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23 October 2014

 
22 October 2014

A top World Health Organization official has disputed reports that an Ebola vaccine would not be ready for use in West Africa until 2016, declaring testing of GlaxoSmithKline's product is likely to begin in healthcare and other front-line workers ...

22 October 2014

The European Medicines Agency 's policy on publication of trial data appears to be at odds, at least in spirit, with the broad direction of EU privacy law and the path ahead could potentially be strewn with litigation, a recent conference in India ...

22 October 2014

The Dutch government has made remote patient management - and the regulatory oversight of the products needed to achieve this objective ? a priority. Amanda Maxwell spoke with Dr Stefan Visscher at the Health Care Inspectorate (IGZ) to find out how ...

21 October 2014

The UK Medicines and Healthcare Products Regulatory Agency is inviting drug companies to test more widely a new scheme on co-ordinated submission and assessment of variations and changes to the packaging/patient information leaflet that are ...

22 October 2014

A top World Health Organization official has disputed reports that an Ebola vaccine would not be ready for use in West Africa until 2016, declaring testing of GlaxoSmithKline's product is likely to begin in healthcare and other front-line workers ...

22 October 2014

The European Medicines Agency 's policy on publication of trial data appears to be at odds, at least in spirit, with the broad direction of EU privacy law and the path ahead could potentially be strewn with litigation, a recent conference in India ...

22 October 2014

The Dutch government has made remote patient management - and the regulatory oversight of the products needed to achieve this objective ? a priority. Amanda Maxwell spoke with Dr Stefan Visscher at the Health Care Inspectorate (IGZ) to find out how ...

21 October 2014

The UK Medicines and Healthcare Products Regulatory Agency is inviting drug companies to test more widely a new scheme on co-ordinated submission and assessment of variations and changes to the packaging/patient information leaflet that are ...

22 October 2014

A top World Health Organization official has disputed reports that an Ebola vaccine would not be ready for use in West Africa until 2016, declaring testing of GlaxoSmithKline's product is likely to begin in healthcare and other front-line workers ...

22 October 2014

The European Medicines Agency 's policy on publication of trial data appears to be at odds, at least in spirit, with the broad direction of EU privacy law and the path ahead could potentially be strewn with litigation, a recent conference in India ...

22 October 2014

The Dutch government has made remote patient management - and the regulatory oversight of the products needed to achieve this objective ? a priority. Amanda Maxwell spoke with Dr Stefan Visscher at the Health Care Inspectorate (IGZ) to find out how ...

20 October 2014

The US has already moved ahead in implementing unique device identification requirements which help to identify medical devices through their distribution and use. In the EU, there is also growing demand for such a system but what is holding the ...

21 October 2014

The UK Medicines and Healthcare Products Regulatory Agency is inviting drug companies to test more widely a new scheme on co-ordinated submission and assessment of variations and changes to the packaging/patient information leaflet that are ...

15 October 2014

The Australian government will soon amend its regulations to allow most local medical device manufacturers to rely on conformity assessments by European notified bodies. The change is welcome news for the industry, which has long been pushing for a ...

15 October 2014

Johnson & Johnson/MSD's Remicade (infliximab) is to be made available to French patients for the unapproved indication of Takayasu's arteritis refractory to conventional drugs, under a temporary use recommendation (RTU) 1 . Remicade is the third ...

06 October 2014

All enterprises must disclose administrative penalty information in a timely manner or face a ban from public procurement, China has said. The rule could significantly change risk profiles for multinational healthcare companies in the country, say ...

06 October 2014

All enterprises must disclose administrative penalty information in a timely manner or face a ban from public procurement, China has said. The rule could significantly change risk profiles for multinational healthcare companies in the country, say ...

01 October 2014

GlaxoSmithKline's Chinese bribery scandal ? which last month ended with the UK major being fined a record sum of nearly $490 million ? has left the pharma industry pondering its next steps to meet a rising bar and the soaring costs of compliance 1 . ...

29 September 2014

The European Medicines Agency is hoping to get a final decision from its management board on 2 October on its eagerly-awaited policy on proactive publication of clinical trial data. If things go as planned, the policy could come into effect next ...

 
09 October 2014
Dr Peter Charlish
Personalized medicine may not yet be a reality but, as a meeting of the Society for Medicines Research heard in London last week 1 , considerable progress has nonetheless already been made towards that goal. In the UK, for example, a number of ...
 
11 February 2014
Maureen Kenny
?If you don?t finance it correctly, it will implode.? This was the stark warning key European drug ...
 
22 October 2014
The Republic of Moldova took a step forward in its pursuit of EU membership in June, when it signed ...
07 October 2014
Marcus Deans, Mark A De Rosch and Emmanuelle Voisin emphasize that having a combined regulatory and ...
07 October 2014
It may still be several years before the European Commission's proposed regulation for medical ...
 
 
12 November 2013
Joint assessments by national designating authorities in the EU of notified bodies active in the medical device area are relatively new. A voluntary ...
28 August 2013
Ken Daly looks to the US to predict what could happen in Europe if the European Commission's recommendation for an EU-wide class action system is ...
05 July 2013
The French medtech market is already highly regulated and complex and is becoming more so. While the CE marking should act as a single passport to ...
 
A candid look at the European drug regulatory network from Jytte Lyngvig, CEO of the Danish Medicines Agency 2000-2012
18 January 2013
 
US FDA's drugs center gets permanent regulatory policy head The US Food and Drug Administration has promoted Grail Sipes to permanent director of its Office of Regulatory Policy at ...
Law enforcement expert named as new compliance chief at US FDA drug center The US Food and Drug Administration has hired Cynthia Schnedar as the new head of compliance at its Center for Drug ...
 
   
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