Elisabethann Wright

Firm/Organization: Hogan Lovells

Latest Articles

EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation

By Patrice Navarro & Elisabethann Wright on May 1, 2019

Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of clinical trials. The GDPR¹ could not fully harmonize these rules since this area is already heavily regulated by public health regulations that vary between EU Member States. One of the most disconcerting areas of divergence between EU Member States is the different national…

HL Chronicle of Data Protection

EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation

By Patrice Navarro & Elisabethann Wright on April 25, 2019

Focus on Regulation

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

By Elisabethann Wright & Alexander Wenzel on January 25, 2019

Introduction The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities responsible for the procurement of (in vitro) medical devices with guidance concerning Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR). This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the…

Focus on Regulation

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

By Elisabethann Wright & Alexander Wenzel on January 23, 2019

Introduction On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are currently applicable. They provide guidance for the clinical development and quality control of medicinal products containing allergens. All of these guidelines start from the premise that the population of the clinical trial is large enough to gather adequate data. The goal of…

Focus on Regulation

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent authorities

By Elisabethann Wright & Alexander Wenzel on January 8, 2019

Introduction The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the implications of the Medical Device Regulation (MDR) and the In Vitro Medical Device Regulation (IVDR). The factsheet is intended to facilitate the import into the EU and export of medical devices from the EU during the transition period.…

Focus on Regulation

The European Commission started implementing its “no-deal Brexit” Contingency Action Plan

By Elisabethann Wright & Alexander Wenzel on January 7, 2019

Introduction On 19 December 2018, the European Commission published a Communication addressed at the EU institutions. The Communication relates to the preparation for the withdrawal of the United Kingdom from the European Union, in case of a “no-deal” Brexit. The Communication discussed 14 measures that the European Commission has adopted to prepare for the “no-deal” Brexit scenario.…

Focus on Regulation

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

By Elisabethann Wright & Alexander Wenzel on December 13, 2018

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products.[1] The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation of haemophilia B medicinal products. In July, a similar guideline was adopted concerning haemophilia A medicinal products. The draft describes data that needs to be collected during clinical trials for a haemophilia B medicinal product prior…

Focus on Regulation

EMA publishes draft guideline on the quality of water for pharmaceutical use

By Elisabethann Wright & Alexander Wenzel on December 6, 2018

Introduction The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use. New methods that are equivalent to the distillation for water will be included in the guideline. The guidance provided by the draft should also be…

Focus on Regulation

EMA launches public consultation on the use of patient disease registries for regulator purposes

By Elisabethann Wright & Alexander Wenzel on November 28, 2018

Introduction On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries Initiative (PRI). The consultation period is open to stakeholders until 29 June 2019. It has been published to allow stakeholders to participate in the discussion by commenting on the paper.…

Focus on Regulation

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

By Elisabethann Wright & Alexander Wenzel on November 26, 2018

Introduction The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric population came into effect on 8 November 2018. The Considerations Chapter addressed pharmacovigilance issues that frequently arise with the paediatric population and related pharmacovigilance structures and processes. It provides guidance on how to make use of existing tools and processes specifically regarding the paediatric…

Elisabethann Wright

EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation

EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent authorities

The European Commission started implementing its “no-deal Brexit” Contingency Action Plan

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

EMA publishes draft guideline on the quality of water for pharmaceutical use

EMA launches public consultation on the use of patient disease registries for regulator purposes

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

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