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Nov 11, 2024 | 
mondaq.com | Alexander Roussanov
In the last month, both the European Data Protection Board
("EDPB") and the Court of Justice of the European Union
("CJEU") provided their interpretation of key data
protection concepts that are crucial for ensuring compliance with
Regulation (EU) 2016/679
("GDPR").
In Opinion 22/2024, the EDPB provided guidance to
data controllers on how to effectively oversee the activities of
their (sub-)processors in a GDPR-compliant manner.
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Oct 8, 2024 | 
mondaq.com | Jackie Mulryne |Alexander Roussanov |Eftychia Sideri
AP
Arnold & Porter
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Arnold & Porter is a firm of more than 1,000 lawyers, providing sophisticated litigation and transactional capabilities, renowned regulatory experience and market-leading multidisciplinary practices in the life sciences and financial services industries. Our global reach, experience and deep knowledge allow us to work across geographic, cultural, technological and ideological borders.
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Sep 24, 2024 | 
mondaq.com | Jackie Mulryne |Alexander Roussanov |Eftychia Sideri
On 5 September 2024, the European Medicines Agency (EMA) and the
Heads of Medicine Agencies (HMA) published a guidance document (the Guidance) with general
principles and recommendations on the use of large language models
(LLMs) in regulatory science and the regulation of medicinal
products. The guiding principles for users are also summarised in a
one-page factsheet.
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May 2, 2024 | 
mondaq.com | Camille Vermosen |Alexander Roussanov
On April 10, 2024, the European Parliament (EP) voted on its
amendments to the European Commission's (EC) July 4, 2023
proposal for a GDPR Enforcement Regulation (the Proposal). While the EC's Proposal aimed to streamline and expedite
enforcement procedures in cross-border cases, some of the EP's
amendments have introduced complexities that might be important for
global companies, especially those processing sensitive personal
data, such as health data.
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Apr 18, 2024 | 
mondaq.com | Jackie Mulryne |Alexander Roussanov
Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the
pharmaceutical reform package following a debate on 10 April.
The vote is a key step in the passage of the new Directive and
Regulation, which together form the EU's revisions to the
General Pharmaceutical Legislation (GPL).
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Apr 15, 2024 | 
lexblog.com | Jackie Mulryne |Alexander Roussanov
Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April. The vote is a key step in the passage of the new Directive and Regulation, which together form the EU’s revisions to the General Pharmaceutical Legislation (GPL).
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Apr 15, 2024 | 
biosliceblog.com | Jackie Mulryne |Alexander Roussanov
Members of the European Parliament (MEPs) have voted overwhelmingly in favour of the pharmaceutical reform package following a debate on 10 April. The vote is a key step in the passage of the new Directive and Regulation, which together form the EU’s revisions to the General Pharmaceutical Legislation (GPL).
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Nov 14, 2023 | 
mondaq.com | Jackie Mulryne |Alexander Roussanov |Sean Curran
Inspections and
Investigations in the EU and UK from Arnold &
Porter on Vimeo.
GxP compliance is essential for life sciences companies, and the
EU and UK competent authorities are as active as ever. Please join
Jackie Mulryne, Alexander Roussanov, and Sean Curran, partners at
Arnold & Porter, to learn about the latest developments in the
EMA and MHRA's approach to GxP inspections.
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Oct 10, 2023 | 
mondaq.com | Alexander Roussanov
In September 2023, the European Medicines Agency (EMA)
relaunched its Policy 0070 on publication of clinical data
for medicinal products for human use (the Policy). The Policy, as
discussed in previous posts, is one of the Agency's flagship
public health initiatives focused on promoting the transparency of
both EMA decision-making and clinical data, sharing of knowledge
and use in future research.
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Jul 27, 2023 | 
mondaq.com | Jackie Mulryne |Alexander Roussanov |Eftychia Sideri
On 19 July 2023, the European Medicines Agency (EMA) published a
draft Reflection paper on the use of artificial
intelligence (AI) in the lifecycle of medicines (the Paper). The Paper recognises the value of this technology as part of the
digital transformation within healthcare, and acknowledges its
increasing use and potential to "support the acquisition,
transformation, analysis, and interpretation of data within the
medicinal product lifecycle", provided of course it is
"used correctly".
