最新消息 | 活動

Amarex Senior Vice President of Safety and Pharmacovigilance, Shide Badri, MD, is conducting a free webinar on Tuesday, April 7, 2020 at 11:00 AM EDT entitled Upgrading the FDA Adverse Event Report System (FAERS) Based on International Council for Harmonisation (ICH) E2B (R3) Standards.

This webinar addresses the US FDA’s plan to modernize electronic submission standards for drug, biological and drug/biologic-led combination products for the premarket and post market safety surveillance programs. The webinar summarizes upgrades to electronic submission of Individual Case Safety Reports (ICRs) in the FDA Adverse Event Reporting System (FAERS) using ICH E2B(R3) standards that are disclosed to the public, FAERSII’s implementation timeline, benefits and impacts on stakeholders and industry.

For more information or to register for this webinar, visit:

http://www.nsf.org/training-education/training-entry/webinar-upgrading-the-fda-adverse-event-reporting-system-faers

From March 23-25, in Paris, France, Amarex President & CEO, Dr. Kazem Kazempour, and Senior Vice President of Business Operations, Peter Frantz, will team up with Amarex Europe staff at BIO-Europe Spring. Amarex is currently conducting clinical trials in several European countries for clients located around the world. Amarex is also working with EU clients to bring their products to the US market. BIO-Europe is a distinct conference bringing together leaders in biotech, pharma and finance for informative networking and development relevant to European innovation and global collaboration.

On March 23rd at 5:00 PM, following Monday’s conference activities and next door to the BIO-Europe Spring Congress, at the Mercure Hotel Vaugirard Porte de Versailles, Amarex will host a Cocktail & Learn on the topic of IND/IDE Submissions and Acceptance of Foreign Clinical Data by the US FDA. This workshop will be presented by Dr. Kazempour and is free of cost.

Register for BIO-Europe at https://ebdgroup.knect365.com/bioeurope-spring/

Register for the Amarex hosted workshop at

https://docs.google.com/forms/d/e/1FAIpQLScLDQxmGtubAFaunarMXQ4k9rRyfXHXQBamkPlDcIsgedqp2w/viewform

On 29 November 2019, at the Global Research & Industry Alliance of National Cheng-Kung University (GLORIA NCKU) in Tainan City, Taiwan, Dr. Kazem Kazempour, President & CEO of Amarex, keynoted on the topic of Current Regulatory Thinking on AI/ML as SaMDs. In addition, Dr. Chia-Hua Maggie Ho keynoted on the topic of Software as a Medical Device (SaMD): Verification, Validation and Clinical Evaluation and on the topic of AI and Machine Learning as Medical Device, Premarket Application to US FDA.

To view these presentations, visit:

https://www.youtube.com/channel/UCqqBV5BlRdXaEfGOqjb6ZDA.

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媒體 | 新聞發布

Mar 29, 2020

On March 27, Amarex executed a rush submission to the US FDA of an Emergency Use Authorization (EAU) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea and Amarex and its client are therefore hopeful for a rapid FDA approval result.

Mar 19, 2020

In the past week Amarex worked with client CytoDyn to prepare, submit and achieve FDA approval for an EUA for CytoDyn’s leronlimab, a monoclonal antibody product, as a potential treatment for coronavirus disease 2019 (COVID-19). Amarex CEO, Dr. Kazem Kazempour, explained, “Cytodyn’s product has the potential to control the body’s hyper-immune response to coronavirus infection which contributes to life threatening side-effects of the disease.”

Feb 10, 2020

Amarex Taiwan, LLC announces that the Taiwan Food and Drug Administration (TFDA) approved an IND application for an Amarex client to proceed with their Phase I/IIa study of a new chemical entity (NCE) in the treatment of patients with pancreatic cancer. Pancreatic cancer is a deadly cancer with a high unmet medical need and preliminary nonclinical data shows potential efficacy and safety of the new chemical entity in the treatment of pancreatic cancer.

Jan 27, 2020

2019 was an exciting year of growth and discovery for Amarex Clinical Research and Amarex Taiwan, and we are excited to report the below noteworthy achievements.

Jan 23, 2020

Amarex Clinical Research, LLC is pleased to announce that a white paper authored by Hana Mekonnen, MS, Senior Vice President of Biometrics for Amarex, was published in the NSF Health Sciences Journal, Issue 46.

The full journal is available here, and at NSF.org.

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