KG Legal’s article is recommended by the main polish biotechnological media
Biotechnologia.pl, which is the main polish media in biotechnology sector, recommends KG Legal’s article on its homepage.
Klaster LifeScience’s lunch
On the 23rd February KG Legal participated in the event organised by Klaster LifeScience. The main topic of the event were new tax regulations related to B+R commercialisation. These changes are significant for inventors and companies from innovative sectors. Specialists presented new tax credit and new principles of taxation on commercialised intellectual property by a contribution in kind based on new provisions.
We publish photos from event below.
-
- Klaster LifeScience’s lunch
-
- Klaster LifeScience’s lunch
-
- Klaster LifeScience’s lunch
-
- Klaster LifeScience’s lunch
Revising the guideline on first-in-human clinical trials
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 FIH-rev@ema.europa.eu 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.
