Institute of Clinical Research Training and Diploma in the Middle East
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Dear Candidates Signën Clinical Discoveries limited the MENA region representative for the ICR would like to invite you to attend the Second course managed by The Institute of Clinical Research in Middle East region for clinical research and Diploma Exam. By attending this course you can get benefit from the following:
• The Institute of Clinical Research (ICR) is the oldest and largest not-for-profit organization formed originally in 1978, and is the professional body for clinical research personnel. • With the significant achievement of gaining Institute status, a number of developments have been made and more recently the membership levels were restructured. The movement between levels will depend on academic achievement, experience in clinical research and demonstration of continued professional development. One way to facilitate movement between the affiliate and registered member (RICR) categories is the ICR Registered Membership Examination (ICRExam). • For more details please visit www.icr-global.org
• An alternative route into Registered Membership (RICR). • A route for those wishing to demonstrate their knowledge of clinical research. • A method of formal assessment that can be used as a follow up to a learning program. • The content of the ICR Exam was designed to test the candidate’s broad overview of the essential aspects of clinical research not just guidelines and regulations. It will also test the candidate’s ability to apply that knowledge. The ICR Exam was prepared by a group of individuals from blue chip pharmaceutical companies, Clinical Research Organizations, study sites, data management/statistical and device companies.
• Guidelines and Regulations: • ICH GCP • EU Directive 2001/20/EC • Awareness of ISO 14155 for medical device trials • EU Directive 2005/28/E • Basic process for achieving marketing approval / regulatory affairs •Design and Analysis of Clinical Trials: • Phases of clinical trials • Basics of clinical trial design – randomization, blinding, types of design • Basic statistical aspects of clinical trials •Process of Conducting A Clinical Trial: • Drug development • The process of ethical approval • Pre study organization • Protocol design • CRF design • Informed consent • Ethics approval • Monitoring and Source Data Verification • Safety reporting and adverse events • Essential documentation • Audit and inspections.
Membership Grades In ICR For more details http://www.icr-global.org/membership/
• Instructor: • Sue Fitzpatrick • Biography • Sue Fitzpatrick gained a degree in Pharmacology and joined the Pharmaceutical Industry in 1980. She has been responsible for the management and audit of CRAs and clinical trials in a wide range of therapeutic areas. Sue was elected to the executive board of The Institute of Clinical Research in 1991 and is an honorary Fellow of The Institute. As Education Manager she is responsible for the provision of postgraduate courses in collaboration with Cranfield University, Manchester University and is an honorary lecturer at Liverpool John Moore’s University. • Sue was a member of The Pharmaceutical Industry National Training Organisation and was instrumental in developing the first set of occupational standards for CRAs. • She continued her work on occupational standards with SEMTA the sector skill council for Science, Engineering and Manufacturing Technologies and the Institutes own professional standards. She continues her work on enhancing standards and is an assessor for the Science Council. • She was a member of the GCP committee of the Faculty of Pharmaceutical Medicine and helped develop a certification examination for Physicians and other research personnel. She has devised various world wide examinations for the Institute. • She has authored many articles and books on clinical research and career development topics.
No need to travel to UK to have the course, now the professional certification is at your hands with affordable fees of 2660 USD. The course fee includes expert tuition, comprehensive course notes, and lunch and refreshments. (travel and accommodation if any is not included). - Don't come alone, Special Discounts for groups (Min 10 persons). - Flexible installments system is available with special discount for early payment. - Corporate rates are available upon negotiation. Course will be on: 2-7 Oct. 2010 in Cairo, Egypt, limited number available reserve your place early. Now You Can Register Online HERE For registration and more information please contact: Signën Clinical Discoveries Ltd, UK 348 Salma Centre Madinah Road, PO Box 55981 Jeddah 21544 Saudi Arabia T/F +966 2 6504518 +966 590570012 +966 565538130 Egypt: 0020113449964 |
