Full Schedule

6:30 AM - 5:30 PM EDT

Registration Hours

6:30 AM - 5:30 PM EDT

Speaker Ready Room Hours

7:00 AM - 8:00 AM EDT

Community Gathering (Continental Breakfast)

8:00 AM - 9:00 AM EDT

Morning Plenary Session

9:15 AM - 10:15 AM EDT

Advancing Representation in Clinical Trials: Scientific and Operational Strategies for Population-Reflective Enrollment

Moderator: – EMD Serono

Panelist: – Genentech

Panelist: – Health Tequity

Panelist: – P1 Pratia Oncology

Pharmaceuticals (includes Biologics and Drugs)

9:15 AM - 10:30 AM EDT

Back by Popular Demand: The Evolution of U.S. and EU Regulatory Policies and Excellence

Moderator: – MedTech

Panelist: – Agency IQ

Panelist: – Arnold Porter

Medical Devices

9:15 AM - 10:30 AM EDT

Biomarker‑Based Endpoints in Drug Development: Scientific Rigor and Regulatory Perspectives

Presenter: – UCB

Presenter: – AstraZeneca

Pharmaceuticals (includes Biologics and Drugs)

9:15 AM - 10:30 AM EDT

Diverse Women in Regulatory Affairs: Leadership and Career Pathways

Session Leader: – Medtronic

Panelist: – APS Pharma Solutions, LLC

Panelist: – RAPS North Carolina Local Networking Group

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

9:15 AM - 10:30 AM EDT

New Session Topic: Accelerated Drug Development

Presenter: – QbD Group

Presenter: – Sanofi

Presenter: – Ipsen

Pharmaceuticals (includes Biologics and Drugs)

9:15 AM - 10:30 AM EDT

IVDR, Quo Vadis? Revising the In Vitro Diagnostics Regulation.

Presenter: – ThermoFisher

Presenter: – QServe Group

Presenter: – TÜV SÜD

Presenter: – IVDR Solutions LLC

Medical Devices

9:15 AM - 10:30 AM EDT

Small Manufacturers Challenges and Lessons Learned

Moderator: – Intuitive Surgical

Presenter: – TÜV SÜD

Presenter: – Qserve Group

Medical Devices

10:30 AM - 11:00 AM EDT

Networking Refreshment Break in Exhibit Hall

10:30 AM - 1:00 PM EDT

Exclusive Exhibit Hall Hours: Networking & Presentations

10:30 AM - 4:30 PM EDT

Exhibit Hall Hours

10:35 AM - 11:05 AM EDT

Solutions Circle: Including Regulatory Requirements in Partnership Agreements for Joint Drug and Combination Product Development

Facilitator: – Ascendis Pharma

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)Solutions Circle

10:35 AM - 11:05 AM EDT

Solutions Circle: Maximizing the Potential of Meetings with the FDA

Facilitator: – HMC-regulation

Pharmaceuticals (includes Biologics and Drugs)Solutions Circle

10:35 AM - 11:05 AM EDT

Solutions Circle: QMSR Transition: What Gaps Are Manufacturers Underestimating and How to Prioritize Remediation

Facilitator: – Becton, Dickinson and Company

Medical DevicesSolutions Circle

11:10 AM - 11:40 AM EDT

Solutions Circle: FDA Pre-Submission Strategy: How to Plan, Execute, and Maximize Regulatory Feedback

Facilitator: – MelioLabs Inc

Medical DevicesSolutions Circle

11:10 AM - 11:40 AM EDT

Solutions Circle: The Invisible Dossier: Networking as a Regulatory Requirement

Facilitator: – Regulatory Affairs Professional

Skill BuildingSolutions Circle

11:10 AM - 11:40 AM EDT

Solutions Circle: When is the Same Moiety Different? The Clinical Superiority Provisions of FDA's Orphan Drug Regulations

Facilitator: – Only Orphans Cote, LLC

Pharmaceuticals (includes Biologics and Drugs)

11:30 AM - 1:00 PM EDT

Networking Lunch in Exhibit Hall

11:45 AM - 12:15 PM EDT

Solutions Circle: Breakthrough Designation: Is It Right for Your Device?

Facilitator: – Insulet

Medical DevicesSolutions Circle

11:45 AM - 12:15 PM EDT

Solutions Circle: The US Reimbursement Landscape: Understanding Shifts and Changes in the Drug Pricing Narrative

Facilitator: – Keenova

Pharmaceuticals (includes Biologics and Drugs)Solutions Circle

11:45 AM - 12:15 PM EDT

Solutions Circle: The Volunteer Sandbox: Accelerating Regulatory Leadership through RAPS

Facilitator: – Recor Medical, Inc.

Skill BuildingSolutions Circle

12:20 PM - 12:50 PM EDT

Solutions Circle: From Access to Insight: A Call for Transparency and Disclosure

Facilitator: – Veristat

Pharmaceuticals (includes Biologics and Drugs)Solutions Circle

12:20 PM - 12:50 PM EDT

Solutions Circle: Reg Ops to Reg Strategy and Everything In-Between: How to Become a Well-Rounded RA Professional

Facilitator: – QARA Solutions, LLC

Skill BuildingSolutions Circle

12:20 PM - 12:50 PM EDT

Solutions Circle: Submission Strategies for Medical Devices in Brazil - Submission Pathways & Ongoing Challenges

Facilitator: – Vera Rosas Group

Medical DevicesSolutions Circle

1:00 PM - 2:00 PM EDT

Animal Health Drugs: The Approval & Lifecyle Process

Moderator: – Temple University

Presenter: – University of Georgia

Presenter: – Edge Animal Health, Inc

Pharmaceuticals (includes Biologics and Drugs)

1:00 PM - 2:00 PM EDT

Clinical Data Transferability: Strategies for Utilizing Cross-Regional Evidence in Regulatory Submissions

Panelist: – AKRA Team GmbH

Panelist: – BSI

Panelist: – Cerapedics, Inc.

Panelist: – US Food and Drug Administration

Medical Devices

1:00 PM - 2:00 PM EDT

New Session Topic: China Device Updates

Presenter: – Cisema

Presenter: – Intuitive Surgical, Inc.

Presenter: – China Med Device

Medical Devices

1:00 PM - 2:00 PM EDT

New Session Topic: CMC

Presenter: – Formerly Metagenomi

Presenter: – Cytiva

Pharmaceuticals (includes Biologics and Drugs)

1:00 PM - 2:00 PM EDT

New Session Topic: MDR/IVDR State of Play

Presenter: – TÜV SÜD Medical Health Services

Presenter: – QServe Group

Presenter: – Akra Team

Presenter: – Axon Lawyers

Medical Devices

1:00 PM - 2:00 PM EDT

Regulatory Mentoring in the Workplace

Moderator: – AZ Technica

Presenter: – Critical Path Institute

Skill Building

2:15 PM - 3:15 PM EDT

Financial Literacy for Regulatory Affairs

Presenter: – Speicher Regulatory Services

Skill Building

2:15 PM - 3:15 PM EDT

Impact of AI on Regulatory Workforce.

Presenter: – Veeva Systems

Presenter: – TÜV SÜD

Presenter: – Siemens Healthineers AG

Medical Devices

2:15 PM - 3:15 PM EDT

In-Silico Trials - Global Perspectives and Solutions

Moderator: – Synopsys

Presenter: – TÜV SÜD

Presenter: – Becton Dickinson

Presenter: – Edwards Lifesciences

Presenter: – MHRA

Medical Devices

2:15 PM - 3:15 PM EDT

Leveraging External Controls to Advance Global Regulatory Decision-Making

Moderator: – Duke

Presenter: – Amgen

Pharmaceuticals (includes Biologics and Drugs)

2:15 PM - 3:15 PM EDT

New Approach Methodologies (NAMs) in Preclinical Drug Development: Discussion of the Current Global Regulatory Landscape

Presenter: – UCB Pharma

Presenter: – OBI Pharma USA Inc.

Pharmaceuticals (includes Biologics and Drugs)

2:15 PM - 3:15 PM EDT

FDA’s “Crackdown” on Direct-to-Consumer Prescription Drug Advertising – One Year Later

Panelist: – APS Pharma Solutions, LLC

Panelist: – Propharma Group

Panelist: – Compliance Forward, LLC

Panelist: – AgencyIQ

Pharmaceuticals (includes Biologics and Drugs)

2:15 PM - 3:15 PM EDT

New Session Topic: MDR Transition

Moderator: – TÜV SÜD Medical Health Services

Presenter: – QServe Group

Presenter: – Akra Team

Presenter: – GMED North America, Inc.

Medical Devices

2:15 PM - 3:15 PM EDT

Sticky Wickets in Statutory Authority: CDER’s Workarounds, Remote Participation, and the Legal Limits of FDA Inspection Power

Presenter: – Exela Pharma Sciences

Pharmaceuticals (includes Biologics and Drugs)

3:15 PM - 3:45 PM EDT

Networking Refreshment Break in Exhibit Hall

3:15 PM - 4:30 PM EDT

Exclusive Exhibit Hall Hours: Networking & Presentations

4:00 PM - 4:30 PM EDT

Solutions Circle: How to 10x Productivity as a Regulatory Affairs Professional using AI

Facilitator: – Artos

Skill BuildingSolutions Circle

4:00 PM - 4:30 PM EDT

Solutions Circle: Navigating Social Media in Pharmacovigilance: Regulatory Uncertainty, Data Challenges, and Strategic Considerations for RA Professionals

Facilitator: – Leavitt Partners

Pharmaceuticals (includes Biologics and Drugs)Solutions Circle

4:00 PM - 4:30 PM EDT

Solutions Circle: Risk Assessment: Common Failures in Identification and Implementation of ISO 14971 as Seen by NBs

Facilitator: – SGS

Medical DevicesSolutions Circle

4:30 PM - 5:30 PM EDT

FemTech and Beyond: Addressing Sex-Based Disparities in Medical Devices and Pharmaceuticals

Presenter: – Intuitive Surgical

Presenter: – EPAM Systems

Presenter: – AdvaMed

Medical Devices

4:30 PM - 5:30 PM EDT

Global Biosimilarity Assessments: Key Regulatory Changes Impacting Biosimilar Development Strategy

Presenter: – KM Intel LLC

Presenter: – Cytiva

Pharmaceuticals (includes Biologics and Drugs)

4:30 PM - 5:30 PM EDT

ICH M4Q(R2) as the Inflection Point: Digitizing CMC Submissions and Operationalizing Responsible AI/ML

Moderator: – Moderna, Inc.

Presenter: – Middlesex Consulting Group

Presenter: – FDA / CDER / OPQ / OPQAII

Pharmaceuticals (includes Biologics and Drugs)

4:30 PM - 5:30 PM EDT

Navigating Global eIFU Excellence: Leveraging US and EU Best Practices for Strategic Implementation

Moderator: – AKRA TEAM GmbH

Panelist: – DNV Business Assurance USA Inc.

Panelist: – Innovatum Inc.

Panelist: – Arthrex

Panelist: – meddevo

Medical Devices

4:30 PM - 5:30 PM EDT

Managing global UDI compliance effectively and getting ahead of EUDAMED Implementation Timelines: Implications for Regulatory Information Management

Moderator: – USDM Life Sciences

Presenter: – osapiens

Presenter: – Veeva Medtech

Presenter: – Smith+Nephew

Presenter: – BSI

Medical Devices

4:30 PM - 5:30 PM EDT

The Convergence of Regulatory and Politics: A Closer Look at Congressional Proposals to Reform FDA

Moderator: – AgencyIQ

Presenter: – Agency IQ

Broad Interest (Cannabidiol, Health-Related Foods, AI, Cybersecurity, Data Transparency, Inspections & Audits)

5:45 PM - 7:15 PM EDT

Honoring Excellence: RAPS 2026 Awards Celebration (Invitation Only)

7:30 PM - 10:00 PM EDT

Convergence Networking Party at Monarch Market (Separate Ticket Purchase Required to Attend)