E L S E V I E R Netherlands Journal of Medicine 46 (1995) 259-261

The Netherlands

JOURNAL OF MEDICINE

Announcements

Clinical Trials, Good Clinical Practice and Drug Risk Assessment Erasmus University, Rotterdam

May 8-12, 1995

A clinical trial is the basic instrument in the assessment of treatment efficiency. In the first part of the course the focus will be on methodological principles, as well as the practical conduct of therapeutic experiments and the analysis of the data. Furthermore, the objectives and historical and future perspectives of the concept of Good Clinical Practice will be discussed within the context of the recent FDA Guidelines and guidelines for drug registration in Europe. The last day of the course will be devoted to particular methodological aspects in the study of the undesirable long-term effects of drugs, as well as the principles of drug safety research and the practice of drug risk assessment.

Topics include: - principles of study design - trials with quantitative measurements - cross-over trials - case-control studies - protocol development according to Good Clin-

ical Practice - practical implications of Good Clinical Prac-

tice - registration procedures - legal aspects and the informed consent - data management and quality control - the Case Report Form - sample size calculations - survival analysis, interim analysis, meta-analy-

sis - withdrawals, dropouts, intention-to-treat - scientific and statistical reporting - monitoring, drug handling and adverse effects - systems for use in drug risk assessment.

Practical - study design - interim analysis - Case Report Form

Participants clinicians, epidemiologists and statisticians

Registration fee Dfl 1300,-

Number of participants maximum 50

Language English

Organization Erasmus University Rotterdam Dept. of Epidemiology & Biostatistics University of Amsterdam Dept. of Clinical Epidemiology and Biostatistics

Information Y.K.S. Schunselaar Office for Post Graduate Medical Education PO Box 1738 3000 DR Rotterdam tel. 010-408 7881

260 Announcements

5th Annual Erasmus Summer Programme Erasmus University, Rotterdam August 14-September 1, 1995

Modern clinical and public health practice both require a firm training in principles and methods of applied research in the health field. The Erasmus Summer Programme on quantitative medical research emphasizes an understanding of principles and methods of health research. It provides 25 introductory and advanced courses covering major aspects of research in clinical research, human genetics, health services research and epidemiology. It also features a seminar series of important current topics in medicine. Open to all health professionals, the programme emphasizes an understanding of the basics common to all applied medical research. It also provides for differentiated interests for those in clinical medicine, general practice and public health, as well as for epidemiologists and biostatisticians. In the first week the programme comprises introductory courses in clinical research and clinical epidemiology, in public health research and in biostatistics. The second week emphasizes study design in medical research, with different modules for those in clinical medicine and in public health. In the third week specific important issues in medical research are addressed, including for example courses in advanced statistics, clinical trials, drug risk assessment and medical technology assessment.

Registration fees it is possible to attend one, two or three weeks. one week Dfl 2000,- two weeks Dfl 2500,- three weeks Dfl 3000,-

Language English

Programme committee Albert Hofman Diederick E. Grobbee Dick Lindhout Johan P. Mackenbach Olli S. Miettinen Cuno S.P.M. Uiterwaal

Information Y.K.S. Schunselaar Office for Post Graduate Medical Education PO Box 1738 3000 DR Rotterdam tel. 010 - 408 7882

Announcements 261

20th International Symposium on Blood Transfusion: Trigger Factors in Transfusion Medicine

Martinihal, Groningen October 4 -6 , 1995

Chairman: Dr. E.L. Snyder, New Haven, CT, USA Opening address: Prof.Dr. E. Borst-Eilers

Session I. Demand and supply Moderators: P.C. Das and L.T. Goodnough a. Custom-oriented quality systems in transfusion medicine b. Communication mechanisms between the bedside and the blood bank c. Informing the transfusion recipient: how much is enough? d. Factors affecting the clinical transfusion demands e. Developments in transfusion medicine: what triggers the initiative?

Session II. Product qualities and characteristics Moderators: H.J.C. de Wit and D.B.L. McClelland a. Factors defining the clinical needs for supportive haemotherapy b. Factors effecting the clinical efficacy of blood transfusion c. The clinical relevance of biological functions of white cells d. Platelets: what qualities and characteristics justify the need for transfusion? e. The clinical relevance of clotting factor characteristics

Session III. Transfusion policies and clinical practice Moderators: J.Th.M. de Wolf and W. Murphy a. Perception and analysis of risks b. The process of clinical indication setting and decision-taking in blood transfusion c. Surgical criteria for blood transfusion: how far should we go? d. Transfusion policies, good clinical practice and the need for protocols and documentation e. Ethical aspects of the transfusion of blood: restrictive or justifying?

Session IV. Evaluation and feed-back of transfusion policies Moderators: C.Th. Smit Sibinga and E.L. Snyder a. Evaluation of bedside transfusion practice: benefits vs. risks b. The clinical consultative role of the blood bank in clinical transfusion c. Audits in transfusion medicine: a trigger mechanism to optimise clinical practice d. The impact of legislation and regulations on the clinical practice in transfusion medicine: regulating

triggers in transfusion medicine

Information and Registration: Symposium Secretariat Red Cross Blood Bank Grongingen-Drenthe P.O. Box 1191 9701 BD Groningen The Netherlands

Tel. + 31-(0)50-137777 Fax + 31-(0)50-137777 (office hours)