BeNeLuxBelgiumNetherlandsLuxembourg

EMA gets more transparent with documents and conflicts of interest

18.10.2010

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest, which should make the processes in these two areas more efficient. The new rules handling potential conflicts of interests for members of EMA's scientific committees, including CHMP and COMP, are based on three pillars: robustness, efficiency and transparency. Conflicts of interests are classified into three categories - direct, indirect and no interests. In an overview of allowable interests, EMA noted that scientific committee members cannot participate in discussions, final deliberations or voting for a product if the member is or has served within the past two years as a principal investigator (PI) in a clinical trial for a related or competitor product. The policy, which was endorsed by EMA's Management Board, is expected to enter into force by the second quarter of 2011. In areas where conflicts of interests may limit the availability of experts, the Agency will look proactively for alternative experts by using its established relationships with academia and learned societies. The new policy on access to documents takes into account recommendations made by the European Ombudsman, which earlier this year criticized EMA for its transparency when the agency refused to grant public access to reports on adverse drug reactions. The new policy defines how EMA will proactively disclose such documents in the future.

BeNeLuxBelgiumNetherlandsLuxembourg

29.03.2012

Brussels – Promethera Biosciences has completed a Series B financing round, generating proceeds of €23.6m. The Belgian cell therapy company secured a capital increase of €17m from its new investors, among them the venture arms...

BeNeLuxBelgiumNetherlandsLuxembourg

19.03.2012

Leuven – Biopharmaceutical company ThromboGenics has entered into an agreement with Alcon Inc., a division of Novartis for the commercialisation of its product ocriplasmin in all markets outside the U.S. ThromboGenics said it...

BeNeLuxBelgiumNetherlandsLuxembourg

07.03.2012

Amsterdam Molecular Therapeutics has announced a financial manoeuvre aimed at getting the biotech out of a hopeless situation. The assets and – more importantly – the liabilities of the drug developer will be acquired by a newly...

BeNeLuxBelgiumNetherlandsLuxembourg

20.02.2012

Amsterdam - Amsterdam Molecular Therapeutics has announced a financial manoeuvre which is aimed to get the biotech out of a dead end. The assets and – more importantly – the liabilities of the drug developer will be acquired by...

BeNeLuxBelgiumNetherlandsLuxembourg

10.02.2012

Glasgow/Leuven - With a little help from the EU, two biotech companies are banding together to develop the first stem cell therapy against rheumatoid arthritis. UK-based Sistemic will work with TiGenix to develop the Belgian's...

BeNeLuxBelgiumNetherlandsLuxembourg

25.01.2012

Amsterdam – Two elephants in the biofuels business join forces. Dutch food and chemicals group Royal DSM and POET, LLC, a US-based ethanol producer, announced a plan to build a commercial cellulosic ethanol plant. POET–DSM...

BeNeLuxBelgiumNetherlandsLuxembourg

13.01.2012

Heerlen - Royal DSM N.V will be the industrial partner to the Panoptes consortium, which aims to develop novel drug delivery technology for the posterior eye segment. The four year project is supported by EUR4m in funding from...

BeNeLuxBelgiumNetherlandsLuxembourg

04.01.2012

Leiden - Dutch Pharming Group NV has taken a further step to secure sound financing even beyond the recent milestone payments. The drug developer announced that it has entered into a financing of approximately €8.4 million by...

BeNeLuxBelgiumNetherlandsLuxembourg

16.12.2011

Ghent – Just days after US pharmaceuticals giant Pfizer pulled out of a rheumatoid arthritis pact with Ablynx NV, the Belgian biopharmaceutical company expanded its relationship with Merck Serono. Ablynx has now entered into a...

Displaying results 1 to 10 out of 304

1-10 Next >

© 2007-2014 BIOCOM

http://www.european-biotechnology-news.com/news/messages-archive/archive-benelux/article/ema-gets-more-transparent-with-documents-and-conflicts-of-interest.html

Events

All Events

Stock list

All quotes

TOP

  • 4SC1.23 EUR0.00%
  • ACTELION108.80 CHF0.00%
  • ADDEX4.00 CHF0.00%

FLOP

  • CYTOTOOLS31.45 EUR-0.47%
  • 4SC1.23 EUR0.00%
  • ACTELION108.80 CHF0.00%

TOP

  • SANTHERA82.95 CHF20.4%
  • LONZA101.10 CHF6.1%
  • MAGFORCE6.50 EUR5.7%

FLOP

  • WILEX2.36 EUR-25.1%
  • MOLOGEN7.10 EUR-24.5%
  • VITA 343.96 EUR-18.4%

TOP

  • SANTHERA82.95 CHF3758.1%
  • CO.DON2.50 EUR228.9%
  • PAION2.48 EUR195.2%

FLOP

  • CYTOS0.26 CHF-93.6%
  • MEDIGENE4.65 EUR-68.1%
  • MERCK KGAA64.40 EUR-45.7%

No liability assumed, Date: 22.08.2014


Current issue

All issues

Product of the week

Products