Press release based on European Medicines Agency (EMA) (link)
Changes are open for comments until end of February 2017
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017. Comments should be sent to FIHfirstname.lastname@example.org using the template provided.
Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on the data needed to enable their appropriate design and allow the initiation of treatment in trial participants.
On 13th May 2016 in Bonerowski Palace***** Hotel near the Main Square in Cracow took place annual General Meeting of the International Law Life Science Organisation BioLawEurope F.m.b.A. The Board of the Association entrusted polish Law Firm KG LEGAL, which has its seat in Cracow with organising this event.
On the Meeting there have been present representatives of member states’ Law Firms from jurisdiction of European Union and EFTA.
Annual Member Meeting indicated the directions of Organisation’s activity for the next year, which will be summarized in 2016 in Paris.
This year’s agenda finished with taking official “family photo” of all of the Organisation’s members made by Photography Studio, www.adamgolda.com.
On 13th May 2016 in Bonerowski ***** Palace Hotel in Cracow will take place annual General Meeting of the International Law Life Science Organisation BioLAw Europe FmbA (“BLE”). The General Meeting is the most important event considering making decisions and summarising its yearly activity. In order to emphasise the international character of this community, the General Meeting of BLE takes place every year in a different city chosen from the member states constituting the Organisation.