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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/.

Sign up for an NSF International medical device course and learn from experts at your own pace. Course offerings are available in auditing, premarket regulatory, quality system regulation and eLearning.

View the medical device training and education course offerings brochure.

To register for a course, or for more information, please visit nsfmedicaldevices.trainingfolks.com/store or contact healthsciences@nsf.org.

On February 22, 2020, Amarex President &CEO, Dr. Kazem Kazempour, will present a new course at Montgomery College, Rockville. Join us and explore key characteristics, traits and behaviors of effective leaders.

Register for this course at: http://aceitoc.montgomerycollege.edu/course/CourseView.aspx.

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