San Francisco Chapter: IVDs and Diagnostics APAC-Regulatory Hot Topics Round-up Part I

RAC Credits
Chapter Events Chapter Events
Monday, 31 January 2022 (5:00 PM) - Monday, 31 January 2022 (6:00 PM) Pacific Time (US & Canada)

Member: $0
Nonmember: $25

This two-part interactive session will provide a review of the latest regulatory changes and topics affecting on in vitro diagnostic (IVD) manufacturers in Asia Pacific. The first Part will focus on IVDs and Diagnostics while the second part will focus on Medical Devices.

The IVD-Focused topics that will be covered include:

  • High-level introduction on the current state for major APAC regions
  • Upcoming and new regulations in APAC, including dates published, dates where they will become effective and deadlines
  • Impact of EU IVDR on APAC Regulations
    • Similarities and differences
  • Tips for product registrations during COVID-19
  • Updates in COVID-19 assay kit approvals in APAC
  • Updates in harmonization efforts in APAC

A live Q&A portion with the speaker will follow the presentation.

This event is brought to you by San Francisco Bay Area Chapters to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.


Learning Level: Advanced

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.


How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation. 

Learning Objectives

  • Develop an understanding of salient regulatory changes for APAC related to IVDs
  • Be better prepared to succeed with IVDs in these markets
  • Have an opportunity to ask questions about APAC regulations relevant to IVDs

Who Should Attend? 

Any industry representative that is either in the APAC region now or intending to pursue commercialization in the APAC region:

  • Regulatory Directors for IVD companies
  • QA and RA in the industry
  • Anyone operating or interested in APAC

Featured Speaker:

TJ Thiel

TJ Thiel is a Senior Director for PharmaLex Australia a division of PharmaLex, a global regulatory, quality and strategic advisory firm. He has worked in quality and regulatory affairs in the Australian, US and European medical device and diagnostics industries for more than 20 years. From major multinationals to small start-ups, TJ has deep experience with global regulatory approvals and registration, providing clients with planning and strategy suitable for both local and world-wide product launches.

Thank you to our Platinum Chapter Sponsors:

Event Policies

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

Registration fees for this event are nonrefundable. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received within 48 hours of the start of the event. To transfer a registration, email with the event title, name of the original registrant and the contact information for the new attendee. 


Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email  

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