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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-09.png606833Maurits J.F. Lugardhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaurits J.F. Lugard2022-07-01 13:01:352023-12-11 17:00:37New European Focus on Medicine Supply Chains Means More Disclosure
Due to COVID-19, many pharmaceutical manufacturing sites have not experienced a regulatory inspection in several years. Raj Pai discusses how to ensure that Good Manufacturing Practices are in place.
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. Pai2022-07-01 11:14:022022-09-21 11:08:44Making Manufacturing Sites Inspection-ready After the Pandemic Gap
Following our recent post highlighting potential compliance risks at emerging cellular and gene therapy companies, Stephen Abreu and Chris Fanelli provide some questions and topics to explore when considering an investment or acquisition in this space. (more…)
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Stephen Abreuhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngStephen Abreu2022-06-21 13:40:292022-06-21 13:44:57Key Questions To Ask When Conducting Due Diligence of an Emerging Cellular or Gene Therapy Company
Chris Fanelli explains how emerging cellular and gene therapy companies present unique challenges and unique opportunities from a compliance perspective. He explores some of the tools that buyers can use to assess GxP compliance at the due diligence and post-acquisition stages.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-05.png606833Christopher A. Fanellihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngChristopher A. Fanelli2022-06-10 11:38:022022-06-10 11:40:39Buyer Beware: Compliance Risks at Emerging Cellular and Gene Therapy Companies
Olivier Goarnisson in Geneva and Francesca Blythe in London look at the benefits that were seen when some European countries temporarily permitted remote monitoring during the pandemic, and consider whether remote monitoring might have a long-term future if data privacy concerns are addressed.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Olivier Goarnissonhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngOlivier Goarnisson2022-05-27 11:53:042022-10-12 13:41:16Might the Remote Monitoring of Clinical Trials in Europe Continue after Covid-19 Despite Data Privacy Concerns?
Maarten Meulenbelt explains why even companies headquartered in China or California need to be aware that the trend for ‘replacement pharmacy compounding’ may spread.
Over the last few years, the Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for pricing and reimbursement of the authorised products that they seek to replace. (more…)
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-15.png606833Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2022-04-27 15:15:492022-05-10 11:29:09Why International Pharma Companies Need to Watch What Is Happening in the Netherlands
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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
New European Focus on Medicine Supply Chains Means More Disclosure
Maurits Lugard and Anna-Shari Melin examine the new era of supply chain scrutiny and explain how the EMA’s new critical medicines lists will work.
(more…)
Maurits J.F. Lugard
Brussels
mlugard@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Making Manufacturing Sites Inspection-ready After the Pandemic Gap
Due to COVID-19, many pharmaceutical manufacturing sites have not experienced a regulatory inspection in several years. Raj Pai discusses how to ensure that Good Manufacturing Practices are in place.
Raj D. Pai
Washington, D.C.
rpai@sidley.com
Key Questions To Ask When Conducting Due Diligence of an Emerging Cellular or Gene Therapy Company
Following our recent post highlighting potential compliance risks at emerging cellular and gene therapy companies, Stephen Abreu and Chris Fanelli provide some questions and topics to explore when considering an investment or acquisition in this space. (more…)
Stephen Abreu
San Francisco
sabreu@sidley.com
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Buyer Beware: Compliance Risks at Emerging Cellular and Gene Therapy Companies
Chris Fanelli explains how emerging cellular and gene therapy companies present unique challenges and unique opportunities from a compliance perspective. He explores some of the tools that buyers can use to assess GxP compliance at the due diligence and post-acquisition stages.
(more…)
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Might the Remote Monitoring of Clinical Trials in Europe Continue after Covid-19 Despite Data Privacy Concerns?
Olivier Goarnisson in Geneva and Francesca Blythe in London look at the benefits that were seen when some European countries temporarily permitted remote monitoring during the pandemic, and consider whether remote monitoring might have a long-term future if data privacy concerns are addressed.
(more…)
Olivier Goarnisson
Geneva
ogoarnisson@sidley.com
Francesca Blythe
London
fblythe@sidley.com
Why International Pharma Companies Need to Watch What Is Happening in the Netherlands
Maarten Meulenbelt explains why even companies headquartered in China or California need to be aware that the trend for ‘replacement pharmacy compounding’ may spread.
Over the last few years, the Netherlands has begun to develop its own pharmacy-compounded products as an alternative to authorised products, and as a benchmark for pricing and reimbursement of the authorised products that they seek to replace. (more…)
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
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