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GMP: GCP: EMA Draft Guideline relating to the Trial Master File

2017-05-11

In April 2017 the European Medicines Agency (EMA) has released a draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content,

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RAPS: FDA Offers its Views on Medical Device Trials

2017-05-11

Officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) took to the New England Journal of Medicine on Thursday to explain the wide

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RAPS: Biosimilars in the EU: New IMS Report Shows Savings Through Competition

2017-05-11

A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.The

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RAPS: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017)

2017-05-11

EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials.
The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials.

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GMP: Packaging: Pharmeuropa Draft Chapters regarding PVC

2017-05-11

A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of

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EMA: New guide on biosimilar medicines for healthcare professionals

2017-05-11
The European Medicines Agency (EMA) and the European Commission
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RAPS: UK on Brexit Implications: ‘Significant Benefits’ to Remain Part of EMA

2017-03-23

The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in

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MHRA: MHRA's Interpretation of Cross Contamination & PDEs

2017-03-23

The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept can be

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RAPS: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance

2017-03-23

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft

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