t involved in the production or marketing of medicines and those that are not responsible for the organization and management of research contracts, eg. universities, health care settings, patient or researchers organizations, or the investigator himself. The sponsorship aspect of non-commercial trial is defined by the Pharmaceutical Law (Article 37a): “If the owner of the...
The Regulation 536/2014 will repeal Directive 2001/20/WE and comes into application in 2019. The change of law will require adjustments in documentation evaluation timelines and all procedures connected with this process. The aim Regulations’ goal is to unify and harmonise the assessment and supervision processes for clinical trials throughout the European Union, via an EU...
We’re trying to change our lives by changing our eating style, by changing our lifestyles, going to the gym, smiling more. Does it help, all those efforts? Will it change our bodies, our genes, genomes of our children? Epigenetic All those efforts cause epigenetic changes, which means the sequence of our DNA stays the...
EMA, FDA and PMDA held a second tripartite meeting in Vienna on 26-27 April 2017. The main topic were regulatory approaches for the evaluation of antiobacterial agents and differences of data requirements. It is important to unify requirements in clinical trials industry in order to provide similar requirements for pharmaceutical companies conducting those trials...
Regulation 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). The new Regulation 2016/679 on the protection of personal data will be entered into force on 25 May...
EU have prepared new regulation which will repeal Directive 95/46/EC and will go into force in all EU member countries in May 2018. New tightened rules concerning processing of personal data and its controller should be known to all entrepreneurs and business processes should be adjusted to this regulation. Main changes Due to...
International Clinical Trials day is celebrated every year around 20th May. The first early ‘fair test’ is assumed to be the first randomized Clinical Trial conducted in May, 1747 by Edinburgh’s surgeon James Lind who wanted to treat scurvy and save lives of 12 sailors. Scurvy was thought to have killed more British sailors...
