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2021

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Articles 361 - 365 of 365

Full-Text Articles in Science and Technology Law

From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham Jan 2021

From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham

Articles, Book Chapters, & Popular Press

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …

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Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder Jan 2021

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

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Consultation On How To Implement Canada's Cusma Commitment To Extend The General Term Of Copyright Protection, Carys Craig, Ariel Katz, Lucie Guibault, Graham Reynolds, Bita Amani, Sara Bannerman, Pascale Chapdelaine, Myra Tawfik, Samuel Trosow Jan 2021

Consultation On How To Implement Canada's Cusma Commitment To Extend The General Term Of Copyright Protection, Carys Craig, Ariel Katz, Lucie Guibault, Graham Reynolds, Bita Amani, Sara Bannerman, Pascale Chapdelaine, Myra Tawfik, Samuel Trosow

Articles, Book Chapters, & Popular Press

As a group of Canadian Intellectual Property Law scholars, we write regarding the Ministers’ recently launched consultation on extending the term of copyright protection in order to meet Canada’s CUSMA commitments. With this letter, which we jointly submit in response to the call for comments, we wish to express our shared concerns about both the proposed term extension and, more immediately, the inappropriately curtailed nature of this consultation process.

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Reasonable Expectations Of Privacy In An Era Of Drones And Deepfakes: Expanding The Supreme Court Of Canada’S Decision In R V Jarvis, Suzie Dunn, Kristen Mj Thomasen Jan 2021

Reasonable Expectations Of Privacy In An Era Of Drones And Deepfakes: Expanding The Supreme Court Of Canada’S Decision In R V Jarvis, Suzie Dunn, Kristen Mj Thomasen

Articles, Book Chapters, & Popular Press

Perpetrators of Technology-Facilitated gender-based violence are taking advantage of increasingly automated and sophisticated privacy-invasive tools to carry out their abuse. Whether this be monitoring movements through stalker-ware, using drones to non-consensually film or harass, or manipulating and distributing intimate images online such as deep-fakes and creepshots, invasions of privacy have become a significant form of gender-based violence. Accordingly, our normative and legal concepts of privacy must evolve to counter the harms arising from this misuse of new technology. Canada’s Supreme Court recently addressed Technology-Facilitated violations of privacy in the context of voyeurism in R v Jarvis (2019). The discussion of …

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Is It Actually Violence? Framing Technology-Facilitated Abuse As Violence, Suzie Dunn Jan 2021

Is It Actually Violence? Framing Technology-Facilitated Abuse As Violence, Suzie Dunn

Articles, Book Chapters, & Popular Press

When discussing the term “Technology-Facilitated violence” (TFV) it is often asked: “Is it actually violence?” While international human rights standards, such as the United Nations’ Convention on the Elimination of All Forms of Discrimination against Women, have long recognized emotional and psychological abuse as forms of violence, including many forms of technology-facilitated abuse, law makers and the general public continue to grapple with the question of whether certain harmful technology-facilitated behaviors are actually forms of violence. This chapter explores this question in two parts. First, it reviews three theoretical concepts of violence and examines how these concepts apply to technology-facilitated …

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