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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Arthur Cox ordered by Published Date Descending.
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Date
1
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
2
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...
Ireland
4 Oct 2017
3
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...
Ireland
13 Jun 2017
4
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
5
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.
Ireland
7 Apr 2017
6
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...
Ireland
10 Mar 2017
7
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...
Ireland
8 Feb 2017
8
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.
Ireland
20 Jan 2017
9
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.
Ireland
22 Aug 2016
10
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.
Ireland
22 Jun 2016
11
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.
Ireland
6 Jul 2015
12
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
13
PLC Life Sciences Multi-Jurisdictional Guide 2013 (Ireland Chapter)
What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?
Ireland
3 Jun 2013
14
PLC Life Sciences Multi-Jurisdictional Guide 2012
What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?
Ireland
22 May 2012
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