Publications

Hogan Lovells Publications

Connecting Europe - False advertising in life sciences

In view of the success of our first edition of “False Advertising in Life Sciences”, we are proud to introduce our second edition which is even more thorough.

Publications

Digital Health: CE marking of medical devices

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of ...

Hogan Lovells Publications

Indictment in US$40m alleged fraud case signals increased scrutiny of SDVOSB government contractors

On December 1, 2017, the U.S. Department of Justice announced the federal grand indictment of an army veteran for allegedly engaging in major government program fraud by using his status as ...

Published Works

Keeping the chemistry right between the UK and Europe after Brexit

Ministers are making the right noises about our relationship with EU science bodies, but questions remain, says Elisabethann Wright.

Publications

FDA, EU regulators agree to share unredacted inspection reports and other confidential information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which...

Blog Post

EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation....

Blog Post

Personalised Medicines at the top of the European Agenda

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published.

The workshop discussed the views of ...

Publications

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of...

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