical and epidemiological research; new research prospects: industrial and non industrial
16h30 – 18h30 « Data monitoring Committee »
The organization of Research: Budget and Organization
Confidentiality (NDA)
(Dr. Luc Feldmann)
Fondation – Institut de Recherche Médicale
Achrafieh Quartier Hôtel-Dieu 64, Rue n°1, Immeuble Olivetti, Beyrouth, Liban.
Tel: +961 (0) 1 424 027; Fax: +961 (0) 1 42 40 28; E-mail: [email protected]; Web: www.f-mri.org
‫كلية العلوم الطبية‬
Faculté des Sciences Médicales
SEMINAR 2 (1, 2 April 2011)
Research bases and methodology
Friday 1 Apr
16h – 18h
Safeguarding of persons participating in research studies, Ethics committees, Declaration of
Helsinki, regulation (Dr. Fadi Abou Mrad)
18h30 – 19h30 Responsibilities and insurance: manufacturer, investigator, hospital, patient (Dr. Charles
Ghafari)
Data management
Saturday 2 Apr
8h30 – 18h30
The case report form, source data and the source document
Principles of the database constitution
Methods and technologies: computerization and tele-technologies
Data safety
(Dr. Franck Sévenier & Mme Isabelle Pascal)
Fondation – Institut de Recherche Médicale
Achrafieh Quartier Hôtel-Dieu 64, Rue n°1, Immeuble Olivetti, Beyrouth, Liban.
Tel: +961 (0) 1 424 027; Fax: +961 (0) 1 42 40 28; E-mail: [email protected]; Web: www.f-mri.org
‫كلية العلوم الطبية‬
Faculté des Sciences Médicales
SEMINAR 3 (26, 27, 28 May 2011)
Introduction to bibliographic handling and to medical writing
The tools of bibliographic research: index medicus, pubmed
Preparation of a reference list
Basic principles and methods in writing a research protocol
Basic principles and methods in article writing
Article review in basic research
Article review in clinical research
Thursday 26 May (17h-20h)
Saturday 28May (14h-18h30)
Organization of a clinical trial: role of the CRAs and CSTs
Friday 27 May
14h – 21h
Contribution to the elaboration of study protocols
Study implementation, pre-investigation visit
Control of the quality and the reliability of the collected study data
Saturday 28 May
8h30 – 13h
Data quality assurance: Quality control and audit; Management and follow-up of the study
visits
(Pr. Ziad Mallat & Pr. Thabassome Simon)
Inscription Fees: 200$ per person for each seminar
Information : Miss Nathalie Assemaani
Tel : +961 70 944 620 or +961 1 42 40 27
E mail : [email protected]; [email protected] .
Website: www.f-mri.org
Fondation – Institut de Recherche Médicale
Achrafieh Quartier Hôtel-Dieu 64, Rue n°1, Immeuble Olivetti, Beyrouth, Liban.
Tel: +961 (0) 1 424 027; Fax: +961 (0) 1 42 40 28; E-mail: [email protected]; Web: www.f-mri.org