The European Medicines Agency has adopted a policy of proactive publication of reports from clinical trials. The rule of transparency of clinical results is to be implemented starting 1 January 2015, and the first publications should coincide with entry into force of the EU’s new Clinical Trials Regulation, scheduled for 28 May 2016. What will the new rules mean in practice?
The EU’s proposed General Data Protection Regulation has raised issues about the impact that new privacy protections may have on how clinical trials are conducted and information about patients is used for research purposes. Sylwia Paszek of Wardyński & Partners discussed concerns about the draft regulation in an interview by Simon Fuller.
An interview with Katarzyna Wójcicka, chair of the Expert Council of the Polish Council for Supplements and Nutritional Foods (KRSiO), and Joanna Krakowiak, chair of the Ethics Committee of KRSiO and legal adviser in the Life Science and Regulatory Practice of Wardyński & Partners.
A dispute over the documentation to the medicine Esbriet shows how much controversy is stirred up by the disclosure of registration documents for medicines to third parties. How to balance the interests of innovative pharmaceutical companies, manufacturers of cheaper generics, and doctors who seek full knowledge of the safety and efficacy of the drugs they prescribe?
The dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector.
The Polish parliament is currently discussing draft amendments to the Law on Food Safety and Nutrition which aims to eliminate unhealthy food from school shops and to prohibit all forms of promotion of unhealthy foods within educational institutions.