Upcoming and Past Events
On October 27, Dr. Kush Dhody, Senior Vice President of Clinical Operations, conducted the webinar Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design. The recording of this webinar is now available.
Cancer treatments are fulfilling the promises of personalized medicine. One aspect is the use of biomarkers detectable in blood such as circulating tumor cells. This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints; and umbrella or basket designs that allow multiple drugs to be tested against a cancer in a single trial, or a single drug to be tested against multiple cancer types in a single trial. Dr. Dhody also discusses the challenges of interpreting traditional survival analysis methods in this era of personalized cancer immunotherapies.
View the webinar recording on our YouTube channel.
(September 16, 2020) – Amarex Taiwan, LLC, an NSF International company, will exhibit and present at the 2020 Bio Innovation Conference hosted by the Maryland Technology Council and held October 5-6.
The conference anticipates participation by 300 bioscience industry leaders involved in clinical product development and business success. Speakers will share experiences and information about best practices for clinical product business start-ups. Significant participation by international companies is expected. The two-day conference will be conducted online and includes presentations, panel discussions, live Q&A, and a one-on-one partnering program.
Amarex President & CEO, Dr. Kazem Kazempour, will present at Session C: Entrepreneurship Track, ‘Business Resiliency for the Unexpected and Expected’
Business resiliency implies ability to handle unexpected, difficult situations: lack of funding, a failed clinical trial, a surprise FDA audit, loss of a key employee, a lawsuit, stagnant sales, etc.; but it also means preparedness for achieving expected goals: licensing a product, raising funds, advancing the product, selling the product or business, etc. In this session a panel of entrepreneurs will share advice on business resiliency based on their business experiences.
Register for this conference at https://www.marylandlifesciences.com/conference/.
KoNECT-MOHW-MFDS International Conference Virtual | Sep 9-11
(September 04, 2020) – Amarex Taiwan, LLC, an NSF International company, is pleased to announce exhibiting at 2020 Korea National Enterprise for Clinical Trials (KoNECT) Ministry of Health and Welfare (MOHW) Ministry of Food and Drug Safety (MFDS) International Conference Virtual, held September 09-11. This year, the conference will be live-streamed online and offers presentations and workshops on new technologies and approaches to clinical trials in Asia, with a special focus on advanced regenerative medicine, biopharmaceuticals, and medical devices.
Register for this conference (and sign up for virtual partnering with us) at https://www.konectintconference.org/.
Visit us at virtual booth #2: http://www.kic-exhibition.or.kr/contents/company02.php.
Taipei, Taiwan (August 14, 2020) – On 24 July 2020, Amarex Taiwan, LLC President & CEO, Dr. Kazem Kazempour, keynoted at BioAsia-Taiwan 2020 on Clinical Trials for Advanced Therapies.
Clinical trial design for advanced therapies differs from clinical trial design for other pharmaceutical products. Dr. Kazempour discusses the challenges at the design and analysis stages of clinical development for these products, including sample size and power calculations for efficacy. Strategies for successful design are covered and special programs, such as Expedited Programs, are suggested when applicable.
View the full recording at here.
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/.
The full recording of our complimentary webinar, reviewing clinical trial design, is available here.
This webinar is presented by Amarex President & CEO, Dr. Kazem Kazempour. He addresses 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 are discussed. This webinar focuses specifically on the advantages and disadvantages of adapting a clinical trial.
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 firstname.lastname@example.org, and Chia-hua Maggie Ho, at email@example.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:
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
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 firstname.lastname@example.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.
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:
Taipei, Taiwan (October 29, 2019) – Amarex is pleased to announce that it will participate in two fast-approaching partnership opportunities in Europe: BIO-Europe Fall 2019 and the Lunch and Learn: Health Sciences’ Industry Updates seminar hosted by NSF International, Amarex’s partner company.
BIO-Europe Fall 2019 will be held November 11-13 at the Hamburg Messe and Congress conference center in Hamburg, Germany. This conference brings together life science leaders in biotech, pharma and finance for informative networking and global collaboration with a focus on European innovation. Peter Frantz, Sr. Vice President of Business Operations for Amarex Clinical Research, LLC will join Amarex Europe and NSF International team members to participate in this BIO partnering conference. Amarex will showcase services alongside NSF International at NSF’s booth # 65.
For additional information, or to register for this conference, visit https://ebdgroup.knect365.com.
On November 13, from 11:00 AM – 3:00 PM, NSF International will host the Lunch and Learn: Health Sciences’ Industry Updates seminar at NSF Prosystem’s offices in Hamburg. This free seminar will present recent regulatory changes within the healthcare sector and offers unique networking opportunities for experts and participants. Attendees will also receive participation certification. Dr. Kazem Kazempour, President & CEO of Amarex, will present at this seminar on the topic of US FDA Regulatory and Clinical Strategies for Successful Companion Diagnostics Development.
For additional information, or to register for this seminar, view the flyer or contact Juliane Celik at email@example.com.
Amarex Clinical Research, LLC is pleased to announce that Amarex Taiwan’s COO, Dr. Chia-Hua Maggie Ho, will keynote at the 2019 Taiwan Food and Drug Administration (TFDA) Seminar for Pre-marketing Regulatory Review of Smart Medical Devices in Worldwide Countries. This seminar will be held on September 25 at the National Taiwan University Hospital (NTUH) in Taipei, Taiwan. The latest medical device regulations and management measures in Taiwan, as well as the development of regulations for smart medical device in worldwide countries, will be outlined. Additionally, this seminar invites clinical and regulatory experts to share case studies and practical application expertise in the area of artificial intelligence (AI) and machine learning (ML) medical devices, in order to provide reference material for product development to related manufacturers and research teams.
On Wednesday, September 25 at 14:15 in Conference Room 402CD, International Conference Center, NTUH, COO of Amarex Taiwan, Dr. Chia-Hua Maggie Ho, will keynote on the topic of “AI/ML-based SaMD in med tech: how should it be applied and regulated?”
To view the agenda or to register for this seminar, visit
Amarex will participate in the Bio Innovation Conference to be held on 07 October 2019 at the Bethesda North Marriott Hotel and Conference Center. This conference is hosted by the Maryland Tech Council, Maryland Life Sciences (MDLS) division, and invites over 300 industry leaders to share experiences and information about developments in Cellular and Gene Therapy (CGT). It is a full day of presentations, round tables, and panel discussions by industry experts. Conference features include:
Keynote speaker John Tisdale, M.D., Chief, Cellular and Molecular Therapeutics Branch, National Heart, Lung, and Blood Institute, National Institutes of Health
One-on-One Partnering program
Fantastic Therapies, Fearsome Prices
Regulatory Reality Checks
Innovations in Biomanufacturing
Concluding networking reception
To register for this conference, please visit:
Use promotional code BICPROMO for a special discounted rate.
Amarex is pleased to announce that our President & CEO, Dr. Kazem Kazempour, is an invited speaker at the 2019 CBA Annual Conference. The 2019 Chinese Biopharmaceutical Association (CBA) Annual Conference will be held Jun 10-11, at the Baiyun International Convention Center in Guangzhou, China. This conference brings together industry leaders from the US and China in the life sciences field for unique networking opportunities. The theme of this year’s conference is: Transforming the Biopharmaceutical and Healthcare Industry through Cutting Edge Technologies and Global Cooperation.
Members from Amarex Taiwan will also be in attendance at this conference, as Amarex Clinical Research (US) and Amarex Taiwan work together to support Chinese-US collaboration, with a focus on bringing Chinese products to the US Market. Dr. Kazempour will present on Monday, June 10 at 15:45 in Oriental Hall, on the topic of Challenges and Opportunities in Trial Design and Analyses of China/USA Dual Submission.
To view the agenda or to register for the 2019 CBA Annual Conference, visit https://cba-usa.org/content/2019-cba-annual-conference.
Amarex is pleased to announce that our President & CEO, Dr. Kazem Kazempour, is an invited speaker at the 2019 Digital Medicine Summit/Matching Forum. The 2019 Digital Medicine Summit/Matching Forum will be held May 14, at National Yang-Ming University in Taipei, Taiwan. This conference will explore innovative applications of artificial intelligence (AI) in healthcare and consider new opportunities in digital medicine through interdisciplinary cooperation. The Digital Medicine Summit will host the first ever “Digital Medicine Alliance” meeting, which intends to prevent/treat diseases through the application of AI techniques.
Dr. Kazempour will keynote on Tuesday, May 14 at 15:55 on the topic of US FDA Perspective on the Latest Challenges and Opportunities to Regulate AI/ML-Based health Products. Members from Amarex Taiwan will also be in attendance at this conference.
Please click here to view the presentation video of Dr. Kazempour at Digital Medicine Summit in National Yang-Ming University (NYMU) on May 14th.
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.
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/.
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
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.
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 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.
Amarex is pleased to announce its role as a presenting sponsor at BioTaiwan 2018, held July 18-22 at TWTC Nangang Exhibition Hall in Taipei, Taiwan. With biotechnology booming in Taiwan, and with the opening of Amarex Taiwan earlier this year, this conference offers growth opportunities for Amarex as a member of the global life sciences community.
On Wednesday, July 18 at 16:30 in Ballroom B, President & CEO of Amarex, Dr. Kazem Kazempour, will keynote on the topic of FDA Clinical and Regulatory Trends on Accelerating Approval of Biological Products. The presentation will examine the latest strategies for FDA approval, discuss the application of FDA guidelines to accelerate research development, and offer a number of enrichment strategies and adaptive trial designs that lead to successful outcomes for clinical trials.
Amarex has provided steady growth of services to Taiwanese organizations for the past ten years, and has worked to build a strong international client base for the past 15 years, notably in Asia, to help bring non-US products to the US market. Amarex has a unique understanding of the challenges related to global clinical product development.
Dr. Kazem Kazempour, President & CEO of Amarex Clinical Research, will present on the topic of US FDA Novel Regulatory Strategies for Accelerated Approval: Acceptance of Clinical Trial Data from Asia, at BIO KOREA 2018, held May 9-11 at Starfield COEX Mall in Seoul, South Korea.
Over the last 15 years, Dr. Kazempour has focused on building a strong international client base, with notable development in Asia, to help bring non-US products to the US market. The newly formed affiliate organization, Amarex Taiwan, LLC, was established to offer greater breadth and depth of services to Amarex’s Taiwanese client base. With experience working both at the FDA and with the FDA (representing Amarex’s clients), Dr. Kazempour has unparalleled expertise developing advantageous FDA approval strategies for both US and non-US clients. In this presentation, Dr. Kazempour will discuss the necessity of international collaboration, key elements that expedite FDA market approval and customized strategies for a successful FDA defense. Dr. Kazempour will present on Wednesday, May 09 at 13:00 in Room 301A.
Amarex staff members will also be present at the BIO KOREA 2018 exhibit hall booth #F47
Focusing on the most pressing challenges and opportunities to bring rare disease therapies to patients faster.
Amarex Clinical Research will exhibit at World Orphan Drug Congress USA 2018 and Dr. Kazem Kazempour, President and CEO of Amarex, will keynote on the topic of Orphan Drug Development: Using Outside Data for Marketing with the US FDA.
With a focus on European innovation and global collaboration, BIO-Europe Spring is the premier springtime partnering conference bringing together a “whoʼs who” from biotech, pharma and finance in the most innovative biopharma clusters in Europe for high-level networking, pre-scheduled partnering meetings, strategic panel discussions and more.
This event is expected to draw over 3,800 industry attendees for three days of high level networking, representing upwards of 2,000 companies from over 60 countries.
Partnering as an overall business strategy has transformed drug development in bringing together innovators and visionaries with seasoned experts from every corner of the globe.
BIO-Europe is the preeminent partnering conference for the life sciences, bringing together international decision makers from the biotechnology, pharmaceutical and financial sectors, offering networking opportunities, workshop and panel participation, a high profile exhibition, and private, prescheduled one-to-one meetings.
The nation’s largest and most well-respected interdisciplinary wound care program within the clinical field.
The Symposium on Advanced Wound Care (SAWC) is committed to providing the highest level of clinical education and information for physicians, nurses, physical therapists, researchers, podiatrists and dietitians involved in wound healing or wound care issues.
Amarex Clinical Research will be attending this conference, come meet us at Booth 138.
Amarex Clinical Research will host a seminar on optimizing clinical development for US FDA market approval. Key note speakers include the following Amarex team members: Dr. Kazem Kazempour, President & CEO, and Dr. Olga Pavlova, Regulatory Manager for the Department of Regulatory Affairs. Topics of discussion will include new FDA botanical drug guidance, 505(b)(2) vs ANDA and Biobetter vs Biosimilar, and accelerated product development.
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