A new Executive Order in the U.S. aims to ease the path to market for products that use synthetic biology or genome editing. Emily Marden explains the thinking behind the announcement and its efforts to streamline the current U.S. framework for biotech.
Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory Assessments.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Christopher A. Fanellihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChristopher A. Fanelli2022-11-10 10:04:432022-11-28 11:54:44Remote Regulatory Assessment Oversight Tools Piloted During the COVID-19 Pandemic Are Here to Stay
Justine Fassion considers how the various sanctions against Russia are impacting pharmaceutical supply chains, and explains why pharma companies will be affected despite the existence of humanitarian exceptions.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-12.png606833Justine Fassionhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJustine Fassion2022-10-25 12:08:062022-10-25 12:45:31Unprecedented Sanctions Against Russia Continue to Impact Pharma Supply Chains
Jay Jariwala in Washington, D.C. and Josefine Sommer in Brussels talk to Raj Pai about how they expect the EU’s new revised Annex 1, EudraLex Volume 4 (GMP), to affect the manufacturing of sterile medicinal products. They discuss how the update reflects changes in the manufacturing environment and how the new Annex 1 is likely to be considered within the U.S. regulatory framework. Prior to joining Sidley, Jay worked for the Office of Compliance at the Center for Drug Evaluation and Research, a branch of the U.S. Food and Drug Administration, and he brings this experience to bear in considering the impact of Annex 1.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Raj D. Paihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngRaj D. Pai2022-10-17 17:05:042022-10-17 17:05:59Podcast: How the EU’s New Revised Annex 1, Eudralex Volume 4 (GMP), Will Affect the Manufacturing of Sterile Medicinal Products in the EU and U.S.
Eva von Mühlenen and Alejandro Bes of Novartis consider how the proposed European Health Data Space may speed up research for medicinal products by increasing access to health data, with the help of data scientists within the EU. This development is likely to generate five sticking points that the life sciences industry will need to address, they add.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-14.png606833Eva von Mühlenenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngEva von Mühlenen2022-10-05 11:04:032023-02-08 10:53:42Could the European Health Data Space Push the EU Above Other Key Markets Such As the U.S. and China?
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 11:11:322022-10-12 13:41:09Why Companies Globally Should Start Preparing Now for the European Health Data Space
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Biden Administration Moves to Boost the Bioeconomy
A new Executive Order in the U.S. aims to ease the path to market for products that use synthetic biology or genome editing. Emily Marden explains the thinking behind the announcement and its efforts to streamline the current U.S. framework for biotech.
Emily Marden
San Francisco
emarden@sidley.com
Remote Regulatory Assessment Oversight Tools Piloted During the COVID-19 Pandemic Are Here to Stay
Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory Assessments.
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Unprecedented Sanctions Against Russia Continue to Impact Pharma Supply Chains
Justine Fassion considers how the various sanctions against Russia are impacting pharmaceutical supply chains, and explains why pharma companies will be affected despite the existence of humanitarian exceptions.
Justine Fassion
Brussels
justine.fassion@sidley.com
Podcast: How the EU’s New Revised Annex 1, Eudralex Volume 4 (GMP), Will Affect the Manufacturing of Sterile Medicinal Products in the EU and U.S.
Jay Jariwala in Washington, D.C. and Josefine Sommer in Brussels talk to Raj Pai about how they expect the EU’s new revised Annex 1, EudraLex Volume 4 (GMP), to affect the manufacturing of sterile medicinal products. They discuss how the update reflects changes in the manufacturing environment and how the new Annex 1 is likely to be considered within the U.S. regulatory framework. Prior to joining Sidley, Jay worked for the Office of Compliance at the Center for Drug Evaluation and Research, a branch of the U.S. Food and Drug Administration, and he brings this experience to bear in considering the impact of Annex 1.
Raj D. Pai
Washington, D.C.
rpai@sidley.com
Jay Jariwala
Washington, D.C.
jjariwala@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Could the European Health Data Space Push the EU Above Other Key Markets Such As the U.S. and China?
Eva von Mühlenen and Alejandro Bes of Novartis consider how the proposed European Health Data Space may speed up research for medicinal products by increasing access to health data, with the help of data scientists within the EU. This development is likely to generate five sticking points that the life sciences industry will need to address, they add.
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
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.
Arif 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
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