Hi all, Please see below the latest update from ClinicalTrials.gov Hot off the PRS: ClinicalTrials.gov Updates Available Two additional fields ...
Hi all, Please see below the latest update on EU CTIS published via Newsflash: Reminder: Winter clock stop All timers within the ...
Hi all, The Italian Medicines Agency (Agenzia italiana del farmaco [AIFA]) posted an update on November 21, 2024, regarding the provisions for Observatory ...
Hi all, EMA updated its website with the latest news on the ongoing survey for HMA-EMA Catalogues. The HMA-EMA Real-World Data (RWD) Catalogues ...
Do not miss these low rates and a chance to... ⭐ Gain insights into key global pharmacovigilance and risk management updates from regulatory bodies in ...
Hello All - Hold the date for the next (and final for 2024!) AdPromo WG held via Zoom (see below) on Thursday, December 12 @ 12:00-1:00 pm ET. Take note ...
Hi all, EMA has now published the recordings for the following events (links provided below): Clinical Trials Information System (CTIS): Walk-in ...
Hi all, Please see below the latest update on ClinicalTrials.gov PRS Test Environment and the Release Notes: Modernized PRS Test Update With the ...
Slides are now available from FDA Speaker Margaret Kober's 19 Nov 2024 presentation: UNDERSTANDING THE IND PROCESS Download slides via this link: ...
Hello Everyone: The recording from our session with FDA Speaker, Margaret Kober on the topic "Understanding the IND Process" (Shared Learning 19 Nov ...
Hi Melodi, Yes, it is being recorded and will be posted online in the Medical Writing community (within a few days). Best regards, ...
Hello, Will this Zoom be recorded for on-demand viewing later on? If so, where will it be stored? Kindest regards, Melodi ...
FINAL REMINDER!! Join us Tuesday, November 19, from 12:00 to 1:00 PM US ET , for a presentation about Investigational New Drug Applications (INDs) ...
Hi all, On November 19, 2024, EMA released its latest CTIS Newsflash, providing significant updates on CTIS and links to useful reference materials. ...
Hi all, EMA has published the slides from the webinar yesterday and can be found at below locations: Presentation - Clinical data publication: ...
Join us next Wednesday when we will have Michelle Wu, Cofounder & CEO of NyquistAI, as our guest speaker. Below is some information about her presentation.
Title: AI with ROI: real-life examples and framework to bring AI in Reg. Affairs (RA) to its full potential
Michelle will discuss the revolutionary impact of artificial intelligence with focus on RA and across the R&D, medical, and commercial lifecycle in the biopharma industry.This session will explore how AI is already creating outsized efficiency gains in life sciences and what the immediate and long-term future holds. It will focus on highly differentiated applications unique to the field.Discover how your organization can leverage cutting-edge AI applications to stay ahead in an increasingly competitive and complex industry landscape.
Templates of AI framework and list of AI for RA resources will be provided during the session for downloads.
Web Meeting Info:
https://teams.microsoft.com/l/meetup-join/19%3ameeting_YWM2YWQ4YjAtNWQwZC00MmFlLTg3OGYtM2NlZDBmZjZkNTJi%40thread.v2/0?context=%7b%22Tid%22%3a%22b7ca69fc-3511-4875-b513-02d11a251f43%22%2c%22Oid%22%3a%22086c2e35-abec-4de1-9b66-b44b0e0e2d1a%22%7d
Meeting ID: 252 305 502 428
Passcode: oD5CkT
Join us to hear Hans Van Bruggen from Celegence will share insights on what companies are doing to comply with EU CTR including using EMA’s CTIS portal. To join:
https://diaglobal.zoom.us/j/98760394748?pwd=cGxJVG1tbEw1VkNYQ1JIZ0pxZGZmUT09
DIA Regulatory Affairs Community:
Join us for the DIA Regulatory Policy and Intelligence meeting on March 19th at 12pm ET to hear Theresa Mullins (FDA) discuss Greater Regulatory Harmonization and Reliance Efforts.
Dial-in Instructions:
21 Dupont Circle NWSuite 300Washington, D.C. 20036
https://www.DIAglobal.org/
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