Life Sciences

Opening Remarks from the DIA Pharmacovigilance Strategies Conference

Pharmacovigilance

Today marks the beginning of the DIA Pharmacovigilance and Risk Management Strategies Conference in Washington, D.C., and the aura around the event is incredible. Industry speakers, short courses, hot topics, networking, education, and round-table discussions. All dedicated to enhancing the foundation for strong strategic planning and practical decision-making in pharmacovigilance programs.

The Perficient team is learning so much already, but the focus this morning is on Asia-Pacific or APAC reporting, especially on the requirements in China.

Life Sciences - How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

Get the Guide

Ls Event 22

Key Takeaways from the Session

  • A Suspected Unexpected Serious Adverse Reaction (SUSARs) can be submitted through E2B XML R3
  • In 2022, post-marketing reports are required to be submitted in E2B XML R3 format
    • First in English within 15 days, then within the next 25 days, the SUSAR should be reported again in Chinese (free text fields)
  • China received E2B(R3) on Jan 1, 2020
  • MAH should be prepared for testing with a China-based electronic report, to take at least three months

Ls Event 11

Connect with me

I, along with my colleague Vicky N. Green, are attending the DIA Pharmacovigilance and Risk Management Strategies Conference this week. Simply send us a meeting request or message through the new DIA Global App, if you are attending.

We look forward to meeting you!

About the Author

Kari Blaho-Owens, Ph.D., received her graduate degree in pharmacology and clinical therapeutics from LSU Medical Center in New Orleans, Louisiana, US. She was the Research Director and clinical toxicologist consultant in an inner-city Emergency Department at UT College of Medicine and has spent much of her career in the life sciences industry working for pharmaceutical and device companies, as well as CROs. She also served as the global head of PV at a major company. Kari is currently the head of PV at Perficient, where she leads a team that implements fit-for-purpose technology solutions and provides pharmacovigilance consulting. She is also a peer reviewer for the DIA.

More from this Author

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Subscribe to the Weekly Blog Digest:

Sign Up
Categories