Elisabethann Wright

Elisabethann Wright

Hogan Lovells

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EMA public consultation on revised policy on access to documents

The EMA has launched a public consultation on its draft new Policy/0043 on access to documents. The document describes the EMA’s approach in balancing public and private interests involved in requests for access to documents...more

3/20/2017 - Comment Period Documentation EU European Medicines Agency (EMA) Pharmaceutical Industry Regulatory Standards

EU - US mutual recognition of GMP inspections: agreement published

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU:...more

3/20/2017 - EU Manufacturers Mutual Recognition Agreement Pharmaceutical Industry Regulatory Standards

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are...

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”)....more

2/24/2017 - Certification Requirements EU EU Directive Medical Devices Pharmaceutical Industry

Extension to the EMA's Multinational Assessment Team Initiative as of April 2017

Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national...more

2/21/2017 - EU European Medicines Agency (EMA) Marketing Pharmaceutical Industry Prescription Drugs Regulatory Oversight UK UK Brexit

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more

2/3/2017 - Disclosure Requirements EU France Healthcare Manufacturers Medical Devices Pharmaceutical Industry Regulatory Standards

EMA pilot project on tailored scientific advice to support new biosimilars

In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a...more

2/3/2017 - Biosimilars Biotechnology EU European Medicines Agency (EMA) Pharmaceutical Industry Regulatory Standards

EMA Update concerning EU Clinical Trials portal and database

Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was adopted and entered into force in 2014. The...more

1/30/2017 - Biotechnology Clinical Trials Databases EU Pharmaceutical Industry Portal Training

EMA post-authorisation procedural advice for users of the centralised procedure

On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of the centralised procedure (“the guidance...more

1/30/2017 - Applications EU European Medicines Agency (EMA) Pharmaceutical Industry Regulatory Oversight

EMA hosts workshop on adaptive pathways

On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach. The aim...more

1/10/2017 - Biotechnology Data Use Policies EU European Medicines Agency (EMA) Healthcare Patient Access Pharmaceutical Industry

EMA on optimising the development of advanced therapies

On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory conference concerning the optimisation of the development of...more

1/10/2017 - Biopharmaceutical EU European Medicines Agency (EMA) Healthcare Human Genes Patient Access Patients Pharmaceutical Industry Regulatory Standards

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