Talking the Cure by Hogan Lovells

Talking the Cure: Discussing COVID-19’s impact on FDA’s inspection program and next steps after the pandemic

In this episode, Phil Katz and Jim Johnson continue their conversation about the impact of COVID-19 on FDA’s drug inspection program and the steps companies should take now and in preparation for when the pandemic is coming to an end.
For all updates around COVID-19, visit our COVID-19 hub.
You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.
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Talking The Cure: Discussing how the coronavirus pandemic is affecting the pharmaceutical industry and FDA

In this episode, Phil Katz, David Horowitz, and Jim Johnson explore the impact on industry and FDA of the agency’s decision to halt foreign inspections and take other steps that reduce international activities. They anticipate further steps by the agency and talk about how companies can strategically address the implications, which create obstacles but also opportunities.

Talking The Cure: Discussing FDA authorities for handling a global pandemic for medical devices

In this episode, Michael S. Heyl and Jonathan S. Kahan explore questions around FDA’s Emergency Use Authorization authorities, how it has been used historically, and how it may be used for the coronavirus. They highlight very recent FDA actions and project how these authorities could be applied to address supply chain issues, in addition to the development of new technologies/devices to aid in the diagnosis and treatment of the virus.

Talking the Cure: Discussing the supply chain and its potential downfalls

In this episode, Arne Thiermann and Mike Druckman explore questions around the supply chain in the life sciences and health care industry. They highlight the reality and the expectation when it comes down to the draft of a contract in this kind of situations.
You can find additional thought leadership and information regarding Medical Devices and Technology Regulatory on HL Engage.
If you are interested in more information all around Life Sciences and Health Care, follow us on LinkedIn and Twitter.

Talking The Cure: Exploring the industry with Jörg Schickert

In this episode, Jörg Schickert, one of the leading life sciences and health care lawyers for regulatory and commercial issues in Europe, is going to talk about his work, his views on the industry, and why he wouldn't change anything if he had the chance to start his journey all over again.

Talking The Cure: Discussing the use of digital tools in clinical trials

In this episode, Elisabethann Wright and Robert F. Church from our Global Regulatory practice explore questions around the use of digital tools in clinical trials and how they are regulated by international authorities. They highlight the confusion around clinical trials within the European GDPR framework.
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