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Amarex Clinical Research, LLC, an NSF International company, is pleased to announce that Amarex Taiwan, LLC will keynote at BioAsia-Taiwan 2020 Online + Live. BioAsia-Taiwan 2020 will be held digitally on July 22-26. This conference brings together biotechnology and pharmaceutical leaders from around the globe to explore biotech developments and business opportunities with a focus on activities and companies in Asia.

On Friday, July 24, President & CEO of Amarex Taiwan, Dr. Kazem Kazempour, will keynote at Workshop 2 on the topic of Clinical Trials for Advances Therapies.

The design of clinical trials for advanced therapies often differs from the design of clinical trials for other types of pharmaceutical products. In this talk, Dr. Kazempour will focus on the challenges at the design and analysis stages of clinical development for advanced therapy products, including sample size and power calculations needed to establish efficacy. By identifying the challenges of these innovative and complicated clinical trial designs, we can offer strategies from different perspectives to overcome them. There are also multiple opportunities to take advantage of special programs at different stages of clinical development, including the utilization of Expedited Programs.

Additional presentations in this workshop will cover advanced immunotherapy, oncology trial design and regulatory considerations for evaluation of regenerative medicine products.

To view the agenda or to register for BIO Asia-Taiwan 2020, visit https://bioasiataiwan.com/.

Join us for a complimentary webinar on June 16th, entitled Points to Consider: Trial Design in General & Adaptive Trials in Particular.

This webinar will be presented by Amarex President and CEO, Dr. Kazem Kazempour. He will address aspects of before study and after study clinical trial design. Physicians focus groups, KOL thoughts, selecting endpoints, IP management and distribution, site selection and patient recruitment will be discussed. This webinar will also focus specifically on the advantages and disadvantages of adapting a clinical trial.

To accommodate our clients in the EU, the U.S. and Asia, this webinar is being offered at four different times.

Register for this webinar here.

The full recording of our complimentary webinar, reviewing insights into the Emergency Market Authorization of COVID-19 IVDs, is available on YouTube.

This webinar covers emergency authorization applications for the E.U., the U.S., Asia, Australia and the World Health Organization.

Learn from industry experts:

  • Robyn Meurant, Executive Director at NSF International. Before joining NSF, Robyn acted both as a professional officer and an advisor to the WHO and assisted with the development of the EUL for IVDs.

  • Chia-hua Maggie Ho, D. Phil., COO of Amarex Clinical Research, LLC, an NSF International Company. Dr. Ho specializes in APAC regulatory submission, clinical operations, business development and client services for the Pan-Pacific region.

View the full webinar here.

Contact our experts, Robyn Murant, at rmeurant@nsf.org, and Chia-hua Maggie Ho, at maggieh@amarextw.com, or get in touch with our Business Development team.

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.

In collaboration with NSF PROSYSTEM GmbH, Amarex is hosting two free training sessions covering key changes to effect clinical investigations when transitioning from the medical devices directive (93/42/EEC) (MDD) to the medical devices regulation (EU 2017/745) (MDR).

On Tuesday, March 17, 2020 at 10:00 AM EST Amarex President & CEO, Dr. Kazem Kazempour, and PROSYSTEM Managing Consultant, Clinical Affairs, Sandra Bugler, will present a free webinar reviewing regulatory requirements for clinical studies and clinical investigations.

To register for this webinar, visit https://www.nsf.org/training-education/training-entry/webinar-clinical-investigations-transitioning-from-mdd-to-mdr.

On Tuesday, March 31, 2020, from 9:00 AM – 5:00 PM, in Hamburg, Germany, Amarex and PROSYSTEM will host a free seminar addressing the current regulatory status and the relevant requirements for the planning, execution and completion of a clinical investigation, with a special focus on the Regulation (EU) 2017/745.

For more information or to register, visit https://www.nsf-prosystem.com/veranstaltungen/clinical-investigation-of-medical-devices/.

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