European Centre for Clinical Research Training, Investigators/site personnel, Clinical Operations/GCP, Pharmacovigilance, Clinical Supply Management, Data Management/Statistics, Clinical QA, Medical Training, Medical Devices, Regulatory Affairs, European, Center, clinical, Research, Training, GCP, Course, Brussels, Belgium, EUCTD in Belgium with participation of the Belgian CA Laboratory Testing in Clinical Research, The ECG in Clinical Research, Clinical Project Management, Medical Devices in Clinical Research, Clinical Research Training: Junior CRAs, Course Description, This is an introductory 2-day course, specifically designed for persons entering the area of clinical research and who have zero to 12 months experience as a Clinical Research Associate (CRA).The course focuses on the different phases of drug research, the life cycle of a clinical trial, ICH/GCP and the role of a CRA. In addition to the theory, interactive workshops with sample protocols and case report forms (CRFs) will introduce the participants to the fascinating world of clinical research. Course Objective, To provide the basics of the role of clinical research in drug development, To provide the basic elements of clinical trial methodology, To detail the principles of Good Clinical Practice (GCP), To familiarize the participants with expected job tasks, European Clinical Trials Directive: Understanding the Directive & Implementing Guidelines, Course Description, Do we all know the directive and guidance documents well enough to implement them in our day to day work? In this 1-day programme the contents of the Directive as well as the implementing guidance documents will be interactively presented. A state-of-the-art update on implementation in the European Member States will be provided. Course Objective, Detailed review of the Directive and guidance documents, Discussion on how to be compliant with the directive, Workshop on how to reach successful implementation, Investigators site personnel, Clinical Operations GCP, Pharmacovigilance, Clinical Supply Management, Data Management/Statistics, Clinical QA, Medical Training, Medical Devices, Regulatory Affairs, Haematology, Clinical chemistry, course, Leopold II Laan 281, Junior CRA, Advanced CRA, Investigators, People Management, Clinical Project Management, Medical Devices in Clinical Research, Clinical Study Coordinators, Understanding the EU CTD & Implementing guidelines, EU CTD: Implementation in Belgium, Statistics in Clinical Research, How to read a Medical Journal Article, Time Management, The ECG in Clinical Research, Laboratory Testing in Clinical Research, Training Vouchers/Opleidingscheques, course schedule, Junior CRAs, Clinical Research Training for Advanced CRAs, Clinical Research Training for Clinical Study Coordinators, European Clinical Trials Directives, Understanding the Directives and Implementing Guidelines, European Clinical Trials Directives: Implementation in Belgium, With coorporation of the Belgian Competent Authority, Statistics in Clinical Research, Basic Principles and Pitfalls of Statistical Analysis, Laboratory Testing in Clinical Research, Clinical Development of Vaccines, Medical Devices in Clinical Research, People Management Skills, Tailored courses, Introduction to GCP Auditing in Clinical Research, contact us, Benedikt Van Nieuwenhove, Nira B. Garty, Francisco J.J. Harrison, Peter Burggraeve, Hugo Van den Bergh, Marleen verbeeck, Stephen Bentley, Dr. Barbara Schnurr, Introduction to ICH-GCP, Medical Writing, Clinical Research Training for Study Coordinators, Pediatric Clinical trials, Introduction to ICH-GCP, Clinical Project Management Training, Understanding the EU Clinical Trials Directives & Guidelines

European Centre for Clinical Research Training, Investigators/site personnel, Clinical Operations/GCP, Pharmacovigilance, Clinical Supply Management, Data Management/Statistics, Clinical QA, Medical Training, Medical Devices, Regulatory Affairs, European, Center, clinical, Research, Training, GCP, Course, Brussels, Belgium,

EUCTD in Belgium with participation of the Belgian CA Laboratory Testing in Clinical Research The ECG in Clinical Research Clinical Project Management Medical Devices in Clinical Research

Clinical Research Training: Junior CRAs Course Description This is an introductory 2-day course, specifically designed for persons entering the area of clinical research and who have zero to 12 months experience as a Clinical Research Associate (CRA).The course focuses on the different phases of drug research, the life cycle of a clinical trial, ICH/GCP and the role of a CRA. In addition to the theory, interactive workshops with sample protocols and case report forms (CRFs) will introduce the participants to the fascinating world of clinical research. Course Objective To provide the basics of the role of clinical research in drug development To provide the basic elements of clinical trial methodology To detail the principles of Good Clinical Practice (GCP) To familiarize the participants with expected job tasks

European Clinical Trials Directive: Understanding the Directive & Implementing Guidelines Course Description Do we all know the directive and guidance documents well enough to implement them in our day to day work? In this 1-day programme the contents of the Directive as well as the implementing guidance documents will be interactively presented. A state-of-the-art update on implementation in the European Member States will be provided. Course Objective Detailed review of the Directive and guidance documents Discussion on how to be compliant with the directive Workshop on how to reach successful implementation

Benedikt Van Nieuwenhove has a Ph.D. in Pharmaceutical Sciences and has been working for Harrison Clinical Research since 1997. Starting his career as a CRA, he now manages the Benelux operation within the Harrison Clinical Research Group. His valuable experience in each step of the clinical research process, within a CRO, together with his previous training at the University of Ghent serve as the sound platform for the current training courses. Nira B. Garty is a Ph.D. in Biochemistry from the Weizmann Institute for Research in Israel and has extensive scientific background. She has worked in the field of clinical research both in a start-up pharmaceutical company and as a vice-president for clinical research in a CRO before joining Harrison Clinical Research as the Managing Director of the office in Israel. She has lectured in two extensive courses for management of clinical trials in extra curricular university studies. She lectures on GCP issues to investigators and hospital staff locally and in internationally.

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