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The term software as medical device (SaMD) can be broadly defined as software that is intended to be used for one or more medical purposes without being part of a hardware medical device. SaMD products vary greatly in terms of uses and complexity, and include everything from image-reading software that runs on a smartphone to advanced artificial intelligence (AI) such as machine learning algorithms. This workshop will introduce regulatory strategy and clinical evaluation required for the marketing approval of software and AI-related medical products. It includes the current international medical software regulation and risk management of AI medical products, and what is software as medical device, and introduces the recent FDA regulation trends. Furthermore, there will be case study of the medical product development for receiving marketing approval by US FDA.
Organizer: PITDC, Taiwan
Co-organizer: Amarex Taiwan, LLC.
Date: 1:00 p.m. to 5:00 p.m., Monday, 13th May 2019
Venue: NKSP Convention Center (Building A, Nan-Kang Software Park)
Address: 2F, No.19-10, Sanchong Road, Taipei 115, Taiwan, R.O.C.
Participants: AI Medical Industry, ICT industry, R&D, RA, etc.
Language: English
Certification: 3 hours continuous education certificate (e-form)
Register Fee: TWD $1,200/person (Early bird: TWD $1,000/person if paid before 3rd May 2019)
Registration: Please visit https://forms.gle/EasphT8SVFyDEpP77
Peter Frantz, Sr. Vice President of Business Operations for Amarex Clinical Research, will visit Vienna, Austria from March 25-27, and join Amarex Europe team members to participate in the BIO partnering conference. Relevant to European innovation and global collaboration, BIO-Europe Spring is a distinct conference that brings together leaders in biotech, pharma, and finance for informative networking and development.
This conference will provide Amarex with an opportunity to strengthen its engagement in Europe as well as globally, while meeting with current and potential clients. At present, Amarex is 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.
Register for this conference at https://ebdgroup.knect365.com/bioeurope-spring/.
Early November Conference Activities and Networking Opportunities
In early November, Amarex will participate in the following industry conferences: The 4th Annual Korea – US Cooperative Conference for Life Sciences (KUCCLS 2018), The Symposium on Advanced Wound Care (SAWC Fall 2018) and BIO-Europe Fall 2018.
KUCCLS 2018 will be held November 1-3 at the Institute of Bioscience and Biotechnology Research in Rockville, Maryland. This conference supports US-Korea collaboration in biotechnology through the exchange of information and ideas across many life science disciplines, including healthcare, academia and government research institutions. Amarex maintains considerable interest in US-Asia biotechnology development and will be present at KUCCLS 2018 as a corporate sponsor. Registration is available at www.kuccls.org.
SAWC Fall 2018 will be held November 2-4 at Caesars Palace in Las Vegas, Nevada. This conference connects researchers, scientists and healthcare professionals within the field of wound care to improve clinical outcomes through education. Amarex will showcase services at SAWC Fall in the Octavius Ballroom, booth #138. For additional information, visit http://www.sawc.net/fall/.
BIO-Europe Fall 2018 will be held November 5-7 at Bella Center Copenhagen in Denmark. BIO-Europe is the largest life sciences conference in Europe and offers unique opportunities for global networking in biotechnology. Team members from Amarex US and its affiliate organization, Amarex Europe, will participate in this partnering event. For registration information and/or to prearrange a one-to-one meeting with Amarex representatives, visit
Webinar: Electronic Submissions to the FDA – eCTD Requirements
Join us for our upcoming webinar:
Electronic Submissions to the FDA – eCTD Requirements
Instructor: Olga Pavlova, PhD, Regulatory Manager
Date: Thursday, 27 September, 2018
Time: 1:00PM EDT
Register at https://www.complianceonline.com/electronic-submissions-to-the-fda-ectd-requirements-webinar-training-705819-prdw.
Bio+Tech18 (Science on the Bay)
As a Maryland Tech Council Committee Member, Amarex will exhibit at the Bio+Tech18 Conference on Thursday, September 20, at the Hilton Baltimore Inner Harbor Hotel in Baltimore, MD. This conference brings together the life science and technology sectors for informative networking and statewide industry development. Conference topics cover the business of development and commercialization for medical and computer technology products.
Amarex supports the Maryland Tech Council in its objective to build a leading science and technology economy in Maryland. Amarex provides regulatory and clinical trial services to a number of Maryland life science companies, as well as to the NIH. Amarex has collaborated with Montgomery College’s Workforce Development & Continuing Education department to provide the introductory course “Clinical Trial Project Management”, and has engaged in several partnership activities with the Montgomery County Economic Development Corporation to accelerate business growth in Montgomery County, MD.
Visit us at the Bio+Tech18 Conference exhibit hall in the Key Ballroom 7-12, booth #21 to learn about our services for achieving FDA approval of medical products: drugs, devices and diagnostics.
Discounted registration fee of $149 provided by the Maryland Tech Council, with promotion code BT18PROMO. Register at http://bio-techconference.com/.
Amarex in Asia: Supporting Taiwan Biotechnology
Amarex reports continued business growth working with Taiwan’s biotech companies. Amarex’s Taiwan office provides an excellent platform for serving Taiwan and other Asian based clients. Amarex looks forward to continuing to help Asian companies bring their products to the US market.
In mid-July Amarex was a sponsor at BioTaiwan 2018. Amarex CEO, Dr. Kazem Kazempour, gave a talk on US FDA marketing approval strategies to accelerate approval of biological products.
Amarex will participate in the 2018 Medical Device Clinical Investigation Conference, Sept 5-6 at the GIS TAIPEI TECH Convention Center. MDCIC is sponsored by the Taiwan FDA and focuses on international regulatory and clinical trial design for medical device development. Dr. Kazempour will present at the conference on Thursday, Sept 6 at 14:20. His topic is “Acceptance of Foreign Clinical Data to Support Medical Device Applications and Submissions to US FDA”.
Dr. Kazempour will also make a keynote speech at The TRANS Conference 2018 in Taipei, on Sept 8 at 10:50. This is one of the largest innovative entrepreneurship symposiums for the biomedical and healthcare fields within the Asian market. His topic is “Inside FDA’s Latest Digital Health Developments”. Embracing digital health technologies, the US FDA is making its policies and processes more efficient to encourage digital health innovation. Dr. Kazempour will examine the latest regulatory paradigm from the US FDA.
To view the agenda or to register for TRANS 2018, visit https://www.transhs.asia/. For more information on the 2018 Medical Device Clinical Investigation Conference, visit http://www.pitdc.org.tw/news_detail.php?pk=37 or register for participation in the webcast at https://goo.gl/forms/4zNcay5GjAVtUlP62.