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Elisabethann Wright

Hogan Lovells

Legal Influencer

Q4 | 2018

Lexology Awards

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  • Q4 | 2018 in Healthcare and life sciences - Cross-border


Results 1 to 5 of 194
Most popular |Most recent

What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

European Union - October 14 2019 The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture)...

Grégoire Paquet.

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

United Kingdom, European Union - October 1 2019 On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and...

Grégoire Paquet.

New drug marketing applications: how do EMA and FDA compare?

USA - September 18 2019 A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and...

Grégoire Paquet.

European Medicines Agency’s clarification regarding re-testing exemption for imported advanced therapy medicinal products

European Union - September 6 2019 On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP)...

Grégoire Paquet.

Derogation procedures in the light of Brexit

Luxembourg, Poland, Austria, Spain, United Kingdom, Belgium, European Union, France, Germany, Greece, Ireland, Italy - September 4 2019 With the anticipated departure of the United Kingdom from the EU, medical device manufacturers are exploring whether it will be possible to continue...

Alexander Wenzel, Grégoire Paquet.