Searching Content from Ireland indexed under Life Sciences, Biotechnology & Nanotechnology ordered by Published Date Descending.
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Life Sciences Update: Outlook For 2019 And Post-Brexit Implications
2019 has started with a flurry of large M&A deals in the Life Sciences sector.
26 Feb 2019
Public Procurement Case Law Update: Sanofi v HSE
Life Sciences businesses eagerly awaited the High Court judgment of 12 October on Sanofi v HSE.
26 Oct 2018
Portable Products: Moving Your Marketing Authorisations Or CE Marks To Ireland
Changing political and legal landscapes are prompting life sciences companies to review the location of their regulatory authorisations.
European Union
16 Oct 2018
Multi-Party Actions Bill 2017- A Healthcare Perspective
The Multi-Party Actions Bill 2017 (the "2017 Bill") was introduced on 9 November 2017 with the aim of reducing the cost of litigation, providing greater access to the courts and allowing the resources...
11 Jan 2018
Brexit And The Irish Life Sciences Industry
As the largest net exporter of pharmaceuticals in the EU and one of the largest in the world and given that most of the world's largest pharmaceutical and medical device companies...
4 Oct 2017
Dublin – Where The World Comes To Work #DublinforEMA
Ireland submitted its formal bid on 31 July 2017 for Dublin to become the future location of the European Medicines Agency ("EMA") following Brexit.
7 Sep 2017
HPRA Revisits E-Cigarette Guidance
In the Guide, the HPRA includes a new definition for e-cigarettes which, unlike the previous version of the Guide, further elaborates on the type of chambers in these products...
13 Jun 2017
New EU Medical Device Regulations Adopted By European Parliament
The new EU Medical Device Regulations were adopted by the European Parliament on 6 April 2017.
European Union
13 Apr 2017
Post Market Surveillance Will Now Require Periodic Updates
The new EU Medical Device Regulations, which are due to be voted on by the European Parliament, will result in increased post market surveillance and vigilance requirements for medical device manufacturers.
7 Apr 2017
Knowledge Bites, Part 3: How Does The New Scrutiny Procedure Look?
The new Medical Device Regulations, whose final drafts were published by the Council of the European Union last week, will result in an additional layer of review of technical documentation...
10 Mar 2017
Knowledge Bites, Part 1: Unannounced Audits – New Medical Device Regulations
Arthur Cox is pleased to present the first of a series of knowledge bites to prepare medical device manufacturers for the new EU medical device regulations...
8 Feb 2017
HPRA Opens New Innovation
The Health Products Regulatory Authority (the "HPRA") has established an Innovation Office (the "Office") aimed at supporting the development of novel products in the life sciences sector.
20 Jan 2017
IPHA And The Government Finally Reach Agreement On The Supply And Pricing Of Medicines In Ireland
On 20 July 2016, following much debate and lengthy negotiations, the Irish Government, the HSE and the IPHA signed the Framework Agreement on the Supply and Pricing of Medicines.
22 Aug 2016
Thinking Of Ireland Post-Brexit?
In the post-Brexit climate, Ireland's position as an English speaking gateway to one of the world's largest markets will be even more significant than in the past.
28 Jul 2016
White Smoke Emerges: New Medical Device Regulations Finally Published
Initiated against the backdrop of the well-documented PIP breast implant issues, the new Regulations have been the subject of rigorous scrutiny and comment for the past four years.
22 Jun 2016
Public And Administrative Law Update: Clinical Trials In Ireland And Changing Legislation
Before any medicinal product is given permission to access the Irish market, it must be first tested in a clinical trial to verify that it is safe and fit for use.
28 Aug 2015
The Proposed EU Data Protection Regulation: Implications For The Life Sciences Sector
The Regulation could adversely affect the life sciences industry and is perhaps the most important piece of proposed European legislation in many decades for the industry.
European Union
17 Jul 2015
Guide To Pricing And Reimbursement Of Medicinal Products For Human Use
Colin Kavanagh, Head of the Life Sciences Group at Arthur Cox, discusses the current status of pricing and reimbursement of medicinal products for human use in Ireland, commonly of interest to companies. This practical comparative guide was first published by Conférence Bleue, a network of highly renowned lawyers specialising in pharmaceutical and health care law that meet regularly to exchange information.
6 Jul 2015
Clinical Trials – Developments Within The EU
Currently, the conduct of clinical trials in the EU is regulated by the Clinical Trials Directive (Directive 2001/20/EC) which sets out the laws, regulations and administrative provisions.
European Union
1 Dec 2014
Proposals To Extend R&D Protection Against Patent Infringement For Companies In The Pharmaceutical Sector
On 31 July 2014, the Irish legislature published the Intellectual Property (Miscellaneous Provisions) Bill 2014.
16 Oct 2014
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