INDiE Med Tech | Niki | Activity https://indiemedtech.com/members/nspanielsol-medtech-com/activity/ Activity feed for Niki. Mon, 11 May 2026 21:48:45 -0400 https://buddypress.org/?v=2.14.0 en-US 30 hourly 2 ce9fa5d3ed425a09490846a12970e157 Niki joined the group Codon Partners Career Corner https://indiemedtech.com/news-feed/p/660/ Wed, 07 Jan 2026 16:20:27 -0500 0 7f34cabe794050fc0575baee8bc2f73f Niki replied to the discussion P1/P2 Values RIsk Management in the forum Risk Management https://indiemedtech.com/groups/risk-management/forum/topic-discussion/p1-p2-values-risk-management/#post-4152 Thu, 18 Dec 2025 17:05:39 -0500 Reply to P1/P2 Values RIsk Management

Really great points, Aaron!

]]> b530c3a34c287c2d2a62fd359593c1eb Niki joined the group Quality https://indiemedtech.com/news-feed/p/614/ Thu, 18 Dec 2025 17:03:55 -0500 0 49f7943bdc401eb1cb26f5a7512f49aa Niki joined the group Regulatory https://indiemedtech.com/news-feed/p/613/ Thu, 18 Dec 2025 17:03:47 -0500 0 9ed1ce6e3ed268cdb1604203f655a395 Niki joined the group FDA https://indiemedtech.com/news-feed/p/612/ Thu, 18 Dec 2025 17:03:46 -0500 0 4daf70c6f077ac8a807bce58853abf1f Niki joined the group Consulting https://indiemedtech.com/news-feed/p/611/ Thu, 18 Dec 2025 17:03:43 -0500 0 da412da81e78054cc994942fd758aed8 Niki joined the group eQMS https://indiemedtech.com/news-feed/p/610/ Thu, 18 Dec 2025 17:03:28 -0500 0 fab83fa30f19add4c56400d5088e7c36 Niki replied to the discussion P1/P2 Values RIsk Management in the forum Risk Management https://indiemedtech.com/groups/risk-management/forum/topic-discussion/p1-p2-values-risk-management/#post-4125 Sun, 07 Dec 2025 12:51:04 -0500 Reply to P1/P2 Values RIsk Management

Great topic!

I think of Pharm as the overall probability (P1 x P2). This is the same as P value – so in the instances where you don’t see P1 and P2 separately, that’s likely the approach. So, if you mitigate P1 to near 0, pharm will be reduced to the same. But they are not equal.

In my experience, technical mitigations can lower P1 – probably…

Read more

]]> 2fa6655d99fbbedc0292b7a55ac6a7ce Niki updated their profile https://indiemedtech.com/news-feed/p/500/ Wed, 29 Oct 2025 14:23:44 -0400 0 ee3ad9a79bd6a25da6888a79c5fd09a1 Niki and Dongeun are now connected https://indiemedtech.com/news-feed/p/389/ Sat, 06 Sep 2025 01:51:08 -0400 0 67e3a18e06a1f18e5b86ea703ce69e56 Niki replied to the discussion Event Announcement for this amazing forum! in the forum IndieMedTech https://indiemedtech.com/groups/indiefeed/forum/topic-discussion/event-announcement-for-this-amazing-forum/#post-3500 Thu, 04 Sep 2025 21:05:11 -0400 Reply to Event Announcement for this amazing forum!

I can’t wait for this event!

]]> 6fc15620fa4adfb0552054aeb4992985 Niki created the group Marketing and Business Development https://indiemedtech.com/news-feed/p/358/ Thu, 04 Sep 2025 20:26:21 -0400 0 aea79ee4d4d75f2b5856dcb09ba5cf15 Niki joined the group Clinical Evidence https://indiemedtech.com/news-feed/p/356/ Thu, 04 Sep 2025 20:10:15 -0400 0 cf57c05a0b31c74d5975a292fed904d1 Niki joined the group Risk Management https://indiemedtech.com/news-feed/p/355/ Thu, 04 Sep 2025 20:10:13 -0400 0 e38a45eefc45ec75515fad431cdcc4e8 Niki and Nicholas are now connected https://indiemedtech.com/news-feed/p/347/ Wed, 03 Sep 2025 18:19:24 -0400 0 fa7cd6813358c2f0e2da8d7bc63a40cd Niki started the discussion Real-time AE Reporting in the forum IndieMedTech https://indiemedtech.com/groups/indiefeed/forum/topic-discussion/real-time-ae-reprting/ Sat, 23 Aug 2025 20:57:14 -0400 Real-time AE Reporting

I thought it was interesting that FDA will now report AEs real-time. I actually thought it was currently updated monthly, but looks like it was historically quarterly! https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data

fda.gov

FDA Begins Real-Time Reporting of Adverse Event Data

The U.S. Food and Drug Administration (FDA) today began publishing adverse event data on a daily basis, giving the public faster access to information on serious medication errors and product quality complaints for prescription drugs and therapeutic biologics.

]]> 2e0514b75eac5943012ae0cc07a38e63 Niki updated their profile https://indiemedtech.com/news-feed/p/275/ Sat, 23 Aug 2025 11:05:49 -0400 0 06aafea6740c4761357eb1708b64ac0d Niki updated their profile https://indiemedtech.com/news-feed/p/270/ Fri, 22 Aug 2025 20:23:58 -0400 0 df9e56b0ef37f37af4003bd1fda1bb67 Niki updated their profile https://indiemedtech.com/news-feed/p/262/ Fri, 22 Aug 2025 13:41:38 -0400 0 7af0c4893cc135e9b18302a174a4c19d Niki and Holly are now connected https://indiemedtech.com/news-feed/p/174/ Fri, 15 Aug 2025 00:12:33 -0400 0 5a9da35b5f4ff763d5319f2e7eb89ed4 Niki updated their profile https://indiemedtech.com/news-feed/p/171/ Wed, 13 Aug 2025 20:24:28 -0400 0