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Wednesday, June 18
 

10:30am EDT

Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Basic

Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.

Learning Objectives

Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

10:30am EDT

Leveraging AI and Structured Content Authoring Tools in Regulatory Medical Writing: A 1-Year Look
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Following up on 1-year of use with AI and structured content authoring tools. The implementation of these tools, their successes, pitfalls, and metrics. This session is planned to be a follow up to the 2024 presentation.

Learning Objectives

A comprehensive understanding of the successes achieved through one year of using AI and structured content authoring tools in regulatory medical writing processes; Explain pitfalls encountered along the way as well as the presenting relevant metrics for evaluation and future directions for improvement.

Chair

David Meats, II

Speaker

Speakers
Louise Lind Skov, PhD

Speaker
Eishita Agarwal, MSc


Speakers
DM

David Meats

Director, Regulatory Services Management, Certara
EA

Eishita Agarwal

Digital Innovation Manager, Medical Writing, GSK, India
Eishita, a Biochemistry Master’s graduate, brings 12 years of experience in pharmaceuticals, specializing in Clinical and Regulatory medical writing at GSK for 9 years. Transitioning to Digital Innovation Lead in 2021, she drives collaboration to integrate cutting-edge tech into... Read More →
avatar for Louise Lind Skov

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark
Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

10:30am EDT

Navigating the Challenges of Drug Delivery Using a Novel Device
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.

Learning Objectives

Analyze the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.

Chair

John Lockwood

Speaker

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC


Speakers
JL

John Lockwood

Sr. Director, Cencora Pharmalex, United States
John Lockwood, RAC, is the Senior Director of Medical Devices/IVDs for the Americas at Cencora PharmaLex, where he is responsible for managing and expanding Medical Device Services related to quality and regulatory. John has more than 25 years of experience in quality, regulatory... Read More →
avatar for Sarah Fairfield

Sarah Fairfield

Associate Director, RA Device and Combination Products (Digital Device and Softw, AbbVie
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

10:30am EDT

Practical Implementation of MRCTs Based on ICH E17 Guidelines
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Hear directly from the regulators and industry about the challenges and opportunities in applying the ICH E17 guidelines. Some cases based on ICH E17 guidelines will be presented in the panel. Panelists will be asked to make comments for each case regarding points to consider in planning or evaluating results (including acceptability for regulatory submission) for each case.

Learning Objectives

Explore how ICH E17 guidelines are being implemented in the conduct of multiregional clinical trials; Evaluate the limitations, gaps, and opportunities for applying the guideline globally.

Speaker

Panelist
William Wang, PhD


Speakers
avatar for William Wang

William Wang

President, Merck & Co, Inc
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

10:30am EDT

Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Lapses in quality have resulted in CLRs, impacting approvals and threatening supply. This session will discuss enhancements to oversight by sponsors/applicants and approaches to improve collaborative problem solving across organizations.

Learning Objectives

Understanding the current state of quality across organizations and trends for delays in regulatory approvals due to cGMP issues; Explain the approaches for enhancing oversight, including quality systems for early detection and correction; Improving contracts, agreements, and expectations between organizations for improved communication and collaborative problem solving.

Chair

Holly Kleinschrodt

Speaker
Patrick Saunders

Speaker
Rosemary Orciari

Speaker
Patrick Saunders


Speakers
HK

Holly Kleinschrodt

Head, Device Quality, Astellas, United States
Holly Kleinschrodt has over 20 years of experience in the medical device and pharmaceutical industry. Her experiences have included Quality Assurance, Manufacturing, and R&D. She has contributed to technologies such as implantable heart valves and rings, consumable infusion sets and... Read More →
RO

Rosemary Orciari

Senior Directory, Reg Intel, Policy and QMS Lead, Pfizer, United States
PS

Patrick Saunders

Senior Director, Quality, Lilly del Caribe, Eli Lilly & Co., United States
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

10:30am EDT

Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Basic

This interactive workshop designed by a behavioral scientist from Tufts CSDD will provide an experiential learning experience covering levers that can enhance leadership effectiveness using an inclusive leader framework.

Learning Objectives

Identify specific inclusive leadership behaviors that can enhance individual and team-level outcomes; Learn about the challenges and barriers associated with inclusive leadership practices; Discuss evidence-based ways to practice inclusive leadership that resonate with all employees.

Chair

Jennifer Kim, PhD

Speaker

What's Next for Developing Inclusive Leaders? 
Christine Mayer-Nicolai, PharmD

Challenges of Leading Inclusively in Cross-Functional, Mixed Teams
Tamei Elliott, MS


Speakers
avatar for Jennifer Kim

Jennifer Kim

Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Assistant Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining how diversity, equity and inclusion dynamics impact individual, group, and organizational outcomes... Read More →
avatar for Christine Mayer-Nicolai

Christine Mayer-Nicolai

Vice President, Regulatory and Scientific Policy, Merck Healthcare KGaA
Dr. Christine Mayer-Nicolai, VP, Regulatory & Scientific Policy at Merck Healthcare KGaA, Germany is based in Darmstadt and Washington, DC. She is leading the development of Merck Healthcare regulatory policy priorities, identifying, and responding to global regulatory and legislative... Read More →
avatar for Tamei Elliott

Tamei Elliott

Associate Director, Scientific Programs, DIA, United States
Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

1:45pm EDT

AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

This session will review the 3Rs (replacement, refinement, reduction) of animal use in non-clinical drug development research, and how new technologies including AI, Victorian Clinical Genetics Services (VCGs) and organoids are introducing innovative ways to meet these ethical principles.

Learning Objectives

Understand the “3Rs” (replacement, refinement, reduction) of ethical animal use in non-clinical drug development research; Review how new technologies including AI, VCGs and organoids are being explored to follow these ethical principles as part of the overall drug development program.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Julie Frearson


Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
JF

Julie Frearson

Senior Vice President, Chief Scientific Officer, Charles River Laboratories, United States
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Examine PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Evaluate the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Speakers
avatar for Edward Ian

Edward Ian

Senior Executive Officer, Mediscience Planning Inc., Japan
Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

1:45pm EDT

ICH Pharmaceutical Quality Knowledge Management Platform Global Regulatory Assessment and Industry-Vision to Reality
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.

Learning Objectives

Explain the drivers, purpose, and plan for the ICH hosted PQKM Collaboration Platform in your organization; Describe the platform operating framework under ICH including goveranance and operation for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.

Chair

David C. Isom

Speakers
DI

David Isom

Senior Director, Global Regulatory Policy and Intelligence, Pfizer Global Produc, Pfizer Inc
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

1:45pm EDT

Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.

Learning Objectives

Evaluate how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.

Chair

Juyoung Shin, PharmD, MPH

Speakers
avatar for Juyoung Shin

Juyoung Shin

Professor, College of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

1:45pm EDT

Africa's Evolving Regulatory Landscape
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Dialogue between key stakeholders on AMA operationalization, proposals on improved collaboration, regulatory harmonization and convergence, reliance pathways and other strategies for an efficient and sustainable regulatory system in the continent.

Learning Objectives

Evaluate progress made on AMA operationalization including achievements so far with the support of partners; Discuss key insights and lessons from the Continental Pilot; Identify the way forward for successful implementation of revised AU Model Law; Cultivating a sustainable regulatory ecosystem in Africa employing good regulatory practices and agilities as well as prioritizing capacity building.

Chair

Saba Berhane, BSN, MPharm

Speakers
SB

Saba Berhane

Manager, Regulatory Affairs, IFPMA, Switzerland
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

EMA Town Hall
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

In this session, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the regulators.

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Advanced

Operating models and company’s culture can affect an organization’s value and efficiency. This session will delve into Regulatory Affairs operating models, including opportunities and challenges, providing best practices for your organization.

Learning Objectives

Compare and contrast operating models being used by regulatory affairs organizations that are driving greater value, efficiency, and career empowerment; Understand successes and challenges with different operating models.

Chair

Alison Maloney, PhD, MBA, MS

Speakers
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs Americas, Bayer HealthCare Pharmaceuticals, United States
Alison Maloney is currently the Head of Regulatory Affairs Americas for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

4:00pm EDT

Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

Data privacy has been a long-standing challenge for RWD sharing and evidence generation across geography. This session will discuss privacy-preserving approaches that enable data access, sharing and collaboration in industry, academia and regulatory

Learning Objectives

Outline privacy-preserving approaches for accessing and sharing real-world data (RWD); Share use cases leveraging various applications (e.g., federated learning networks, synthetic data) in industry, academia and regulatory for RWE generation; Examine regulatory perspectives, methodological challenges and identify future development needs.

Chair

Echo Wang, DrPH, MPH

Speakers
EW

Echo Wang

Director, Outcome Research, Merck Co., United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

4:00pm EDT

Successful Patient Input to Regulatory and Health Technology Assessment Processes Along the Development Path: Examples of How to Optimize Impact
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

To guide patient focused drug development, patient input is sought by regulators and Health Technology Assessment (HTAs) in different ways around the world. The session will explore options to increase impact on development through greater coordination and information sharing.

Learning Objectives

Understand different options and processes for patient input into regulatory and HTA advice across key product development milestones. Explore best practices in maximising the overall impact of patient input on development plans. Identify policy and process changes that would allow continuous improvement and learning across the various set pieces for patient engagement.

Chair

Adam Heathfield, PhD

Speakers
avatar for Adam Heathfield

Adam Heathfield

Senior Director, Patient and Health Impact, Pfizer
Adam has worked for Pfizer for over 10 years. His current role is Senior Director in Pfizer’s Patient and Health Impact division. Previously, Adam has worked in Pfizer’s international policy division and led Pfizer’s work on science policy in Europe for several years. Adam initially... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session
 
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  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
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  • 04: MedAffairs-SciComm
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