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Articolo
Inviato: 07 March 2013
Amendments to the legislative framework on pharmacovigilance have been approved. An initial set of rules were introduced in July 2012 and this second set of changes will be applicable by the end of 2013. Marketing authorisation holders are going to have to make significant changes to their pharmacovigilance systems.
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Articolo
Inviato: 07 March 2013
On 20 Dec 2012, the Patents Court of England and Wales rejected a challenge brought by Dr Reddy’s Laboratories against the paediatric extension of Pfizer’s Supplementary Protection Certificate for its existing cholesterol product atorvastatin (marketed as Lipitor.
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Articolo
Inviato: 04 March 2013
The Commission has published proposals for a revised technology transfer regime and invites comments from stakeholders.
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Articolo
Inviato: 28 February 2013
This article reviews the legal position of NICE technology appraisal guidance. It considers problems with its consistent implementation and the potential response of the pharmaceutical industry.
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Newsletter
Inviato: 22 February 2013
China issued new data protection guidelines impacting organisations without formal policies or practices for the collection, use, processing, transfer, retention and erasure of personal information.
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Video Podcast
Inviato: 21 February 2013
Gavin Lawson and Gillian Johnson talk about the issues that clients should consider following the signing of the European Unified Patent Court Agreement.
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Articolo
Inviato: 18 February 2013
The forthcoming Medical Devices Regulation is scheduled to replace the existing Medical Devices Directive and Active Implantable Medical Devices Directive by 2018. This note considers the MDR’s unique device identifier proposals, and sets out the key points for businesses preparing for UDI implementation.
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Articolo
Inviato: 15 February 2013
The Medical Devices Regulation will replace the existing Medical Devices and Active Implantable Medical Devices Directives. This note considers the MDR's proposals for medical device re processing and the re use of single use devices.
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Articolo
Inviato: 15 February 2013
May countries are introducting Unique Device Identifier systems as part of their regulation of medical devices. This note focuses on potentially business critical UDI developments in China
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Articolo
Inviato: 15 February 2013
Unique Device Identifier proposals in the new Medical Devices Regulation: implications for software developers and marketers
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