Drugs between Research and Regulations

Chronic Concern on Chronic Toxicity Studies.- Chronic toxicity tests, current problems and possible solutions.- What can be gained from a retrospective analysis of chronic toxicity studies?.- The role of carcinogenicity studies in risk assessment.- Alternatives to chronic toxicity studies.- Clinical Trials and Medical Practice.- What good are clinical trials?.- Clinical guidelines - a help or a hindrance?.- Clinical trials in the natural environment.- Clinical trials and the general practitioner.- Clinical trials and chronic diseases.- Alternatives to clinical trials in post-marketing research on drug effects.- The Future of Long-Term Intervention and Prevention Studies.- The future of long-term intervention and prevention studies - methodological aspects.- Lessons for the future from long-term studies with beta blockers and hypolipidaemic agents.- Rauwolfia derivatives and breast cancer: how do we know when we have the answers?.- The organisation of long-term intervention and prevention studies.- New Biostatical Concepts for Clinical Trials.- The explanatory and pragmatic approaches in clinical trials.- Alternatives to classical randomized trials.- Data quality assurance with particular regard to protocol violations.- Clinical Trials in Children.- The need of clinical drug trials in children.- Ethical restrictions in clinical trials in children.- European Drug Registration.- The role of the EEC in the harmonisation of drug registration.- Clinical trials - European recommendations.- Special Lecture.- The Pharmaceutical Industry - research and responsibility.