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Type: 15: Content-Hubs clear filter
Monday, June 16
 

12:10pm EDT

CH: Leading Teams Through Organizational Change and Layoffs - Best Practices for Change Management
Monday June 16, 2025 12:10pm - 12:40pm EDT
TBD
Component Type: Workshop
Level: Advanced

Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.

Learning Objectives

Identify key change management strategies to lead teams effectively through organizational change and layoffs. Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions. Develop action plans to support employees, minimize disruption, and ensure business continuity.

Chair

Vidya Narayanaswamy, MBA, MSc

Monday June 16, 2025 12:10pm - 12:40pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   07: ProjectManagement-StrategicPlanning, Workshop

12:50pm EDT

CH: Regulatory Intelligence to Drive Regulatory Strategy
Monday June 16, 2025 12:50pm - 1:20pm EDT
TBD
Component Type: Workshop
Level: Intermediate

The lifecycle of a Health Authority (HA) advice/feedback from its receipt to how it shapes and drives regulatory strategy will be uncovered with the lens of regulatory intelligence. Discuss the systems, and processes to manage HA advice/feedback

Learning Objectives

Discuss methods, techniques and best practices organizations employ to manage Health Authorities (HA) advice/feedback. Evaluate how HA advice is made searchable to gather internal regulatory precedence and how it informs regulatory strategy. Describe how to build a robust regulatory intelligence framework to manage HA advice/feedback and translate them into actionable insights.

Chair

Meena Naren Muthiah, MPH, MS, RAC

Monday June 16, 2025 12:50pm - 1:20pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Workshop |   15: Content-Hubs, Workshop

1:30pm EDT

CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
Monday June 16, 2025 1:30pm - 2:30pm EDT
TBD
Component Type: Workshop
Level: Advanced

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.

Learning Objectives

Recognize the importance of post-approval changes in a product life cycle. Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply. Propose the key requirements to take steps industry-wide to solve "A global problem needs a global solution."

Chair

Ana Sengupta, MBA, MS, RAC

Monday June 16, 2025 1:30pm - 2:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   10: RegCMC-Product Quality, Workshop
 
Tuesday, June 17
 

11:40am EDT

CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.

Learning Objectives

Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster. Discover how digital protocols are already driving connections and efficiencies at research sites. Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.

Chair

Denise Meade, MBA

Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   02: ClinTrials-Ops, Workshop

12:20pm EDT

CH: Diversity Action Plans - Listen, Learn, and Execute
Tuesday June 17, 2025 12:20pm - 12:50pm EDT
TBD
Component Type: Workshop
Level: Intermediate

The session will provide an overview of FDA Diversity Action Plans and relevant implications for industry, equipping pharma and biotech professionals with essential knowledge and pragmatic guidance for navigating the evolving regulatory landscape.

Learning Objectives

Discuss key changes in recent guidance, impact on clinical trials, and trends for FDA Diversity Action Plans; Collect essential knowledge and pragmatic guidance to navigate the evolving regulatory landscape for Diversity Action Plans

Chair

Teresa Oblak, PhD

Tuesday June 17, 2025 12:20pm - 12:50pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop

1:00pm EDT

CH: Navigating AI Regulation in Pharma - Global Trends, Compliance Challenges, and Harmonization Efforts
Tuesday June 17, 2025 1:00pm - 1:30pm EDT
TBD
Component Type: Workshop
Level: Intermediate

This session explores evolving AI policies, governance frameworks, and the path toward harmonized AI regulation to ensure safe, ethical, and effective AI adoption in pharma.

Learning Objectives

1. Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements. 2. Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions. 3. Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.

Chair

Christina Mack, PhD, MPH

Tuesday June 17, 2025 1:00pm - 1:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   03: Data-Tech, Workshop

3:00pm EDT

CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD
Component Type: Workshop

Currently some activities focus on accelerating rare diseases drug development by using tools and methods such as real-world data, Patient Centred Outcome measures integration, streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.

Learning Objectives

To identify innovative methodologies, technologies and tools for innovative therapy development; To collaborate with an innovative Rare Disease research Ecosystem and recall its funding opportunities.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop
 
Wednesday, June 18
 

12:20pm EDT

CH: Addressing Key Challenges in Global Biosimilar Development and Regulation
Wednesday June 18, 2025 12:20pm - 12:50pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Explore National Regulatory Authorities’ expectations for quality data packages for biosimilars in the context of rapidly evolving regulatory science, including advanced analytical tools and the opportunity to reduce clinical data requirements.

Learning Objectives

Examine challenges identified by National Regulatory Authorities regarding review of quality data packages for biological products. Identify trends in regulatory expectations for analytical vs. clinical data and use of advanced analytical tools in biosimilar development. Understand opportunities and challenges in the use of public standards to meet regulatory expectations for biosimilars.

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 →
Wednesday June 18, 2025 12:20pm - 12:50pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Workshop |   15: Content-Hubs, Workshop

1:00pm EDT

CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases?
Wednesday June 18, 2025 1:00pm - 1:30pm EDT
TBD
Component Type: Workshop

Using case examples, the session will be an interactive discussion to share learnings and the impact of the use of drug repurposing from different end users such as industry and academia with input from regulators, patients and HTA representatives.

Learning Objectives

To gain further insight on drug repurposing and share lessons learnt so far based on case examples. To identify what could be opportunities using repurposing for rare diseases. To share what has been done as part of the pilot on repurposing initiated by EMA at the end of 2021.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Wednesday June 18, 2025 1:00pm - 1:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop

3:00pm EDT

CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out
Wednesday June 18, 2025 3:00pm - 3:30pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Digital transformation at the C-suite level promises significant ROI but must be done purposefully. Attendees will explore strategic considerations in implementing AI with thought-provoking Q&A, cutting through the noise of the widespread AI buzz.

Learning Objectives

Evaluate perceived versus actual ROI for generative AI, balanced with lessons learned in past decades from traditional AI and automation. Define how to upskill internal teams to use AI effectively and responsibly while achieving business goals. Apply current understanding to brainstorm digital transformation avenues for teams and businesses beyond what is being done currently with AI.

Chair

Jason Casavant, JD

Speakers
avatar for Jason Casavant

Jason Casavant

Executive Director, Synterex, Inc., United States
Jason Casavant is a 25-year veteran in the industry and is the current head of medical and regulatory writing at Synterex, Inc. Over his career, he has held various positions in medical and regulatory writing, QA/QC, operations, training, and site monitoring.
Wednesday June 18, 2025 3:00pm - 3:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   03: Data-Tech, Workshop
 
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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
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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