With many pharmaceutical manufacturing facilities unaccustomed to in-person GMP inspections since the pandemic, Arif Noorani, Josefine Sommer, and Daniel Roberts examine how inspection techniques have evolved.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Arif S. Nooranihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngArif S. Noorani2022-09-21 11:06:182022-09-21 11:06:41The Top Three Pandemic Manufacturing Inspection Techniques That Are Here to Stay
Zina Chatzidimitriadou and Francesca Blythe explain how a revolutionary EU regulation, expected to come into force in 2025, will allow life sciences companies to request health data for secondary re-use, but will also expose them to more data requests.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/09/MN-13110_WTO-Webinar-Event-Images_505x295.jpg295505Zina Chatzidimitriadouhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngZina Chatzidimitriadou2022-09-02 11:11:322022-09-02 11:11:32Why Companies Globally Should Start Preparing Now for the European Health Data Space
Stephen Abreu explains how licensors can make sure they do not give a licensee unintended rights to biological targets arising out of their own internal research, or from separate collaborations with third parties.
At our recent Digital Health App’ero, Zina Chatzidimitriadou led a discussion with key industry players Aleksandra Appelfeld of Philips and Megan Coder of the Digital Therapeutics Alliance on what changes the industry would like to see in order to make Europe more hospitable to digital health products. We set out the top five themes that emerged, and a space to watch for the next decade.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Zina Chatzidimitriadouhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngZina Chatzidimitriadou2022-08-01 11:21:542022-08-01 11:21:54How to Create a More Enabling Environment for Digital Health in Europe
Scott Bass explains why taking a multi-disciplinary, multi-continent approach to the planning of clinical trials will help you anticipate regulatory changes and ward off investigations.
Sidley’s Eva von Mühlenen in Geneva and Josefine Sommer in Brussels talk to oncologist Wolfgang Hackl — the founder of a FemTech startup that guides doctors in the treatment of breast cancer — about regulation, research and development (R&D), and the vast potential of artificial intelligence in the field of health technology for women. (more…)
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Eva von Mühlenenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngEva von Mühlenen2022-07-12 11:37:102022-07-12 11:37:10The Challenges Facing Artificial Intelligence and Machine Learning Solutions in the FemTech Space
Torrey Cope looks at the recent FDA emphasis on the challenges of a China-only trial strategy. He explores the FDA concern that a China-only clinical trial will be unable to prove that a drug is suitable for the U.S. population, and considers the regulatory requirements for U.S. approvals based on ex-U.S. trial data.
The Top Three Pandemic Manufacturing Inspection Techniques That Are Here to Stay
With many pharmaceutical manufacturing facilities unaccustomed to in-person GMP inspections since the pandemic, Arif Noorani, Josefine Sommer, and Daniel Roberts examine how inspection techniques have evolved.
GMPArif S. Noorani
Washington, D.C.
anoorani@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Daniel J. Roberts
San Francisco
droberts@sidley.com
Why Companies Globally Should Start Preparing Now for the European Health Data Space
Zina Chatzidimitriadou and Francesca Blythe explain how a revolutionary EU regulation, expected to come into force in 2025, will allow life sciences companies to request health data for secondary re-use, but will also expose them to more data requests.
(more…)
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Francesca Blythe
London
fblythe@sidley.com
‘Ring-fencing’ Biological Targets in Collaboration Agreements
Stephen Abreu explains how licensors can make sure they do not give a licensee unintended rights to biological targets arising out of their own internal research, or from separate collaborations with third parties.
GxP Transactions, Licensing AgreementsStephen Abreu
San Francisco
sabreu@sidley.com
How to Create a More Enabling Environment for Digital Health in Europe
At our recent Digital Health App’ero, Zina Chatzidimitriadou led a discussion with key industry players Aleksandra Appelfeld of Philips and Megan Coder of the Digital Therapeutics Alliance on what changes the industry would like to see in order to make Europe more hospitable to digital health products. We set out the top five themes that emerged, and a space to watch for the next decade.
(more…)
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
Five Global Bellwether Trends for Clinical Trials
Scott Bass explains why taking a multi-disciplinary, multi-continent approach to the planning of clinical trials will help you anticipate regulatory changes and ward off investigations.
Clinical Trials, RegulatoryScott Bass
New York, Washington, D.C.
sbass@sidley.com
The Challenges Facing Artificial Intelligence and Machine Learning Solutions in the FemTech Space
Sidley’s Eva von Mühlenen in Geneva and Josefine Sommer in Brussels talk to oncologist Wolfgang Hackl — the founder of a FemTech startup that guides doctors in the treatment of breast cancer — about regulation, research and development (R&D), and the vast potential of artificial intelligence in the field of health technology for women. (more…)
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Are China-only Clinical Trials Enough for U.S. Approvals?
Torrey Cope looks at the recent FDA emphasis on the challenges of a China-only trial strategy. He explores the FDA concern that a China-only clinical trial will be unable to prove that a drug is suitable for the U.S. population, and considers the regulatory requirements for U.S. approvals based on ex-U.S. trial data.
(more…)
Torrey Cope
Washington, D.C.
tcope@sidley.com
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