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.
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.
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
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!