MODULE 10 Clinical trials reporting and auditing February 2017

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1 MODULE 10 Clinical trials reporting and auditing February 2017 POST-GRADUATE PROGRAMME IN PHARMACEUTICAL MEDICINE & MEDICINES DEVELOPMENT SCIENCES

2 CLINICAL RESEARCH AND THE ART OF SCIENTIFIC WRITING Phillip S. LEVENTHAL Phillip S. LEVENTHAL Ph.D., Scientific Writer, 4Clinics Belgium AUDITS OF CLINICAL TRIALS Karin REYGAERT Setting up a sound clinical quality system to conduct clinical trials is not only crucial but a regulatory requirement for the sponsor and the investigator site. A review of the systems used in clinical trials and the common audit findings will be presented. Publication of experimental results is one of the most important (and one of the most often neglected) aspects of clinical research. Putting data and conclusions logically onto paper is a difficult task for many researchers. This course will give advice on : pre-writing preparation how/where to start when writing a manuscript for publication presentation of data/text submission to a «peer-review» journal dealing with the reviewer's comments. Preparation of review documents for regulatory submissions will also be discussed. Karin REYGAERT Pharmacist, Associate Director GQRC CT&C, Bristol-Myers Squibb RE Dipak KALRA President of the EuroRec Institute, President of i ~HD, Professor of Health informatics, UCL, Visiting Professor, University of Gent REUSING HEALTH DATA FOR CLINICAL RESEARCH Dipak KALRA Data from electronic health records can be used to determine the recruitment potential of various hospitals and to simulate the impact of changes in the protocol on this potential. However several challenges need to be addressed, in particular privacy protection and semantic interoperability. The lessons learned from the EHR4CR IMI project will be presented.

3 Denis LACOMBE M.D., M.Sc., European Organisation for Research and Treatment of Cancer (EORTC), Brussels AN INVESTIGATORS NETWORK : THE EORTC Denis LACOMBE This course will present the specific aspects of investigator-initiated clinical trials CLINICAL TRIALS IN DEVELOPING COUNTRIES-CHALLENGES AND OPPORTUNITIES Eckart W. SCHWARZ Traditionally, the majority of clinical development activities sponsored by multinational pharmaceutical companies have been carried out within the context of developed countries. This situation appears to be progressively changing, with more and more clinical trials being conducted in developing countries. Conduct of clinical trials in developing countries must not only follow the same stringent ethical and procedural standards as countries in the developed world, but also, and equally importantly so, there must be a fair benefit to study subjects and communities involved. Informed Consent procedure must be followed. Post trial access to study drug has been a controversial topic. Many angles need to be considered, for instance, to whom should this be extended (trial subjects or entire population), and for how long (until launch or life-long)? Eckart W.SCHWARZ M.B., Ch.B., University of Bristol, Vice President & Global head of Worldwide Regulatory Compliance, GSK, Philadelphia, USA Isabelle CAMPINE MD, Director Regulatory Affairs, UCB Pharma, Brussels DATA INTERPRETATION AND WRITING THE FINAL STUDY REPORT Marc de LONGUEVILLE & Isabelle CAMPINE This course describes the various activities that take place after the end of the clinical part of a trial. Marc de LONGUEVILLE MD, PhD, FFPM, MBPCM, Sr Medical Director Immunology Safety and registries, UCB BioPharma SPRL

4 Wednesday 22 February 2017 Thursday 23 February Welcoming participants Marc de LONGUEVILLE, Isabelle CAMPINE Data interpretation and writing the final study report Marc de LONGUEVILLE, Isabelle CAMPINE Data interpretation and writing the final study report Phillip LEVENTHAL Clinical research and the art of scientific writing Coffee break Phillip LEVENTHAL Clinical research and the art of scientific writing Denis LACOMBE Specificities of investigator-initiated trials : the EORTC example Karin REYGAERT Audits of clinical trials Coffee break Karin REYGAERT Audits of clinical trials Lunch Eckart SCHWARZ Quality compliance and risk management in clinical research Eckart SCHWARZ Clinical trials in developing countries Dipak KALRA Reusing health data for clinical research

5 REGISTRATION FEES FOR THE COURSE AND EXAMINATION Attendance to the 16 modules, access to all course notes on the private domain of our web site and examination: Attendance to 4 selected modules, access to all courses notes on the private domain of our web site and examination : Attendance to one individual module, with a copy of the course notes : 600 Examination only, with access to all course notes on the private domain of our web site : Second or third attempt at the examination : 200 Registration can be done at any time during the year. Registration to a module includes two lunches and beverage breaks. A discount can be offered to candidates who are neither employed nor sponsored by a biopharmaceutical company. Register by , by sending the completed registration form to pharmed@ulb.ac.be. Download the registration form on our web site Payment should be made upon receipt of our invoice. The courses take place in Brussels, at HOTEL ERASME : Route de Lennik Brussels (Phone : 32-02/ ) For more information please contact : REGISTRATION AND INFORMATION Mrs Bahija JELLOULI PHARMED ULB CP611 Route de Lennik, 808 B 1070 Bruxelles BELGIUM pharmed@ulb.ac.be - Phone :