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Critical Elements of Conducting Early Phase Clinical Trials in the US for APAC Sponsors, Upcoming Webinar Hosted by Xtalks

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This webinar will address critical areas to consider when planning for the successful development and initiation of an early phase study in the US: regulatory, medical, operational and cultural.


TORONTO (PRWEB)

There is increasing interest in the Asia-Pacific (APAC) biotech industry in initiating early phase clinical trials in the US. This webinar will address critical areas to consider when planning for the successful development and initiation of an early phase study in the US: regulatory, medical, operational and cultural.

In terms of the regulatory piece, the featured speakers will discuss the Investigational New Drug (IND) Application process, including requirements and timelines. In addition, incorporation of non-US data as well as the potential to bridge studies and arms will be explored. Other key considerations include intellectual property (IP) export/import, shipping and customs, differences between medical and standard of care practices, study operations and site differences and overall regulatory timeline differences.

Because of the various differences in initiating and conducting early phase clinical trials between the APAC and US, it is important for the APAC sponsor to find the best CRO partner — one that is experienced in navigating the US clinical trials landscape, has proven expertise to support regulatory activities and understands cultural differences.

Join this webinar to gain insight into the key elements for APAC sponsors to consider when conducting early phase clinical trials in the US.

Join Victoria Allgood, PhD, Vice-President, Scientific Affairs, Oncology, Atlantic Research Group (ARG); Jane Fang, MD, MS, CEO & Founder of Polaris Strategic Partners, Inc.; and Frank Li, MD, PhD, RAC, Founder of BLA Regulatory, LLC, for the live webinar on Thursday, May 12, 2022, at 8am CST (China).

For more information, or to register for this event, visit Critical Elements of Conducting Early Phase Clinical Trials in the US for APAC Sponsors.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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