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Dr. Allison Radwick, Ph.D.

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Aug 28 noon to 1pm - CMC and Global Harmonization Discussion

Posted By Allison Radwick 08-24-2026 22:53
Found In Egroup: RegulatoryScience Community \ view thread
Join us on Friday, August 28, from 12:00 to 1:00 PM ET for a CMC and Global Harmonization Discussion. Agenda 1. Welcome and community updates - 5 minutes 2. Overview: CMC regulatory science - 10 minutes What the discipline covers and which threads are live in 2026 (Q3E, the Q1 revision, Q6(R1), nitrosamines, ...

Aug 28 noon to 1pm - CMC and Global Harmonization Discussion

Posted By Allison Radwick 08-24-2026 22:52
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
Join us on Friday, August 28, from 12:00 to 1:00 PM ET for a CMC and Global Harmonization Discussion. Agenda 1. Welcome and community updates - 5 minutes 2. Overview: CMC regulatory science - 10 minutes What the discipline covers and which threads are live in 2026 (Q3E, the Q1 revision, Q6(R1), nitrosamines, ...

FDA's ASCA Program + Networking Opportunity on August 19 in Ambler, PA

Posted By Allison Radwick 08-09-2026 07:19
Found In Egroup: RegulatoryScience Community \ view thread
Calling all regulatory professionals in the Philadelphia, New Jersey, and surrounding areas! If you're within driving distance of Ambler, PA, you are invited to join the Philadelphia and NY/NJ RAPS Chapters on Wednesday, August 19, beginning at 5:00 p.m. for an evening of networking, light refreshments, ...

Regulatory Science Community Monthly Meetings - Now on AAPS Science360

Posted By Allison Radwick 07-20-2026 13:39
Found In Egroup: RegulatoryScience Community \ view thread
A few updates on how the Regulatory Science Community is operating going forward. We are now meeting monthly on the AAPS Science 360 platform. Registration is required for each meeting. Science360 does not currently push a calendar invitation automatically, so please register and add the meeting ...

July 24 from noon to 1pm ET: AI and Digital Tools in Regulatory Practice - A Conversation with Mark Arnold and Andre Hermans

Posted By Allison Radwick 07-20-2026 12:16
Found In Egroup: RegulatoryScience Community \ view thread
Join the Regulatory Science Community | Friday, July 24, 2026 from noon to 1pm ET AI and Digital Tools for Regulatory Purposes - a conversation with @Mark Arnold and @Andre Hermans This is not a horizon-scanning talk. A working conversation about where these tools are being used now - writing, the ...

RE: Digital Twins in Biopharm - webinar is posted in AAPS Science 360

Posted By Allison Radwick 07-01-2026 14:10
Found In Library: RegulatoryScience Community

RE: Digital Twins in Biopharm - webinar is posted in AAPS Science 360

Posted By Allison Radwick 07-01-2026 14:10
Found In Egroup: RegulatoryScience Community \ view thread
Thank you to everyone who joined the Digital Twin webinar during the June Regulatory Science Community Meeting. A special thank-you to @Douglas Kiehl for an excellent presentation and a thoughtful discussion. Missed it or want to revisit? The full recording is available here: https://science360.aap ...

JUNE 26 FROM NOON TO 1PM A DIGITAL TWINS CONVERSATION WITH DOUGH KIEHL AND MONTHLY REGULATORY SCIENCE MEETINGS

Posted By Allison Radwick 06-22-2026 20:06
Found In Egroup: Pharmaceutical Quality Community \ view thread
Starting this Friday (June 26), Regulatory Science Community meetings move to AAPS Science 360. You'll sign in and register each month, and we'll post the topic and speaker as a reminder. We meet every month on the 4th Friday, 12–1 p.m. ET. This month, we're talking digital twins with @Douglas Kiehl. ...

JUNE 26 FROM NOON TO 1PM A DIGITAL TWINS CONVERSATION WITH DOUGH KIEHL AND MONTHLY REGULATORY SCIENCE MEETINGS

Posted By Allison Radwick 06-22-2026 13:51
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
Starting this Friday (June 26), Regulatory Science Community meetings move to AAPS Science 360. You'll sign in and register each month, and we'll post the topic and speaker as a reminder. We meet every month on the 4th Friday, 12–1 p.m. ET. This month, we're talking digital twins with @Douglas Kiehl. ...

JUNE 26 FROM NOON TO 1PM A DIGITAL TWINS CONVERSATION WITH DOUGH KIEHL AND MONTHLY REGULATORY SCIENCE MEETINGS

Starting this Friday (June 26), Regulatory Science Community meetings move to AAPS Science 360. You'll sign in and register each month, and we'll post the topic and speaker as a reminder. We meet every month on the 4th Friday, 12–1 p.m. ET. This month, we're talking digital twins with @Douglas Kiehl. ...

June 26 from noon to 1pm A digital twins conversation with Dough Kiehl and monthly Regulatory Science meetings

Posted By Allison Radwick 06-22-2026 13:00
Found In Egroup: RegulatoryScience Community \ view thread
Starting this Friday (June 26), Regulatory Science Community meetings move to AAPS Science 360. You'll sign in and register each month, and we'll post the topic and speaker as a reminder. We meet every month on the 4th Friday from 12–1 p.m. ET. This month, we're talking digital twins with @Douglas Kiehl. ...

USP Opens Four Draft Biologics Method Standards for Early Comment

Posted By Allison Radwick 06-12-2026 09:42
Found In Egroup: RegulatoryScience Community \ view thread
USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process. This pre-official window is a meaningful opportunity to help shape these methods before they advance toward becoming official standards. ...

USP Opens Four Draft Biologics Method Standards for Early Comment

Posted By Allison Radwick 06-12-2026 09:39
Found In Egroup: Pharmaceutical Quality Community \ view thread
USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process. This pre-official window is a meaningful opportunity to help shape these methods before they advance toward becoming official standards. ...

USP Opens Four Draft Biologics Method Standards for Early Comment

Posted By Allison Radwick 06-12-2026 09:35
Found In Egroup: Global Health (GH) Community \ view thread
USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process. This pre-official window is a meaningful opportunity to help shape these methods before they advance toward becoming official standards. ...

USP Opens Four Draft Biologics Method Standards for Early Comment

USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process. This pre-official window is a meaningful opportunity to help shape these methods before they advance toward becoming official standards. ...

USP Opens Four Draft Biologics Method Standards for Early Comment

Posted By Allison Radwick 06-12-2026 09:33
Found In Egroup: Discovery and Preclinical Research Community \ view thread
USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process. This pre-official window is a meaningful opportunity to help shape these methods before they advance toward becoming official standards. ...

USP Opens Four Draft Biologics Method Standards for Early Comment

Posted By Allison Radwick 06-12-2026 09:32
Found In Egroup: Chemistry, Manufacturing and Controls Community \ view thread
USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process. This pre-official window is a meaningful opportunity to help shape these methods before they advance toward becoming official standards. ...

Do you follow regulatory guidance outside the US? Help build our global regulations, harmonization and submission focus area

Posted By Allison Radwick 06-03-2026 10:22
Found In Egroup: Global Health (GH) Community \ view thread
Hello everyone, One of the Regulatory Science Community's focus areas is Global Harmonization & Submission Strategy, and we're partnering with the Global Health Community to build it out. We're looking for people who: • Follow regulatory guidance outside the US (Canada, Japan, China, EU, India, or ...

Do you follow regulatory guidance outside the US? Help build our global regulations, harmonization and submission focus area

Posted By Allison Radwick 06-03-2026 10:16
Found In Egroup: RegulatoryScience Community \ view thread
Hello everyone, One of the Regulatory Science Community's focus areas is Global Harmonization & Submission Strategy, and we're partnering with the Global Health Community to build it out. We're looking for people who: • Follow regulatory guidance outside the US (Canada, Japan, China, EU, India, or ...

Regulatory Science Updates and Scientific Areas of Focus

Posted By Allison Radwick 06-02-2026 18:51
Found In Egroup: RegulatoryScience Community \ view thread
Hi everyone, We had a very productive 30-minute discussion at tend of May on the question: "Where should the Regulatory Sciences Community focus its energy?" Thank you for the great responses before, during, and after the meeting! Here's a quick update on where we're headed. We've organized our work ...