seminar "fundamentals in medical research" - Fondation
Transcription
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