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25 April 2014

 
25 April 2014

EU manufacturers may wish to consider phasing out the use of PVC in the manufacture of their medical devices, or risk exorbitant costs linked to unannounced audits by notified bodies of suppliers in far-flung places. This is the view of Andy ...

24 April 2014

The development costs for drugs could be slashed by as much as 90% and the time required to get new medicines "from bench to bedside" cut by half if the thresholds of approval were changed to look just at efficacy and fundamental safety, according ...

23 April 2014

The EMA has completed its inquiry into allegations that Roche failed to comply with its pharmacovigilance obligations regarding its 19 centrally authorized medicines, and has sent a report outlining its conclusions to the European Commission 1 . The ...

23 April 2014

Over half of non-compliance issues among the member companies of the European Association for Medical Devices of Notified Bodies (TEAM-NB) are related to qualification and assignment of notified body assessment personnel. That is the main finding ...

25 April 2014

EU manufacturers may wish to consider phasing out the use of PVC in the manufacture of their medical devices, or risk exorbitant costs linked to unannounced audits by notified bodies of suppliers in far-flung places. This is the view of Andy ...

24 April 2014

The development costs for drugs could be slashed by as much as 90% and the time required to get new medicines "from bench to bedside" cut by half if the thresholds of approval were changed to look just at efficacy and fundamental safety, according ...

23 April 2014

The EMA has completed its inquiry into allegations that Roche failed to comply with its pharmacovigilance obligations regarding its 19 centrally authorized medicines, and has sent a report outlining its conclusions to the European Commission 1 . The ...

23 April 2014

Over half of non-compliance issues among the member companies of the European Association for Medical Devices of Notified Bodies (TEAM-NB) are related to qualification and assignment of notified body assessment personnel. That is the main finding ...

24 April 2014

The development costs for drugs could be slashed by as much as 90% and the time required to get new medicines "from bench to bedside" cut by half if the thresholds of approval were changed to look just at efficacy and fundamental safety, according ...

23 April 2014

Over half of non-compliance issues among the member companies of the European Association for Medical Devices of Notified Bodies (TEAM-NB) are related to qualification and assignment of notified body assessment personnel. That is the main finding ...

17 April 2014

The European Parliament has voted in favor of the second Innovative Medicines Initiative (IMI2), a ?3bn public-private research partnership run jointly by the European Commission and the European Federation of Pharmaceutical Industries and ...

17 April 2014

Croatia is debating how to deal with a legislative requirement to remove certain batches of medicines from the market by 1 July, after finding that the deadline may be too short. The deadline is a transitional measure that came into effect when ...

23 April 2014

The EMA has completed its inquiry into allegations that Roche failed to comply with its pharmacovigilance obligations regarding its 19 centrally authorized medicines, and has sent a report outlining its conclusions to the European Commission 1 . The ...

17 April 2014

The European Parliament has voted through the EU regulation on fees payable by drug companies to the European Medicines Agency for conducting pharmacovigilance activities for medicines. A total of 544 MEPs voted in favor of the legislation, with 17 ...

16 April 2014

The International Conference on Harmonisation has issued a new Q&A document to clarify the guideline it finalized in November 2012 on periodic benefit-risk evaluation reporting (PBRER) on marketed medicines 1 ,2 . The Q&A document deals with a raft ...

11 April 2014

The Department of Health in the UK is planning to transferring the oversight of the system of issuing certificates of free sale (CFS) to medical device companies to the national medicines and healthcare products regulator, the MHRA, next year 1 ...

14 April 2014

A strong, science-based regulatory system, coverage and payment policies that value innovative medicines, and robust intellectual property (IP) rights and enforcement in the US and abroad are among the 10 policy areas senior-level biopharmaceutical ...

10 March 2014

The US Patent & Trademark Office has in its new guidelines for examining patent claims taken a broad interpretation of the Supreme Court's unanimous ruling last June that a naturally occurring DNA segment is a product of nature and not patent ...

06 March 2014

EU member state ministers have endorsed a compromise agreement on the jurisdiction of courts in what the European Commission describes as 'the last missing part' in the establishment of Europe-wide patent protection and a Unified Patent Court 1 . ...

 
08 April 2014
Ashely Yeo
Given the strides Zimmer?s David Dvorak made as chairman of US medtech industry trade association AdvaMed , he will be a hard act to follow. Implementation of MDUFA III , issuance of final unique device (UDI) guidance , putting the device tax ...
 
11 February 2014
Maureen Kenny
?If you don?t finance it correctly, it will implode.? This was the stark warning key European drug ...
 
23 April 2014
Should the EU wait for the introduction of the forthcoming EU IVD Regulation to regulate companion ...
22 April 2014
Cindy Hu, Shawn Shorrock, Yuling Hu and Seth J Goldenberg discuss sweeping new regulations for ...
04 April 2014
Despite the existence of legislation in the US and the EU mandating the carrying out of pediatric ...
 
MOST READ
 
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
 
Howard Sklamberg, drugs compliance director at US FDA, takes on global role at agency Howard Sklamberg, the director of the Office of Compliance at the US Food and Drug Administration?s drugs center CDER, is ...
Who's moving where. Click here for news of the latest personnel moves in the world of pharmaceutical and medical device regulatory affairs ...
 
EVENTS
May 14 2014
Sheraton Brussels Hotel | Brussels | Belgium
May 14 2014
The Hotel. Brussels, Brussels, Belgium
May 21 2014
Leonardo Royal Hotel Berlin AlexanderplatzOtto-Braun-Strasse 90D-10249 Berlin
   
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