Full Schedule

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