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X-ORIGINAL-URL:https://asapprocess.co
X-WR-CALDESC:Events for ASAP Process Consulting
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DTSTART:20220101T000000
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20231013
DTEND;VALUE=DATE:20231014
DTSTAMP:20260423T164301
CREATED:20241214T160736Z
LAST-MODIFIED:20241214T160736Z
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SUMMARY:Society of Decision Professionals Webinar
DESCRIPTION:Greg Ball\, PhD\, presents to the Society of Decision Professionals webinar series on: Decision Framework for Assessing Safety in Clinical Development Programs
URL:https://asapprocess.co/event/society-of-decision-professionals-webinar/
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20231004
DTEND;VALUE=DATE:20231005
DTSTAMP:20260423T164301
CREATED:20241211T151537Z
LAST-MODIFIED:20241211T151537Z
UID:3013-1696377600-1696463999@asapprocess.co
SUMMARY:Overall Safety Assessment – Interactive Safety Graphics for Regulatory Decision-Making
DESCRIPTION:Jeremy Wildfire\, Sr. Director of Biostatistics\, Gilead\, Steve Mallett\, Sr. Manager of Statistics\, Veramed & Mat Soukup\,  Deputy Division Director and Office Biostatistics representative\, FDA/CDER join Greg Ball\, ASAP Process Consulting\, to discuss interactive safety graphics:  industry’s exploration and nascent use\, value comparison to traditional static graphics\, and exploration of use of interactive safety graphics in submissions and decision making.
URL:https://asapprocess.co/event/overall-safety-assessment-interactive-safety-graphics-for-regulatory-decision-making/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/Add-a-heading-4.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230914
DTEND;VALUE=DATE:20230915
DTSTAMP:20260423T164301
CREATED:20241211T150517Z
LAST-MODIFIED:20241211T150646Z
UID:3010-1694649600-1694735999@asapprocess.co
SUMMARY:Overall Safety Assessment – AE Groupings for Assessment of Safety Topics of Interest
DESCRIPTION:In this part 3 of PHUSE’s 5 part webinar series on Interdisciplinary Safety Evaluation for Learning and Decision-Making\, Greg Ball of ASAP Process Consulting joins Mac Gordon\, Director of Statistics\, Johnson & Johnson\, Peg Fletcher\, Safety Physician and CEO of MedAssessment\, and Scott Proestel\, Sr. Medical Officer\, FDA to discuss FDA Medical Queries and AE Groupings for Assessment of Safety Topics of Interest. \n 
URL:https://asapprocess.co/event/overall-safety-assessment-ae-groupings-for-assessment-of-safety-topics-of-interest/
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20230713
DTEND;VALUE=DATE:20230714
DTSTAMP:20260423T164301
CREATED:20241211T145527Z
LAST-MODIFIED:20241211T145527Z
UID:3006-1689206400-1689292799@asapprocess.co
SUMMARY:Overall Safety Assessment – Standard Safety Tables and Figures
DESCRIPTION:Greg facilitates this webinar with Y. Veronica Pei\, MD\, MEd\, MPH\, FACEP\, Lead Physician\, Biomedical Informatics and Regulatory Review Science\, FDA\, Mary Nilsson\, Statistician\, Eli Lilly\, and Jim Buchanan\, Covilance\, to explore FDA’s use of standardized tables and figures.  This webinar series was created and conducted in collaboration with PHUSE\, ASA Biopharm and the DIA.
URL:https://asapprocess.co/event/overall-safety-assessment-standard-safety-tables-and-figures/
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END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230629
DTEND;VALUE=DATE:20230630
DTSTAMP:20260423T164301
CREATED:20241210T014250Z
LAST-MODIFIED:20241210T014250Z
UID:2984-1687996800-1688083199@asapprocess.co
SUMMARY:Implementing the Program Safety Analysis Plan and Enhancing Ongoing Aggregate Review with an Interactive Open-Sourced Tool
DESCRIPTION:Greg joins Jacqueline Corrigan-Curay\, Principal Deputy Center Director\, Center for Drug Evaluation and Research (CDER)\, FDA\, and Robert (Mac) Gordon\, Director\, Biostatistics\, Johnson & Johnosn Innovative Medicines\, to present and introduce how the program safety analysis plan (PSAP) allows reviewers an effective way to perform annual aggregate safety review across a compound. Utilizing an interactive ‘real time’ application gives the ability to continuously review the safety profile. An evolution of the PSAP\, the Aggregate Safety Assessment Plan (ASAP) will be introduced and discussed.
URL:https://asapprocess.co/event/implementing-the-program-safety-analysis-plan-and-enhancing-ongoing-aggregate-review-with-an-interactive-open-sourced-tool/
ATTACH;FMTTYPE=image/jpeg:https://asapprocess.co/wp-content/uploads/2024/12/dia-boston.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230628
DTEND;VALUE=DATE:20230629
DTSTAMP:20260423T164301
CREATED:20241210T015017Z
LAST-MODIFIED:20241210T015017Z
UID:2987-1687910400-1687996799@asapprocess.co
SUMMARY:Operationalizing FDA Medical Queries
DESCRIPTION:Chaired by Greg Ball of ASAP Process Consulting and PHUSE AE Groupings in Safety (AEGiS) Project Team\, this session introduces new FDA guidance focused on enhancing safety analytics and discuss how cross-industry working groups have been preparing the ecosystem for operationalizing them: FDA Medical Queries and Standard Safety Tables and Figures.  In addition to Robert Robert (Mac) Gordon\, J&J and PHUSE Safety Analytics Working Group\, and Barbara Hendrickson\, MD\, Safety Physician and DIA-ASA Interdisciplinary Safety Evaluation (DAISE) Working Group: The Aggregate Safety Assessment Planning (ASAP) Project Team\, FDA speakers include: Scott Proestel\, MD\,  Y. Veronica Pei\, MD\, MEd\, MPH.
URL:https://asapprocess.co/event/operationalizing-fda-medical-queries-2/
ATTACH;FMTTYPE=image/jpeg:https://asapprocess.co/wp-content/uploads/2024/12/dia-boston2.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230628
DTEND;VALUE=DATE:20230629
DTSTAMP:20260423T164301
CREATED:20241210T013134Z
LAST-MODIFIED:20241210T013326Z
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SUMMARY:Clinical Safety & Pharmacovigilance Community Roundtable
DESCRIPTION:Greg Ball leads the Roundtable Discussion ‘sfor DIA Clinical Safety & Pharmacovigilance Community to follow up the session: Operationalizing FDA Medical Queries.
URL:https://asapprocess.co/event/operationalizing-fda-medical-queries/
ATTACH;FMTTYPE=image/jpeg:https://asapprocess.co/wp-content/uploads/2024/12/dia-2023.jpeg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230626
DTEND;VALUE=DATE:20230627
DTSTAMP:20260423T164301
CREATED:20241210T011705Z
LAST-MODIFIED:20241210T011705Z
UID:2975-1687737600-1687823999@asapprocess.co
SUMMARY:Artificial Intelligence:  Delivering on the Promise
DESCRIPTION:Greg Ball PhD Chairs this session at the DIA Annual Meeting to explore three real-world examples of the benefits of artificial intelligence in pharmacovigilance data handling. The examples will include triage of COVID-19 vaccine adverse events\, automated analysis of case narratives\, and results of work from the TransCelerate initiative.  Greg joins fellow speakers \nJane Carroll- Vice President\, Commercial and Medical Operations\, Moderna \nSherrine Eid- Global Head\, RWE\, Epidemiology and Observational Research\, SAS Institute Inc \nNeal Grabowski- TransCelerate IAO Workstream Lead; Head\, Signal Management\, Sanofi
URL:https://asapprocess.co/event/artificial-intelligence-delivering-on-the-promise/
ATTACH;FMTTYPE=image/jpeg:https://asapprocess.co/wp-content/uploads/2023/02/DIA-rev-1.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230615
DTEND;VALUE=DATE:20230616
DTSTAMP:20260423T164301
CREATED:20241210T020234Z
LAST-MODIFIED:20241211T143719Z
UID:2991-1686787200-1686873599@asapprocess.co
SUMMARY:Scientific Evaluation of Safety Data and Aggregate Safety Assessment Planning for IND Safety Reporting
DESCRIPTION:The PHUSE Safety Analytics Working Group welcomes Greg Ball\, ASAP Process Consulting\, Jacqueline Corrigan-Curay\, FDA\, Barbara Hendrickson\, University of Chicago & Brian Waterhouse\, Merck to discuss Scientific Evaluation of Safety Data and Aggregate Safety Assessment Planning for IND Safety Reporting\, part 1 of a 5 part Webinar Series.
URL:https://asapprocess.co/event/scientific-evaluation-of-safety-data-and-aggregate-safety-assessment-planning-for-ind-safety-reporting/
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20230327
DTEND;VALUE=DATE:20230328
DTSTAMP:20260423T164301
CREATED:20241214T174916Z
LAST-MODIFIED:20241214T174916Z
UID:3038-1679875200-1679961599@asapprocess.co
SUMMARY:PHUSE Community Forum: Reimagining a Safety Submission –  Aggregate Safety Assessment Planning
DESCRIPTION:Greg Ball\, of ASAP Process Consulting and Mary Nielson of Eli Lilly present:  Reimagining a Safety Submission – Aggregate Safety Assessment Planning.  The focus of this Community Forum was the various efforts related to interactive safety reviews. The presentation was followed by a discussion on the end goal\, potential impact on submissions\, and different models for creating and sharing interactive safety review tools.
URL:https://asapprocess.co/event/phuse-community-forum-reimagining-a-safety-submission-aggregate-safety-assessment-planning/
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