27th Annual EuroMeeting

Regulatory Science in relation to medicines development has been a field of growing interest for regulators and the pharmaceutical industry for a number of years. The shaping and implementation of legislation and guidelines are recognised as having a significant impact on public health as well as R&D of medicinal products. Current concepts of benefit/risk assessment, patient involvement and the regulatory pathways are being challenged and new ideas are being launched by the pharmaceutical industry, patient organisations and regulatory authorities. Universities are increasingly contributing with research projects, educational projects, and collaborations to make regulatory science a research-driven contribute to regulatory decision-making. The universities possess expertise not only within the traditional disciplines of medicines research and development but also with other disciplines such as law and pharmacoeconomics. New approaches from universities might indeed open doors for new perspectives to be explored and new partnerships to be formed. Examples are plenty such as transparency, patient involvement, definition of unmet medical needs, methodologies in clinical research, licensing and health economics. This session will show that research and educational initiatives in universities offer a plethora of opportunities for new cross-sectorial partnerships to be created – and it will headlight the important role of academia in setting the trends.