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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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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: 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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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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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RAPS: Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance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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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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RAPS: New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India

2017-03-23

The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis

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