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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:20250616
DTEND;VALUE=DATE:20250617
DTSTAMP:20260423T151203
CREATED:20250212T233551Z
LAST-MODIFIED:20250212T233551Z
UID:3070-1750032000-1750118399@asapprocess.co
SUMMARY:DIA Global Annual Meeting 2025 Presentation:  Advancing Premarket Safety Analytics Through FDA and Industry Partnerships
DESCRIPTION:Greg Ball\, PhD\, will present in the DIA’s Clinical Safety and Pharmacovigilance Track on Advancing Premarket Safety Analytics Through FDA and Industry Partnerships.  “We will leverage the PHUSE Safety Analytics Education library and the recent AE Groupings in Safety (AEGiS) white paper to operationalize the FDA Medical Queries and Standard Safety Tables and Figures (ST&Fs).” – Greg Ball.
URL:https://asapprocess.co/event/dia-global-annual-meeting-2025-presentation-advancing-premarket-safety-analytics-through-fda-and-industry-partnerships/
ATTACH;FMTTYPE=image/jpeg:https://asapprocess.co/wp-content/uploads/2025/02/DIA-logo.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250408
DTEND;VALUE=DATE:20250410
DTSTAMP:20260423T151203
CREATED:20250212T232454Z
LAST-MODIFIED:20250212T232454Z
UID:3068-1744070400-1744243199@asapprocess.co
SUMMARY:2nd Annual PharmaDS Conference
DESCRIPTION:PharmaDS is a unique event of industry data science leaders presenting case studies of the application of AI\, large language models\, and advanced analytics to pharmaceutical operations.  Use cases provided in functional areas such as:  regulatory\, clinical\, pharmacovigilance\, manufacturing\, and marketing & commercialization.  ASAP Process Consulting will attend to hear the cutting edge of AI in pharma.
URL:https://asapprocess.co/event/2nd-annual-pharmads-conference/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2025/02/PharmaDS-Flyer-2025.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250317
DTEND;VALUE=DATE:20250320
DTSTAMP:20260423T151203
CREATED:20250103T213652Z
LAST-MODIFIED:20250103T213749Z
UID:3041-1742169600-1742428799@asapprocess.co
SUMMARY:DIA Europe Annual Meeting 2025
DESCRIPTION:Greg will present\, along with colleagues from Roche and Bristol Myers Squibb\, to the Safety and Pharmacovigilance Track of the Drug Information Association’s Annual European Meeting on: Regaining Global Alignment on Safety Reporting from Clinical Trials.
URL:https://asapprocess.co/event/dia-europe-annual-meeting-2025/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2025/01/DIA-Europe.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250130
DTEND;VALUE=DATE:20250131
DTSTAMP:20260423T151203
CREATED:20250129T165242Z
LAST-MODIFIED:20250212T233622Z
UID:3049-1738195200-1738281599@asapprocess.co
SUMMARY:CITI Program- Free Industry Resource
DESCRIPTION:CITI Program in collaboration with ASAP Process Consulting\, Inc. has created a training resource that is free for industry\, in the spirit of advocating for FDA’s IND Safety Final Rule (2010).  Greg Ball\, PhD\, presents a detailed introduction to the Aggregate Safety Assessment Planning process and IND Safety Reporting for any industry professional\, patient\, or caregiver seeking to learn more about ongoing advancements in drug safety.
URL:https://asapprocess.co/event/citi-program-free-industry-resource/
LOCATION:CITI Program\, United States
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2025/01/Untitled-design-15.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250126
DTEND;VALUE=DATE:20250127
DTSTAMP:20260423T151203
CREATED:20241210T164408Z
LAST-MODIFIED:20241210T170235Z
UID:2999-1737849600-1737935999@asapprocess.co
SUMMARY:DIA Global Pharmacovigilance and Risk Management Strategies Conference Short Course:  Aggregate Safety Assessment Planning (ASAP) Process
DESCRIPTION:Taught by Greg Ball PhD\, Safety Scientist\, and Barbara Hendrickson MD\, Safety Physician\, this session will describe how the ASAP supports multidisciplinary safety planning\, ongoing aggregate safety evaluation\, IND safety reporting decisions\, and evaluation of product level safety data and the Safety Topics of Interest\, which have the potential to influence a product’s benefit: risk assessment. An Aggregate Safety Assessment Planning (ASAP) process is critical to ensure appropriate collection and assessment of product level data and to answer key safety questions from various stakeholders. In addition\, the ASAP process strengthens safety signal detection as well as risk identification and management. The American Statistical Association Biopharma Safety Scientific Working Group has proposed an ASAP template to guide sponsor teams in clinical development.
URL:https://asapprocess.co/event/dia-global-pharmacovigilance-and-risk-management-strategies-conference-short-course-aggregate-safety-assessment-planning-asap-process/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/25002-generic-600x300-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250121
DTEND;VALUE=DATE:20250122
DTSTAMP:20260423T151203
CREATED:20250129T172057Z
LAST-MODIFIED:20250129T172328Z
UID:3053-1737417600-1737503999@asapprocess.co
SUMMARY:Continuous safety information of RCT with blinded treatment information:  Presentation to the ASA Biopharmaceutical Section Safety Working Group\, Q1 2025
DESCRIPTION:Greg Ball\, PhD\, of ASAP Process Consulting joins Patrick Schnell\, Executive Medical Director and Global Product Safety Lead at BeiGene\, to present “Continuous safety information of RCT with blinded treatment information” to the quarterly meeting of ASA’s Biopharmaceutical Section\, on January 21\, 2025.  Greg and Patrick are joined from other industry key opinion leaders from Novartis\, Merck\, AbbVie\, UCB\, Boehringer Ingelheim\, and Moderna to discuss other important developments in the field of quantitative methods and tools for safety monitoring in clinical trials: \n\nSafety Signal Exploration using BDRIBS (Merck\, AbbVie)\nA Bayesian method for safety signal detection in ongoing blinded randomized controlled trials (UCB)\nAn open-source modular approach to Safety Visualization and Analysis (Boehringer Ingelheim)\nMeta-analysis of blinded and unblinded studies (Moderna)\nQuantitative Safety Monitoring in Clinical Trials for infrequent events (Novartis)
URL:https://asapprocess.co/event/continuous-safety-information-of-rct-with-blinded-treatment-information-presentation-to-the-asa-biopharmaceutical-section-safety-working-group-q1-2025/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2025/01/ASA-Safety-Working-Group-Quarterly-Scien�fic-Webinar-–-Q1-2025.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20241214T080000
DTEND;TZID=UTC:20241214T170000
DTSTAMP:20260423T151203
CREATED:20241214T155807Z
LAST-MODIFIED:20241214T155809Z
UID:3029-1734163200-1734195600@asapprocess.co
SUMMARY:The Effective Statistician Podcast:  What is the ASAP and What You Should Know About It
DESCRIPTION:Greg joins industry thought leader Dr. Alexander Schacht of The Effective Statistician on Alexander’s podcast to discuss the Aggregate Safety Assessment Planning process. \nAre you curious about aggregate safety assessment planning? \nWhether you’re an experienced statistician or just starting out in the field\, your work increasingly demands that you apply principles of aggregate safety assessment planning. With an ever-changing and advancing landscape filled with data and technology advancements\, it is essential to stay current on this topic. \nIn episode\, Greg and I explore what aggregate safety assessment planning is\, its components\, its importance for statistically informed decisions\, and how it ties into patient safety initiatives. \nYou will be equipped with a better understanding of the fundamentals so that your efforts can make powerful contributions in research settings and support meaningful health outcomes for patients everywhere.
URL:https://asapprocess.co/event/the-effective-statistician-podcast-what-is-the-asap-and-what-you-should-know-about-it/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/effective-stat.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20240619
DTEND;VALUE=DATE:20240620
DTSTAMP:20260423T151203
CREATED:20241213T184342Z
LAST-MODIFIED:20241213T184342Z
UID:3022-1718755200-1718841599@asapprocess.co
SUMMARY:A Safety Surveillance Plan (SSP) for Serious Anticipated Events
DESCRIPTION:A number of questions remain about Safety Surveillance Plans (SSPs). This session\, Chaired by Greg Ball of ASAP Process Consulting\, presents experiences from  multiple sponsors who have developed processes to address the FDA’s recommendations in the 2021 guidance.  Topics such as:  identifying when a safety surveillance plan (SSP) is warranted; specifics on implementation of the trigger method; how to evaluate a product in different patient populations and ensure study integrity;  clarification of roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting\, and more.
URL:https://asapprocess.co/event/a-safety-surveillance-plan-ssp-for-serious-anticipated-events/
ATTACH;FMTTYPE=image/jpeg:https://asapprocess.co/wp-content/uploads/2024/12/DIA-2024.jpeg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20240603
DTEND;VALUE=DATE:20240606
DTSTAMP:20260423T151203
CREATED:20241213T183559Z
LAST-MODIFIED:20241213T190434Z
UID:3019-1717372800-1717631999@asapprocess.co
SUMMARY:FDA/PHUSE Computational Science Symposium
DESCRIPTION:Greg Ball represented PHUSE’s Safety Analytics Working Group at the PHUSE/FDA Computational Science Symposium (CSS) 2024\, along with Scott Proestel\, Sr. Medical Officer\, FDA\, and Mary Nilsson\, Statistician\, Eli Lilly.  CSS brought together a community of 212 passionate individuals. who gained access to direct insights into regulatory topics from health authorities and explored a range of ideas crucial to the future of computational science. The CSS stands as a testament to the industry’s commitment to advancing drug development and regulatory science through both collective effort and data-driven decision-making.  Meeting summary link below.
URL:https://asapprocess.co/event/3019/
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END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20240507
DTEND;VALUE=DATE:20240508
DTSTAMP:20260423T151203
CREATED:20241213T191347Z
LAST-MODIFIED:20241213T191347Z
UID:3026-1715040000-1715126399@asapprocess.co
SUMMARY:Clinical Research Management Network Lecture
DESCRIPTION:Lecture to the Clinical Research Management Network Webinar-Interdisciplinary Safety Evaluation for Learning and Decision Making\, Greg Ball\, PhD\, ASAP Process Consulting.
URL:https://asapprocess.co/event/clinical-research-management-network-lecture/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/Add-a-heading-7.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20231116
DTEND;VALUE=DATE:20231117
DTSTAMP:20260423T151203
CREATED:20241211T152422Z
LAST-MODIFIED:20241211T152422Z
UID:3016-1700092800-1700179199@asapprocess.co
SUMMARY:Interdisciplinary Safety Evaluation for Learning and Decision-Making: Education for Executives
DESCRIPTION:Part 5 and final presentation in the Safety Analytics Working Group webinar series\, Interdisciplinary Safety Evaluation for Learning and Decision Making\, a collaboration of industry leaders and PHUSE\, ASA Biopharm\, and DIA\, Greg provides a succinct summary of the webinar series directed at busy executives.  Greg is joined by Jacqueline Corrigan-Curay\, Director\, Office of Medical Policy\, FDA\, Barbara Hendrickson\, Safety Physician\, Proactive Drug Safety Consulting\, LLC\,  and Sheila Mahoney-Jewels\, Drug Development Cross-Functionalist and Founder of LifeSciHub\, LLC to succinctly address how the ideas presented impact the pharmaceutical company’s “bottom line”. \n 
URL:https://asapprocess.co/event/interdisciplinary-safety-evaluation-for-learning-and-decision-making-education-for-executives/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/Add-a-heading-5.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20231018
DTEND;VALUE=DATE:20231019
DTSTAMP:20260423T151203
CREATED:20241214T165536Z
LAST-MODIFIED:20241214T165536Z
UID:3035-1697587200-1697673599@asapprocess.co
SUMMARY:AE Groupings in Safety (AEGiS): Operationalizing the FDA Medical Queries (FMQs)
DESCRIPTION:Greg joins Linda Jeng\, MD\, Associate Director for Biomedical Informatics\, FDA\, Robert (Mac) Gordon\, Sr. Statistician\, J&N and Peg Fletcher\, MD\, Safety Physician and President of MedAssessment\, Inc. for a panel discussion on how to operationalize FDA Medical Queries (FMQs) a the World Drug Safety Congress Americas meeting\, 2023.
URL:https://asapprocess.co/event/ae-groupings-in-safety-aegis-operationalizing-the-fda-medical-queries-fmqs/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/Add-a-heading-8.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20231013
DTEND;VALUE=DATE:20231014
DTSTAMP:20260423T151203
CREATED:20241214T160736Z
LAST-MODIFIED:20241214T160736Z
UID:3032-1697155200-1697241599@asapprocess.co
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/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/sdp.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20231004
DTEND;VALUE=DATE:20231005
DTSTAMP:20260423T151203
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:20260423T151203
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/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/Add-a-heading-3.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230713
DTEND;VALUE=DATE:20230714
DTSTAMP:20260423T151203
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/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/Add-a-heading-2.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230629
DTEND;VALUE=DATE:20230630
DTSTAMP:20260423T151203
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:20260423T151203
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:20260423T151203
CREATED:20241210T013134Z
LAST-MODIFIED:20241210T013326Z
UID:2980-1687910400-1687996799@asapprocess.co
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:20260423T151203
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:20260423T151203
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/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/Add-a-heading-1.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230327
DTEND;VALUE=DATE:20230328
DTSTAMP:20260423T151203
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/
ATTACH;FMTTYPE=image/png:https://asapprocess.co/wp-content/uploads/2024/12/phs.png
END:VEVENT
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