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Events

PRIM&R's 2019 Advancing Ethical Research Conference

November 17-20, 2019
Kate Gallin Heffernan, Marylana Saadeh Helou
Boston, MA

Attorneys Kate Heffernan and Marylana Saadeh Helou will present at PRIM&R’s 2019 Advancing Ethical Research Conference in Boston, November 17-20. Their presentations will address research risks in the age of comparative effectiveness research and alternative trial design, regulations pertaining to research misconduct and human subjects protections, as well as operationalizing research databases and biobanks.

To view the conference's agenda, click here.

Firm Highlights

Publication/Podcast

Due to COVID-19, Federal Agencies Relax Requirements Regarding the Provision of Telehealth Services

In the past few days, in an effort to help keep Medicare beneficiaries healthy during the COVID-19 pandemic, key federal agencies within the U.S. Department of Health and Human Services (“HHS”) and the U.S...

Publication/Podcast

Responsible Research During the COVID-19 Pandemic

Publication/Podcast

Two Proposed Rules Aim to Increase Organ Donation in the U.S.

Matter

Conflicts of Interest

Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.

Publication/Podcast

COVID-19 Expanded Access Template

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements...

Matter

Common Rule

Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.

News

Michael K. Fee to Lead Verrill’s Health Care and Life Sciences Defense Practice

(January 22, 2020) – Verrill is pleased to welcome Michael K. Fee to the firm’s Boston office as a Partner in its nationally recognized Health Care & Life Sciences Group and as the leader...

Matter

European Union GDPR—Institution

Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...

Publication/Podcast

COVID-19: FDA Clinical Trial Guidance

On March 18, 2020, the U.S. Food & Drug Administration (“FDA”) published guidance for clinical trial sponsors, investigators, and institutional review boards (“IRBs”) on conducting clinical trials in the midst of the COVID-19 pandemic...

Matter

Multi-Site Global Research

Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...