Full Schedule

7:00 AM - 4:00 PM EDT

Registration Hours

7:00 AM - 4:30 PM EDT

Speaker Ready Room Hours

7:30 AM - 8:30 AM EDT

Preconference Workshop Networking Breakfast & Welcome

8:30 AM - 4:00 PM EDT

Preconference Workshop: Behind the Curtain: A Practitioner's Field Guide to Global Health Authority Transparency for Drugs and Biologics

Workshop Leader: – Temple University School of Pharmacy

Workshop Presenter: – Pfizer

Pharmaceuticals (includes Biologics and Drugs)

8:30 AM - 4:00 PM EDT

Preconference Workshop: Drug Development in the EU: Regulatory Standards, Revisions in Legislation, and Support Activities

Workshop Leader: – Malta Medicines Authority

Workshop Presenter: – khhconsult

Workshop Presenter: – Malta Medicines Authority

Workshop Presenter: – European Medicines Agency

Workshop Presenter: – NDA Partners

Workshop Presenter: – Gilead Sciences

Pharmaceuticals (includes Biologics and Drugs)

8:30 AM - 4:00 PM EDT

Preconference Workshop: Briefing Books that Work: A Storyboarding Method for Meetings, Scientific Advice, and AdComs (Day 1 of 2)

Workshop Leader: – Moderna, Inc.

Workshop Presenter: – Eldridge Writing & Consulting

Workshop Presenter: – Parexel International

Workshop Presenter: – Ultragenyx Pharmaceutical

Workshop Presenter: – Astrazeneca

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Co-Development of Drugs and IVD/CDx: From Early Strategy to Commercial Success

Moderator/Presenter: – OBI Pharma

Moderator/Presenter: – GSK

Workshop Presenter: – IQVIA

Workshop Presenter: – Eli Lilly

Workshop Presenter: – Discovery Life Sciences

Pharmaceuticals (includes Biologics and Drugs)

8:30 AM - 4:00 PM EDT

Preconference Workshop: Survivor: The FDA 510(k) and De Novo 50Th Anniversary Program Edition (Day 1 of 2)

Moderator: – DuVal & Associates, P.A.

Presenter: – DuVal & Associates, P.A.

Presenter: – DuVal & Associates

Presenter: – Intuitive

Medical Devices

8:30 AM - 4:00 PM EDT

Preconference Workshop: The Ins and Outs of the Commission's MDR and IVDR Targeted Revision Proposal (Day 1 of 2)

Workshop Leader: – Axon Lawyers

Workshop Presenter: – Akra Team

Workshop Presenter: – QServe Group

Workshop Presenter: – TÜV SÜD Medical Health Services

Medical Devices

12:30 PM - 1:30 PM EDT

Preconference Workshops: Networking Lunch

7:00 AM - 4:30 PM EDT

Speaker Ready Room Hours

7:00 AM - 7:30 PM EDT

Registration Hours

7:30 AM - 8:30 AM EDT

Preconference Workshop Networking Breakfast & Welcome

8:30 AM - 4:00 PM EDT

Preconference Workshop: Briefing Books that Work: A Storyboarding Method for Meetings, Scientific Advice, and AdComs (Day 2 of 2)

Workshop Leader: – Moderna, Inc.

Workshop Presenter: – Eldridge Writing & Consulting

Workshop Presenter: – Parexel International

Workshop Presenter: – Ultragenyx Pharmaceutical

Workshop Presenter: – Astrazeneca

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Claiming Your Seat at the Table

Moderator: – Speicher Regulatory Services

Presenter: – Compliance-Alliance, LLC

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Ethics in Action: Practical Tools for Navigating Regulatory Dilemmas

Moderator: – Qserve Group

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Navigating Cell & Gene Therapy US, EU, and Japan Regulatory Strategies

Presenter: – Kenai Therapeutics

Pharmaceuticals (includes Biologics and Drugs)

8:30 AM - 4:00 PM EDT

Preconference Workshops: Regulatory Leadership Bootcamp: A Skills‑Based Accelerator for Early to Mid‑Career Professionals

Workshop Leader: – Integrated Project Management

Workshop Presenter: – APS Pharma Solutions, LLC

Workshop Presenter: – UCB Pharma

Workshop Presenter: – Integrated Project Management

Workshop Presenter: – Biodesix, Inc.

Workshop Presenter: – AstraZeneca

Workshop Presenter: – Regulatory Affairs Professional

Skill Building

8:30 AM - 4:00 PM EDT

Preconference Workshop: Survivor: The FDA 510(k) and De Novo 50Th Anniversary Program Edition (Day 2 of 2)

Moderator: – DuVal & Associates, P.A.

Presenter: – DuVal & Associates, P.A.

Presenter: – DuVal & Associates

Presenter: – Intuitive

Medical Devices

8:30 AM - 4:00 PM EDT

Preconference Workshop: The Ins and Outs of the Commission's MDR and IVDR Targeted Revision Proposal (Day 2 of 2)

Workshop Leader: – Axon Lawyers

Workshop Presenter: – Akra Team

Workshop Presenter: – QServe Group

Workshop Presenter: – TÜV SÜD Medical Health Services

Medical Devices

10:30 AM - 11:00 AM EDT

Preconference Workshops: Networking Break

12:30 PM - 1:30 PM EDT

Preconference Workshops: Networking Lunch

3:00 PM - 3:15 PM EDT

Preconference Workshops: Networking Break

3:00 PM - 4:00 PM EDT

Student Career Development Sesson

Student FocusSkill Building

4:30 PM - 6:00 PM EDT

RAPS Convergence 2026 Welcome & Opening Plenary

6:00 PM - 7:30 PM EDT

Opening Networking Reception & Welcome in the Exhibit Hall

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)

6:30 AM - 4:30 PM EDT

Speaker Ready Room Hours

7:00 AM - 8:00 AM EDT

Community Gathering (Continental Breakfast)

7:00 AM - 3:00 PM EDT

Registration Hours

8:00 AM - 9:00 AM EDT

Morning Plenary Session

9:15 AM - 10:30 AM EDT

Beyond Technical Expertise: Power Skills for Regulatory Leadership and Career Growth

Presenter: – Compliance-Alliance, LLC

Presenter: – AstraZeneca

Presenter: – Hologic Inc

Skill Building

9:15 AM - 10:30 AM EDT

EU Pharma Legislation Update

Pharmaceuticals (includes Biologics and Drugs)

9:15 AM - 10:30 AM EDT

IMDRF Overview

Medical Devices

9:15 AM - 10:30 AM EDT

Move Real-World Evidence from Buzzword to Valuable Regulatory Asset

Presenter: – Qserve Consultancy B.V.

Presenter: – Johnson&Johnson MedTech Surgery

Presenter: – US Food and Drug Administration

Moderator: – Veeva MedTech

Medical Devices

9:15 AM - 10:30 AM EDT

New Session Topic: Post Approval Changes

Presenter: – AstraZeneca

Presenter: – Daiichi Sankyo

Pharmaceuticals (includes Biologics and Drugs)

9:15 AM - 10:30 AM EDT

Optimizing Regulatory Strategies to Mitigate Drug Shortages Throughout the Lifecycle of an Approved Drug Product

Presenter: – Pharmaceutical Company

Pharmaceuticals (includes Biologics and Drugs)

9:15 AM - 10:30 AM EDT

Unifying Drug and Device Change Management Frameworks - A US Focus

Presenter: – BD

Presenter: – NOMSA Regulatory and Writing LLC

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 - 3:30 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 (Repeat)

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 (Repeat)

Facilitator: – HMC-regulation

Pharmaceuticals (includes Biologics and Drugs)Solutions Circle

10:35 AM - 11:05 AM EDT

Solutions Circle: URRA vs. Hazard Analysis: Aligning Scope, Format, and Expectations

Facilitator: – Bridging Consulting LLC

Medical DevicesSolutions Circle

11:10 AM - 11:40 AM EDT

Solutions Circle: eSTAR in Practice: What Actually Works (and What Doesn't)

Facilitator: – Zimmer Biomet

Medical DevicesSolutions Circle

11:10 AM - 11:40 AM EDT

Solutions Circle: The Invisible Dossier: Networking as a Regulatory Requirement (Repeat)

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 (Repeat)

Facilitator: – Only Orphans Cote, LLC

Pharmaceuticals (includes Biologics and Drugs)Solutions Circle

11:30 AM - 1:00 PM EDT

Networking Lunch in Exhibit Hall

11:45 AM - 12:15 PM EDT

Solutions Circle: FDA-Required Safety Labeling Changes: Navigating the Agency's New Guidance

Facilitator: – Leavitt Partners

Pharmaceuticals (includes Biologics and Drugs)Solutions Circle

11:45 AM - 12:15 PM EDT

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

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 (Repeat)

Facilitator: – Recor Medical, Inc.

Skill BuildingSolutions Circle

11:45 AM - 12:15 PM EDT

Solutions Circle: Regulatory Challenges and Opportunities in Companion Diagnostics Clinical Trials

Facilitator: – Qserve Consultancy

In Vitro DiagnosticsSolutions Circle

12:20 PM - 12:50 PM EDT

Solutions Circle: Navigating Lay Language 2026 and Beyond

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 (Repeat)

Facilitator: – QARA Solutions, LLC

Skill BuildingSolutions Circle

12:20 PM - 12:50 PM EDT

Solutions Circle: Understanding the Medical Devices Approvals by the Reliance Route in Brazil: Criteria & Benefits

Facilitator: – Vera Rosas Group

Medical DevicesSolutions Circle

1:00 PM - 2:00 PM EDT

EMEA Regional Updates

Medical Devices

1:00 PM - 2:00 PM EDT

Enhancing Medical Device Safety Through Implementing Cybersecurity Guidance

Presenter: – Thermo Fisher Scientific

Presenter: – Olympus Technologies of America

Presenter: – CyberMed

Medical Devices

1:00 PM - 2:00 PM EDT

FDA Forecast 2027: What the FDA Has in Store for Pharmaceuticals and Biotechnology Products

Moderator: – Accumulus Synergy

Panelist: – Esham Strategies

Panelist: – AgencyIQ

Panelist: – Citeline

Pharmaceuticals (includes Biologics and Drugs)

1:00 PM - 2:00 PM EDT

How to Conduct Successful Interviews

Skill Building

1:00 PM - 2:00 PM EDT

China Evolving Drug Regulatory Landscape: Traditional Pathways, Regulatory Updates, and Emerging Roles of AI and Real-World Data

Presenter: – Cisema

Presenter: – Cisema (Hong Kong) Limited

Pharmaceuticals (includes Biologics and Drugs)

1:00 PM - 2:00 PM EDT

New Session Topic: Wearables

Presenter: – Hologic Inc

Presenter: – Analog Devices

Presenter: – Google LLC

Presenter: – SGS

Medical Devices

1:00 PM - 2:00 PM EDT

The Economics of Compliance Where International Trade Intersects with cGMP

Presenter: – Nelson Mullins Riley & Scarborough LLP

Pharmaceuticals (includes Biologics and Drugs)

2:00 PM - 2:30 PM EDT

Networking Refreshment Break in Exhibit Hall

2:00 PM - 3:15 PM EDT

Exclusive Exhibit Hall Hours: Networking & Presentations

2:00 PM - 3:15 PM EDT

Student Capstone Poster Display: From First Aid to Performance Aid: Regulating Smelling Salts in Sports

Poster Presenter: – Northeastern University

Student FocusPharmaceuticals (includes Biologics and Drugs)

2:00 PM - 3:15 PM EDT

Student Capstone Poster Display: Regulatory and Operational Impact of Decentralized Clinical Trials on Development Efficiency and Market Access

Poster Presenter: – Northeastern University

Student FocusPharmaceuticals (includes Biologics and Drugs)

2:00 PM - 3:15 PM EDT

Student Capstone Poster Display: Emerging Challenges in African Regulatory Systems: Insights from FDA Ghana for Global Regulators

Poster Presenter: – Northeastern University

Student FocusOther

2:00 PM - 3:15 PM EDT

Student Capstone Presentation: Bridging the Regulatory Chasm: A Global Harmonized Framework (GHF) for AI-Augmented Pharmacovigilance

Student Presenter: – ChatMedSafe | MS Candidate, LIU

Student FocusPharmaceuticals (includes Biologics and Drugs)

2:00 PM - 3:15 PM EDT

Student Capstone Presentation: Evaluating 3rd Party Pre-Trained AI Models for use in Software Development of Medical Devices

Student Presenter: – DkIT

Student FocusMedical Devices

2:00 PM - 3:15 PM EDT

Student Capstone Presentation: Navigating Legal Landscape for Operationalizing Site Specific Acceptance Testing of FDA Authorized AI Medical Devices

Student Presenter: – Azurity Pharmaceuticals

Student FocusMedical Devices

2:00 PM - 3:15 PM EDT

Student Capstone Presentation: Pharmaceutical liability in commercial spaceflight: rethinking the duty to warn in microgravity

Student Presenter: – Northeastern University

Student FocusPharmaceuticals (includes Biologics and Drugs)

2:00 PM - 3:15 PM EDT

Student Capstone Presentation: Preparing for the EU AI Act: Regulatory Readiness for Medical Devices and Software

Student Presenter: – Medical device

Student FocusMedical Devices

2:00 PM - 3:15 PM EDT

Student Capstone Presentation: Turning Compliance into Competitive Advantage: AI-Driven Regulatory Pathways for Medical Device Innovators

Student Presenter: – Northeastern University

Student FocusMedical Devices

2:30 PM - 2:50 PM EDT

Solutions Circle: Navigating the UK Regulatory Landscape: UK MDR Amendments and Impact Incl Alternative Routes

Facilitator: – BSI

Medical DevicesSolutions Circle

2:30 PM - 2:50 PM EDT

Solutions Circle: Regulatory CMC Agency Queries and RFIs

Facilitator: – USP

Pharmaceuticals (includes Biologics and Drugs)Solutions Circle

3:15 PM - 4:15 PM EDT

Achieving the Fastest Simultaneous Global Filings: the Tarlatamab Blueprint

Moderator: – Amgen Inc

Pharmaceuticals (includes Biologics and Drugs)

3:15 PM - 4:15 PM EDT

Closing the Gap: Timely Evidence for Pregnancy and Breastfeeding in Clinical Trials

Moderator: – UCB Biosciences, Inc.

Presenter: – UCB Biopharma SRL

Pharmaceuticals (includes Biologics and Drugs)

3:15 PM - 4:15 PM EDT

Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation

Moderator: – Axon Lawyers

Presenter: – Smith+Nephew

Medical Devices

3:15 PM - 4:15 PM EDT

From Profile to Post: Making LinkedIn Work for Your Career

Presenter: – Intuitive Surgical

Presenter: – Elemed

Skill Building

3:15 PM - 4:15 PM EDT

Navigating the New US & EU Rare Disease Regulatory Framework and Global Harmonization Efforts

Session Leader: – Novo Nordisk

Presenter: – The National Academies of Sciences, Engineering, and Medicine

Presenter: – National Organization for Rare Disorders (NORD)

Pharmaceuticals (includes Biologics and Drugs)

3:15 PM - 4:15 PM EDT

Advancing IVD Development Under Real-World Constraints: Regulatory Flexibility in EU Combined Studies and US Validation Strategies

Presenter: – Thermo Fisher Scientific

Presenter: – Goldbug Strategies LLC

Medical Devices

3:15 PM - 4:15 PM EDT

Predetermined Change Control Plans (PCCPs) Across the Device Lifecycle: From Premarket Strategy to Postmarket Execution

Moderator: – Bridging Consulting LLC

Panelist: – Hogan Lovells

Panelist: – Medtronic

Panelist: – MCRA, an IQVIA Company

Panelist: – Beacon Biosignals

Medical Devices

4:30 PM - 5:30 PM EDT

Advertisement & Promotional Materials: Making Decisions in an Ambiguous World

Moderator: – QARA Solutions, LLC

Panelist: – RNB Ventures Consulting, Inc.

Panelist: – Siemens Healthineers North America

Panelist: – Avanos Medical, Inc.

Medical Devices

4:30 PM - 5:30 PM EDT

Best Practices in MDR/IVDR Conformity Assessment Processes: Lessons Learned for SaMD and AI-Integrated Medical Devices

Moderator: – DNV

Presenter: – BSI Group

Presenter: – ELEKTA

Presenter: – Axon Lawyers

Medical Devices

4:30 PM - 5:30 PM EDT

Global Regulatory Convergence for Artificial Intelligence in the Medical Product Lifecycle

Moderator: – EMD Serono

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

4:30 PM - 5:30 PM EDT

Leveraging CRL Trends to Streamline Submissions and Market Access

Moderator: – USP

Pharmaceuticals (includes Biologics and Drugs)

4:30 PM - 5:30 PM EDT

Navigating FDA Biocompatibility: From Strategy to Successful Submission in the New Era

Moderator: – MedTech

Presenter: – Medtronic

Medical Devices

4:30 PM - 5:30 PM EDT

Advancing Pediatric Rare Disease Drug Development: Overcoming Scientific, Regulatory, and Operational Barriers Across Neonatal and Oncology Indications

Session Leader: – Critical Path Institute

Presenter: – AstraZeneca

Presenter: – Critical Path Institute

Pharmaceuticals (includes Biologics and Drugs)

4:30 PM - 5:30 PM EDT

Utilizing Non-COA Patient Experience Data in Drug Development and Regulatory Decision-Making: Recent and Emerging Developments

Moderator: – Eli Lilly and Company

Panelist: – Pfizer

Panelist: – Sanofi

Pharmaceuticals (includes Biologics and Drugs)

6:00 PM - 9:00 PM EDT

RAPS Convergence 50th Anniversary & Closing Party Celebration at NASCAR Hall of Fame