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Type: 16: Community-Rounds clear filter
Tuesday, June 17
 

12:00pm EDT

Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD
Component Type: Session

Join the Advanced Therapies Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Carolyn Shore, PhD

Speakers
CS

Carolyn Shore

Senior Program Officer, National Academies, United States
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   16: Community-Rounds, Session

12:00pm EDT

Roundtable Discussion: Building a Regulatory Landscape to Support CMC Innovation
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD
Component Type: Session

Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Building a Regulatory Landscape to Support CMC Innovation (Monday, June 16 | 2:15pm - 3:15pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Allison Radwick, PhD, RPh

Speakers
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   10: RegCMC-Product Quality, Session

2:55pm EDT

Roundtable Discussion: Alphabet Soup - Utilization of Quality by Design and Risk Based Quality Management in Clinical Trials Data Goverernance
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
TBD
Component Type: Session

Join the Good Clinical Practices & QA - RBQM Working Group for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Terry Katz, MS

Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   16: Community-Rounds, Session

2:55pm EDT

Roundtable Discussion: International Regulatory Harmonization for Development of Medicines - A Look at How far We’ve Come and Where We Go From Here
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
TBD
Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session,

Chair

Chaitanya Koduri

Speakers
CK

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   09: Regulatory, Session
 
Wednesday, June 18
 

12:00pm EDT

Roundtable Discussion: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD
Component Type: Session

"Join the Clinical Research Community for a follow up round table discussion tied to session: Statistical Challenges and Innovations in Small-Sized Clinical Trials Using Composite Endpoint (Tuesday, June 17 | 1:45pm - 2:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Noel Ellison, MS

Speakers
NE

Noel Ellison

Director of Biostatistics, Trialwise, Inc., United States
A biostatistician and statistical programmer, Noel has more than 13 years of experience in clinical research. She has gained significant therapeutic area experience in Alzheimer’s, Cushing’s, Parkinson's, ALS, and phase 1 clinical pharmacology trials, including PK/EKG safety summary... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session |   16: Community-Rounds, Session

12:00pm EDT

Roundtable Discussion: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD
Component Type: Session

Join the Clinical Safety & Pharmacovigilance Community for a follow up round table discussion tied to session: Advancing Premarketing Safety Analytics through FDA and Industry Partnerships (Tuesday June 17 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Greg Ball, PhD

Speakers
avatar for Greg Ball

Greg Ball

Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   01: ClinSafety-PV, Session

12:00pm EDT

Roundtable Discussion: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD
Component Type: Session

Join the Project Management Community for a follow up round table discussion tied to session: Transforming the Project Management Role to Meet the Emerging Needs in Pharma - Extending Scope from R&D Focus to Launch Projects (Tuesday, June 17 | 10:30am - 11:30am EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Nancy Linda Styple

Speakers
avatar for Nancy Styple

Nancy Styple

Project Management Leader, Bayer AG, United States
Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →
Wednesday June 18, 2025 12:00pm - 1:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   07: ProjectManagement-StrategicPlanning, Session

2:55pm EDT

Roundtable Discussion: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD
Component Type: Session

Join the Project Management Community for a follow up round table discussion tied to session: Portfolio Management in Pharma - Strategies and Insights from Large, Medium and Small Pharma (Wednesday, June 18 | 1:45pm - 2:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Erin Mulrooney, MSc, PMP

Speakers
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc, United States
Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Session |   16: Community-Rounds, Session

2:55pm EDT

Roundtable Discussion: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD
Component Type: Session

Join the Advanced Therapies Community for a follow up round table discussion tied to session: Enhancing Global Access to Innovative Therapies - Regulatory Convergence, Harmonization, and Collaboration in Advanced Therapy Medicinal Products (Tuesday, June 17 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Brett Howard, JD, PhD

Speakers
avatar for Brett Howard

Brett Howard

Senior Director, US Regulatory Policy, USP, United States
Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   16: Community-Rounds, Session

2:55pm EDT

Roundtable Discussion: Towards Instantaneous Regulatory Decisions and Better Predictability
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD
Component Type: Session

Join the Digital Acceleration & Documents and Records Management Community for a follow up round table discussion tied to session: Towards Instantaneous Regulatory Decisions and Better Predictability (Tuesday, June 17 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Cary Smithson, MBA

Speakers
avatar for Cary Smithson

Cary Smithson

Managing Partner, LeapAhead Solutions, Inc., United States
Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology... Read More →
Wednesday June 18, 2025 2:55pm - 3:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   09: Regulatory, Session
 
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    00: Plenary
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    02: ClinTrials-Ops
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    10: RegCMC-Product Quality
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  • Level
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  • Keyword
    Advanced Analytics
    Artificial Intelligence (AI)
    Bioethics
    Biomarkers
    Cell and Gene Therapy
    Clinical Trial Design
    Diagnostics
    Digital Technology
    Global Perspectives
    Non-CE
    Patient Experience
    Payers
    Pediatrics
    Rare Disease
    Real-World Data (RWD) / Real-World Evidence (RWE)
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    Regulatory Reliance
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Monday, June 9
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EH
TBD
Virtual
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming