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China's emerging data protection laws bring challenges for conducting investigations in China
By Sammy Fang Han Liang
In recent years, China has introduced a number of major data protection laws, including the Personal Information Protection Law (PIPL)...
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Podcast: UPC on the go – Practical advice on the Unified Patent Court
By Markus Gampp
A new international court is coming. Are you ready? 2023 will see the launch of the much awaited Unified Patent Court and Unitary Patent....
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European Commission proposes new rules on blood, tissues, and cells
By Marco de Morpurgo Nicola Landolfi
Today, the European Commission adopted a proposal for a new Regulation on standards of quality and safety for substances of human origin...
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UK: New National Strategy for Health Data
By James Clark
The UK’s Department for Health and Social Care (“DHSC”) has published a major strategy document (‘Data saves lives: reshaping health and...
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Coming EU legislation will change the AI regulatory environment for healthcare technology and life sciences companies
By Coran Darling Mark O'Conor Danny Tobey
The proposed EU AI Regulation, a comprehensive regime for the purposes of regulating AI in the EU, is set to impact organizations around...
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European Commission adopts additional rules for the application of In Vitro Diagnostic Regulation
By Mariana Ricardo
The European Commission recently adopted two new regulations laying down rules for the application of Regulation (EU) 2017/746, as...
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IFPMA issues principles encouraging ethical use of AI in healthcare
By Coran Darling
Use of AI in healthcare continues to solidify itself as a solid practice for the benefit of patients and healthcare providers. No more...
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The Brazilian Federal Council of Pharmacy regulates telepharmacy
By Bruna Rocha Juliana Marcondes Victoria Cristofaro
Last Thursday (30 June), the Federal Council of Pharmacy approved a resolution that regulates telepharmacy in Brazil. The new regulation,...
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Life Sciences update for Ireland: Watch out for major changes to the competition rules
By Darach Connolly
On 29 June 2022, Ireland enacted major reforms to its Competition Act.  These changes could have a significant impact across most sectors...
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Sweden to implement a new Biobanks Act
By Fredrika Allard
The Swedish government has decided to implement a new Biobanks Act, which is suggested to enter into force on 1 July 2023.   The current...
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Luxembourg draft bill on recreational cannabis
By David Alexandre Benoîte Chanfray Camille Malécot
Following the Luxembourg government's clarifications of October 2021, the Council of Government has recently approved the draft bill on...
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FDA Warning Letter focuses on GMP failures at 503B compounding outsourcing facility
By Bethany Hills Hilary Hoffman
After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA...
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Summer of 2022; the dawn of the behemoth, Haleon plc
By Robert Newman
Think back almost four years to December 2018. A certain Donald Trump was POTUS, Theresa May survived a vote of no confidence (by a vote...
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Spain’s Medical Device Market to recover in 2022
By Elisa Lorenzo
Fitch Solutions Country Risk & Industry Research has published a report confirming that the Spain’s medical devices market will see...
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The Brazilian Minister of Health approves the Ordinance regulating telehealth in Brazil
By Bruna Rocha Juliana Marcondes Victoria Cristofaro
Last Thursday (2 June, 2022), Marcelo Queiroga – president of the Brazilian Society of Cardiology and current Minister of Health –...
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The Federal Council of Nursing regulates the exercise of Telenursing - Brazil
By Bruna Rocha Juliana Marcondes Victoria Cristofaro
Last week, the Federal Council of Nursing (in Portuguese, “Conselho Federal de Enfermagem” or simply “COFEN”) approved the Resolution...
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