Full Schedule

7:00 AM - 4:00 PM EST

Convergence App Support Hours

Location/Room: Concourse A, at Registration Desk

7:00 AM - 4:00 PM EST

First Aid Office Hours

Location/Room: Near Room 301, Level 3

7:00 AM - 4:00 PM EST

Registration Hours

Location/Room: Concourse A, Level 2

7:00 AM - 4:00 PM EST

Wellness Room

Location/Room: Near RAPS Store, Level 2

7:00 AM - 4:30 PM EST

Speaker Ready Room

Location/Room: 307

7:30 AM - 8:30 AM EST

Preconference Workshops: Networking Breakfast & Welcome

Location/Room: East Atrium, Level 3

Preconference Workshop

8:30 AM - 4:00 PM EST

Preconference Workshop: Expand Your Knowledge to Gain Professional Flexibility

Location/Room: 406

Workshop Presenter: – AKRA TEAM

Workshop Presenter: – TÜV SÜD

Workshop Presenter: – QServe Group

Workshop Presenter: – QualityHub

Workshop Presenter: – Axon Lawyers

Devices (includes Medical Devices & In Vitro Diagnostics)

8:30 AM - 4:00 PM EST

Preconference Workshop: Claiming Your Seat at the Table: How to Be Included in All Strategic Business Decisions

Location/Room: 301

Workshop Leader: – Compliance-Alliance, LLC

Workshop Presenter:

Workshop Presenter: – Regulatory Affairs Professionals Society (RAPS)

Workshop Presenter: – Ascendis Pharma, Inc.

Workshop Presenter:

Workshop Presenter: – QuidelOrtho

Broad Interest & Skill Building

8:30 AM - 4:00 PM EST

Preconference Workshop: Drug Development in the EU: Regulatory Standards, Supports, and New Approaches

Location/Room: 302

Workshop Leader: – Malta Medicines Authority

Workshop Presenter: – khhconsult

Workshop Presenter: – European Medicines Agency

Workshop Presenter: – Malta Medicines Authority

Workshop Presenter: – NDA Partners

Workshop Presenter: – Malta Medicines Authority

Pharmaceuticals (includes Biologics & Drugs)

8:30 AM - 4:00 PM EST

Preconference Workshop: Locating and Analyzing Regulatory Precedent; Incorporating Research and Application Techniques in Strategic Regulatory Decision Making

Location/Room: 401

Workshop Leader: – Temple University

Workshop Presenter: – Pfizer

Workshop Presenter: – BeOne Medicines

Workshop Presenter: – Genmab US

Workshop Presenter: – Temple University

Pharmaceuticals (includes Biologics & Drugs)

8:30 AM - 4:00 PM EST

Preconference Workshop: Survivor: The FDA 510(k) Program Edition (Day 1 of 2)

Location/Room: 315

Workshop Leader: – DuVal & Associates, P.A.

Workshop Presenter: – DuVal & Associates, P.A.

Workshop Presenter: – RQM+

Workshop Presenter: – Intuitive

Workshop Presenter:

Devices (includes Medical Devices & In Vitro Diagnostics)

10:30 AM - 11:00 AM EST

Preconference Workshops: Networking Break

Location/Room: East Atrium, Level 3

Preconference Workshop

12:30 PM - 1:30 PM EST

Preconference Workshops: Networking Lunch

Location/Room: East Atrium, Level 3

Preconference Workshop

3:00 PM - 3:15 PM EST

Preconference Workshops: Afternoon Break

Location/Room: East Atrium, Level 3

Preconference Workshop

7:00 AM - 4:30 PM EST

Speaker Ready Room

Location/Room: 307

7:00 AM - 7:00 PM EST

Wellness Room

Location/Room: Near RAPS Store, Level 2

7:00 AM - 7:30 PM EST

Convergence App Support Hours

Location/Room: Concourse A, at Registration Desk

7:00 AM - 7:30 PM EST

Registration Hours

Location/Room: Concourse A, Level 2

7:00 AM - 8:00 PM EST

First Aid Office Hours

Location/Room: Near Room 301, Level 3

7:30 AM - 8:30 AM EST

Preconference Workshops: Networking Breakfast & Welcome

Location/Room: East Atrium, Level 3

Preconference Workshop

8:00 AM - 6:00 PM EST

RAPS Store & Hours

Location/Room: Concourse A, Registration Area

8:30 AM - 4:00 PM EST

Preconference Workshop: AI Across Pharma and Devices: Navigating Innovation, Risk, and Compliance as Regulatory Professionals

Location/Room: 301

Workshop Leader: – Summit Therapeutics

Workshop Presenter: – Analog Devices

Workshop Presenter: – Artos

Pharmaceuticals (includes Biologics & Drugs)

8:30 AM - 4:00 PM EST

Preconference Workshop: Change Management on MDR and IVDR

Location/Room: 401

Workshop Leader: – AKRA TEAM

Workshop Presenter: – Johnson & Johnson Medtech

Workshop Presenter: – Medtronic

Workshop Presenter: – GMED Certification Division

Devices (includes Medical Devices & In Vitro Diagnostics)

8:30 AM - 4:00 PM EST

Preconference Workshop: Implement Changes to Approved Biologic Drug Manufacturing and Controls Using Risk-Based Regulatory Approaches

Location/Room: 406

Workshop Leader: – Millipore Sigma

Workshop Presenter: – Teva Pharmaceuticals

Pharmaceuticals (includes Biologics & Drugs)

8:30 AM - 4:00 PM EST

Preconference Workshop: Strategy and Regulatory Intelligence Primer: Constructing and Maintaining it Using Free and Fee AI Tools

Location/Room: 403

Workshop Leader: – Regulatorium

Workshop Presenter: – Recursion

Workshop Presenter: – LunarLanding.AI LLC

Workshop Presenter: – University of Maryland

Workshop Presenter:

Broad Interest & Skill Building

8:30 AM - 4:00 PM EST

Preconference Workshop: Survivor: The FDA 510(k) Program Edition (Day 2 of 2)

Location/Room: 315

Workshop Leader: – DuVal & Associates, P.A.

Workshop Presenter: – DuVal & Associates, P.A.

Workshop Presenter: – RQM+

Workshop Presenter: – Intuitive

Workshop Presenter:

Devices (includes Medical Devices & In Vitro Diagnostics)

10:30 AM - 11:00 AM EST

Preconference Workshops: Networking Break

Location/Room: East Atrium, Level 3

Preconference Workshop

12:30 PM - 1:30 PM EST

Preconference Workshops: Networking Lunch

Location/Room: East Atrium, Level 3

Preconference Workshop

3:00 PM - 3:15 PM EST

Preconference Workshops: Afternoon Break

Location/Room: East Atrium, Level 3

Preconference Workshop

3:00 PM - 4:00 PM EST

Career Development Session for Students

Location/Room: 317

Presenter: – Neuros Medical

Student Focus

4:30 PM - 6:00 PM EST

RAPS Convergence 2025 Welcome & Opening Plenary: A Love Letter to Science: Rebuilding Trust Through Transparency and Empathy

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Moderator / Speaker: – Thermo Fisher Scientific

Speaker: – Pfizer

Speaker: – Regulatory Affairs Professionals Society (RAPS)

Sponsor Speaker: – Celegence

Speaker: – Ascendis Pharma, Inc.

Panelist: – Drexel University

Panelist: – Medical Alley

Panelist: – Johns Hopkins Bloomberg School of Public Health

6:00 PM - 7:30 PM EST

Opening Reception & Welcome in the Exhibit Hall

Location/Room: Exhibit Hall A, Level 2

6:30 AM - 5:00 PM EST

Speaker Ready Room

Location/Room: 307

6:30 AM - 5:30 AM EST

Convergence App Support Hours

Location/Room: Concourse A, at Registration Desk

6:30 AM - 5:30 PM EST

Registration Hours

Location/Room: Concourse A, Level 2

6:30 AM - 5:30 PM EST

Wellness Room

Location/Room: Near RAPS Store, Level 2

7:00 AM - 8:00 AM EST

Community Gathering & Morning Coffee

Location/Room: Regional Gallery, Level 3

7:00 AM - 6:00 PM EST

First Aid Office Hours

Location/Room: Near Room 301, Level 3

7:00 AM - 6:00 PM EST

RAPS Store & Hours

Location/Room: Concourse A, Registration Area

8:00 AM - 9:00 AM EST

Plenary Session: Bridging the Access Gaps: Regulatory Pathways to Equitable Innovation

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Speaker: – Thermo Fisher Scientific

Sponsor Speaker: – Rimsys

Moderator: – Veeva MedTech

Panelist: – AKRA TEAM

Panelist: – Medtronic

Panelist: – Korion Health

9:15 AM - 10:30 AM EST

Enhancing Understanding of Biologic Variability Through Representation in Clinical Trials

Location/Room: 403

Moderator: – EMD Serono

Presenter: – F. Hoffmann-La Roche Ltd

Presenter: – Novotech

Presenter: – HealthTequity

Presenter: – Community Liver Alliance

Presenter (Remote): – Pfizer

Pharmaceuticals (includes Biologics & Drugs)

9:15 AM - 10:30 AM EST

Advertisement & Promotional Material

Location/Room: 301

Moderator: – QARA Solutions, LLC

Presenter: – RNB Ventures Consulting

Presenter: – Avanos Medical, Inc.

Presenter: – Siemens Healthineers

Devices (includes Medical Devices & In Vitro Diagnostics)

9:15 AM - 10:30 AM EST

Embracing the Age of Generative AI in Drug Development

Location/Room: 401

Presenter: – Thermo Fisher Scientific

Presenter: – Biogen

Presenter: – TrialAssure

Presenter (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

9:15 AM - 10:30 AM EST

EU MDR Kick-Off: “The Latest and Greatest News from Europe

Location/Room: 304

Presenter: – TÜV SÜD

Presenter: – QServe Group

Presenter: – AKRA TEAM

Presenter: – GMED North America

Presenter: – Abbott

Presenter: – Axon Lawyers

Devices (includes Medical Devices & In Vitro Diagnostics)

9:15 AM - 10:30 AM EST

Expedited Programs to Support the Development and Approval of Products for Unmet Medical Needs

Location/Room: 317

Presenter: – HMC-regulation

Presenter: – Ipsen

Presenter: – Apath Nexus

Presenter (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

9:15 AM - 10:30 AM EST

Government Career Transitions Forum

Location/Room: 315

Panel Facilitator: – BioMarin Pharmaceutical, Inc.

Panelist: – QualityHub

Panelist: – ELIQUENT Life Sciences

Panelist: – RAPS BoD

Broad Interest & Skill Building

9:15 AM - 10:30 AM EST

Health Authority Forum: Europe Forum, European Medicines Agency (EMA) & European Regulatory Network

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Presenter: – European Medicines Agency

Presenter: – Malta Medicines Authority

Health Authority

9:15 AM - 10:30 AM EST

The Power of Mentorship in Regulatory Affairs

Location/Room: 406

Presenter: – Neuros Medical

Presenter: – Insulet Corporation

Presenter: – UCB

Presenter: – Boston Scientific Corporation

Broad Interest & Skill Building

10:30 AM - 11:00 AM EST

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall A, Level 2

10:30 AM - 11:15 AM EST

RAPS Chapter/LNG Meet & Greets in Career Central

Location/Room: Exhibit Hall: Booth 145

RAPS in the Exhibit HallCareer Central

10:30 AM - 1:00 PM EST

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall A, Level 2

10:30 AM - 1:00 PM EST

Pawsitive Reinforcement

Location/Room: Exhibit Hall: Booth 1013

Supported by

10:30 AM - 4:30 PM EST

Exhibit Hall Open Hours

Location/Room: Exhibit Hall A, Level 2

10:30 AM - 4:30 PM EST

RAPS Sales Lounge Hours

Location/Room: Exhibit Hall: Booth 1017

10:35 AM - 11:05 AM EST

Solutions Circle (C): Interested in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of Volunteering

Solutions Circle repeats on Wednesday and Thursday

Location/Room: Exhibit Hall: Solutions Circle C

Facilitator: – Kenai Therapeutics

Repeat Solutions CircleBroad Interest & Skill Building

10:35 AM - 11:05 AM EST

Solutions Circle (A): Regulatory Consulting-Ins and Outs

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – APS Pharma Solutions, LLC

Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)

10:35 AM - 11:05 AM EST

Solutions Circle (D): Sponsored Solutions Circle: Put Your Model to the Test: Exploring Off-the-Shelf AI for Medical Devices

Location/Room: Exhibit Hall: Solutions Circle D

Sponsor Facilitator: – Ketryx

Sponsor Solutions Circle

Facilitated by

10:45 AM - 11:10 AM EST

Sponsored Presentation: AI for EU MDR-compliant clinical evaluation reports: Tools, tactics, and compliance insights

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – Celegence

Sponsor Presentation

Presented By

10:45 AM - 11:10 AM EST

Sponsored Presentation: Proactivity and best practices in the evolving FDA landscape

Location/Room: Exhibit Hall: Ignite! Theater Booth 925

Speaker: – Allucent

Sponsor Presentation

Presented By

10:45 AM - 11:10 AM EST

Sponsored Presentation: Transforming regulatory content with AI and ML: Enhancing compliance and patient safety in a Digital Era

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – Glemser Technologies

Sponsor Presentation

Presented By

10:45 AM - 11:45 AM EST

Career Central Stage: RAPS Credentials: Create an Actionable Roadmap for you and your team

Location/Room: Exhibit Hall: Booth 145

Presenter: – RAPS

RAPS in the Exhibit HallCareer Central Stage

11:00 AM - 11:30 AM EST

RAPS Central Board Round Up: How to Become a RAPS Fellow

Location/Room: Exhibit Hall: Booth 627

RAPS in the Exhibit HallRAPS Central

11:15 AM - 11:45 AM EST

Solutions Circle (B): Evolving Health Authority Thinking on Overall Survival for Oncology Trials

Location/Room: Exhibit Hall: Solutions Circle B

Facilitator: – Galderma

Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)

11:15 AM - 11:45 AM EST

Solutions Circle (C): How to Get the Most Out of Your RAPS Membership: Membership Benefits Discussion

Location/Room: Exhibit Hall: Solutions Circle C

Facilitator: – -

Repeat Solutions CircleBroad Interest & Skill Building

11:15 AM - 11:45 AM EST

Solutions Circle (A): Tips for Successful 10-day Conference Call with FDA

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – BD - Becton, Dickinson and Company

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

11:20 AM - 11:45 AM EST

Sponsored Presentation: Agents on the org chart: Redefining quality when AI operates within your QMS

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – Ketryx Corporation

Sponsor Presentation

Presented by

11:20 AM - 11:45 AM EST

Sponsored Presentation: From chaos to control: Mapping your RIM maturity journey

Location/Room: Exhibit Hall: Ignite! Theater Booth 925

Speaker: – Rimsys

Speaker: – Smith+Nephew

Sponsor Presentation

Presented By

11:20 AM - 11:45 AM EST

Sponsored Presentation: Lessons from a comparative analysis of old and new AI-infused regulatory processes

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – Weave

Sponsor Presentation

Presented By

11:30 AM - 12:30 PM EST

Speed Mentoring in Career Central, Exhibit Hall (Sign-Up Required)

Location/Room: Exhibit Hall: Booth 145

RAPS in the Exhibit HallCareer Central

11:30 AM - 1:00 PM EST

Networking Lunch in the Exhibit Hall

Location/Room: Exhibit Hall A, Level 2

Supported By

11:55 AM - 12:20 PM EST

Sponsored Presentation: Global supply chain compliance – UDI, EUDAMED, and other emerging use cases

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – USDM Life Sciences

Sponsor Presentation

Presented By

11:55 AM - 12:20 PM EST

Sponsored Presentation: Regulatory agility in action: Avoiding FDA CRLs with the strategic VDC approach

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – Cencora PharmaLex

Sponsor Presentation

Presented By

11:55 AM - 12:20 PM EST

Sponsored Presentation: View from the bridge: Navigating the uncertainty with your certification body

Location/Room: Exhibit Hall: Ignite! Theater Booth 925

Speaker: – BSI

Sponsor Presentation

Presented By

11:55 AM - 12:25 PM EST

Solutions Circle (A): Submission Gaps in Medical Devices in EU and How to Resolve

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – AKRA TEAM

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

11:55 AM - 12:25 PM EST

Solutions Circle (B): Regulatory Affairs: Belonging and Helping Others Belong

Location/Room: Exhibit Hall: Solutions Circle B

Facilitator: – NOMSA Regulatory and Writing LLC

Solutions Circle

11:55 AM - 12:25 PM EST

Solutions Circle (D): Sponsored Solutions Circle: Making the most of your clinical data matter in your FDA submissions – The dos and don’ts

Location/Room: Exhibit Hall: Solutions Circle D

Sponsor Facilitator: – NDA Partners

Sponsor Solutions Circle

Facilitated By

11:55 AM - 12:25 PM EST

Solutions Circle (C): State Licensing for Medical Device Companies: How Does it Apply to Me?

Location/Room: Exhibit Hall: Solutions Circle C

Facilitator: – QARA Solutions, LLC

Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

12:00 PM - 12:30 PM EST

RAPS Central Board Round Up: Practical, Ethical Use of AI in Regulatory

Location/Room: Exhibit Hall: Booth 627

RAPS in the Exhibit HallRAPS Central

12:00 PM - 12:45 PM EST

Career Central Stage: From Potential to Performance: How Regulatory Functions are Adopting AI

Location/Room: Exhibit Hall: Booth 145

Presenter: – RAPS

Presenter: – PwC

RAPS in the Exhibit HallCareer Central Stage

12:00 PM - 1:00 PM EST

RAPS Certification Lounge: Ask RAC & RCC Holders: Get your Certification Questions Answered

Location/Room: Exhibit Hall: Booth 300

RAPS in the Exhibit HallCertification Lounge

12:30 PM - 12:55 PM EST

Sponsored Presentation: Case study: How leading global pharma embraces AI to automate regulatory and medical documents of quality control

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – AlphaLife Sciences

Sponsor Presentation

Presented By

12:30 PM - 12:55 PM EST

Sponsored Presentation: Navigating the ripple effects of FDA downsizing: What it means for life sciences in 2025

Location/Room: Exhibit Hall: Ignite! Theater Booth 925

Speaker: – Network Partners Group (NPG)

Speaker: – Ascendis Pharma, Inc.

Speaker: – Network Partners Group

Sponsor Presentation

Presented By

12:30 PM - 12:55 PM EST

Sponsored Presentation: Speed without shortcuts: Navigating regulatory boundaries for AI applications in clinical trials

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – Parexel

Sponsor Presentation

Presented By

1:00 PM - 2:00 PM EST

A Lean System to Report Supply Interruptions and Discontinuations (Article 10a in EU, RoW)

Location/Room: 301

Session Leader: – AKRA TEAM

Presenter: – Axon Lawyers

Presenter: – mi-CE consultancy

Presenter: – Thermo Fisher Scientific

Devices (includes Medical Devices & In Vitro Diagnostics)

1:00 PM - 2:00 PM EST

Challenges in Precision Medicine Product Development

Location/Room: 304

Session Leader: – Pearl Pathways

Panelist: – Quantigen Biosciences

Panelist: – À propos Regulatory Consulting Services

Panelist: – Genentech

Panelist (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

1:00 PM - 2:00 PM EST

FDA-Regulated Research from the Lens of Institutional Review Boards: Addressing Common Pitfalls and Emerging Trends

Location/Room: 406

Presenter: – Indiana University

Broad Interest & Skill Building

1:00 PM - 2:00 PM EST

ICH Q1: 20 Years of Stability and a 2025 Transformation

Location/Room: 401

Presenter: – Parexel

Presenter (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

1:00 PM - 2:00 PM EST

Modeling the Future: Regulatory Perspectives on In Silico Tools for Medical Devices

Location/Room: 403

Session Leader: – TÜV SÜD

Presenter: – BD - Becton, Dickinson and Company

Presenter: – Ansys

Presenter (Remote): – Edwards LifeSciences

Devices (includes Medical Devices & In Vitro Diagnostics)

1:00 PM - 2:00 PM EST

Navigating the New Frontier: The Impact of Joint Clinical Assessments on Regulatory Affairs

Location/Room: 317

Presenter: – payer GmbH

Presenter (Remote): – European Medicines Agency

Presenter (Remote): – TLV

Pharmaceuticals (includes Biologics & Drugs)

1:00 PM - 2:00 PM EST

Translating the AI Regulatory Landscape to Quality Management Systems: EU MDR, ISO/IEC 42001, and Beyond

Location/Room: 315

Presenter: – Analog Devices

Presenter: – Hologic Inc

Devices (includes Medical Devices & In Vitro Diagnostics)

2:15 PM - 3:15 PM EST

Accelerating Cell Therapy Development: Challenges and Opportunities

Location/Room: 401

Presenter: – Kenai Therapeutics

Presenter: – -

Presenter (Remote): – U.S. Food and Drug Administration (FDA)

Pharmaceuticals (includes Biologics & Drugs)

2:15 PM - 3:15 PM EST

Accelerating China Market Access for Medical Devices: Regulatory Shifts, Clinical Leverage & Strategic Insights

Location/Room: 315

Presenter: – China Med Device, LLC

Presenter: – Intuitive Surgical, Inc.

Presenter: – Stryker Neurovascular International

Presenter: – Accuray

Moderator: – NOMSA Regulatory and Writing LLC

Devices (includes Medical Devices & In Vitro Diagnostics)

2:15 PM - 3:15 PM EST

Data Science and Management: Strength of Collaborations for Evidence Generation To Advance Medical Product Development

Location/Room: 304

Moderator: – Critical Path Institute

Presenter: – Critical Path Institute

Presenter: – ALS Therapy Development Institute

Presenter (Remote): – European Medicines Agency

Presenter (Remote): – U.S. Food and Drug Administration (FDA)

Pharmaceuticals (includes Biologics & Drugs)

2:15 PM - 3:15 PM EST

Decoding and Understanding Artificial Intelligence (AI) - EU AI implementation

Location/Room: 406

Presenter: – Siemens healthineers

Presenter: – Elekta

Devices (includes Medical Devices & In Vitro Diagnostics)

2:15 PM - 3:15 PM EST

Empowering Women's Health: Navigating Global Regulatory Challenges and Innovations

Location/Room: 403

Presenter: – RGM Life Sciences Consulting

Presenter: – European Medicines Agency

Presenter: – Meta

Presenter: – Haleon

Broad Interest & Skill Building

2:15 PM - 3:15 PM EST

FDA Forecast: What the FDA has Planned in 2026 for Pharmaceuticals and Biotechnology Products

Location/Room: 317

Panelist: – Accumulus Synergy

Panelist: – Citeline - The Pink Sheet

Panelist: – AgencyIQ

Panelist: – Esham Strategies LLC

Pharmaceuticals (includes Biologics & Drugs)

2:15 PM - 3:15 PM EST

International Regulators Forum

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Moderator: – AKRA TEAM

Speaker: – Malta Medicines Authority

Speaker: – RAPS BoD

Health Authority

2:15 PM - 3:15 PM EST

Latest Developments in PFAS

Location/Room: 301

Presenter: – DEKRA Certification

Presenter: – Industry Expert

Devices (includes Medical Devices & In Vitro Diagnostics)

3:15 PM - 3:45 PM EST

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall A, Level 2

Supported By

3:15 PM - 4:15 PM EST

Career Central Stage: Live LinkedIn Feedback Session

Location/Room: Exhibit Hall: Booth 145

Presenter: – Elemed

RAPS in the Exhibit HallCareer Central Stage

3:15 PM - 4:30 PM EST

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall A, Level 2

3:15 PM - 4:30 PM EST

Pawsitive Reinforcement

Location/Room: Exhibit Hall: Booth 1013

Supported by

3:15 PM - 4:30 PM EST

RAPS Certification Lounge: Exclusive Lounge Hours for RAC & RCC Holders

Location/Room: Exhibit Hall: Booth 300

RAPS in the Exhibit HallCertification Lounge

3:20 PM - 3:50 PM EST

Solutions Circle (C): Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry

Location/Room: Exhibit Hall: Solutions Circle C

Facilitator: – confinis ag

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

3:20 PM - 3:50 PM EST

Solutions Circle (A): Submission Gaps in Medical Devices in US and How to Resolve

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – RQM+

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

3:20 PM - 3:50 PM EST

Solutions Circle (D): Sponsored Solutions Circle: Prompt Smarter, Extract Faster: AI Techniques for Scientific Literature

Location/Room: Exhibit Hall: Solutions Circle D

Sponsor Facilitator: – Celegence

Sponsor Solutions Circle

Facilitated by

3:25 PM - 3:50 PM EST

Sponsored Presentation: Automating submission dossier with multi-modal AI

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – Certara

Sponsor Presentation

Presented By

3:25 PM - 3:50 PM EST

Sponsored Presentation: The future is now: Transforming regulatory processes through AI, ML, NLP, and RPAs

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – IQVIA

Sponsor Presentation

Presented By

3:25 PM - 3:50 PM EST

Sponsored Presentation: The future of regulatory affairs: How technology is shaping regulatory compliance

Location/Room: Exhibit Hall: Ignite! Theater Booth 925

Speaker: – RegDesk, Inc.

Sponsor Presentation

Presented By

3:45 PM - 4:15 PM EST

RAPS Central Board Round Up: Regulatory Leadership

Location/Room: Exhibit Hall: Booth 627

RAPS in the Exhibit HallRAPS Central

3:55 PM - 4:25 PM EST

Solutions Circle (A): Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – Bridging Consulting LLC

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

4:00 PM - 4:25 PM EST

Sponsored Presentation: Global regulatory strategy for precision medicine

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – Pearl Pathways, part of Versiti Clinical Trial Services

Sponsor Presentation

Presented By

4:30 PM - 5:30 PM EST

AI in Medical Devices: From Regulatory Frameworks to Global Market Readiness

Location/Room: 406

Presenter: – Analog Devices

Devices (includes Medical Devices & In Vitro Diagnostics)

4:30 PM - 5:30 PM EST

Conversations That Matter - Interactions With Health Authorities: Medical Devices and IVDs

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Moderator: – Ascendis Pharma, Inc.

Moderator: – Rezolute Bio

Panelist: – European Medicines Agency

Panelist: – TÜV SÜD

Panelist: – GMED Certification Division

Panelist: – TÜV SÜD

Panelist: – BSI

Panelist: – HPRA

Panelist: – RAPS BoD

Health Authority

4:30 PM - 5:30 PM EST

Enhancing the Collection, Communication, and Use of Patient Experience Data: Current Status and Next Steps

Location/Room: 317

Moderator: – PhRMA - Pharmaceutical Research & Manufacturers of America

Presenter: – Sanofi

Presenter: – Pfizer

Presenter: – U.S. Food and Drug Administration (FDA)

Presenter: – National Psoriasis Foundation

Pharmaceuticals (includes Biologics & Drugs)

4:30 PM - 5:30 PM EST

International Reliance and Work-Sharing Programs: Speeding up Access to Medicines

Location/Room: 401

Presenter: – KM Intel LLC

Presenter: – Genentech

Presenter: – European Medicines Agency

Presenter: – MHRA

Pharmaceuticals (includes Biologics & Drugs)

4:30 PM - 5:30 PM EST

Navigating the Future of mRNA Therapeutics-Exploration of Draft Guidelines, Industry Challenges, and Expert Insights

Location/Room: 403

Presenter: – APS Pharma Solutions, LLC

Presenter: – Arcturus Therapeutics

Presenter (Remote): – Medicines and Healthcare products Regulatory Agency (MHRA), UK

Pharmaceuticals (includes Biologics & Drugs)

4:30 PM - 5:30 PM EST

Rethinking Regulatory Strategy: De-risking Submissions and Addressing Payer Needs with Comprehensive Evidence Planning

Location/Room: 301

Presenter: – DuVal & Associates, P.A.

Devices (includes Medical Devices & In Vitro Diagnostics)

4:30 PM - 5:30 PM EST

Environmental and EcoDesign Requirements in Europe and Beyond

Location/Room: 315

Presenter: – Smith+Nephew

Presenter: – Axon Lawyers

Devices (includes Medical Devices & In Vitro Diagnostics)

4:30 PM - 5:30 PM EST

The Convergence of Regulatory and Politics: How the President and Congress Will Affect FDA Regulation

Location/Room: 304

Presenter: – AgencyIQ

Presenter: – AgencyIQ POLITICO

Presenter: – BGR Government Affairs

Broad Interest & Skill Building

5:45 PM - 7:15 PM EST

Honoring Excellence: RAPS 2025 Awards Celebration (Invitation Only)

Location/Room: Allegheny Overlook, Level 3

6:00 PM - 9:00 PM EST

Dine Arounds (Advanced Sign-up Required)

Location/Room: Offsite: Various Pittsburgh Restaurants

7:30 PM - 10:00 PM EST

SOLD OUT: Convergence Networking Party at Acrisure Stadium (Separate Ticketed Event)

Separate Ticket or Advanced Registration Required

Location/Room: Offsite: Acrisure Stadium

6:30 AM - 4:30 PM EST

Speaker Ready Room

Location/Room: 307

6:30 AM - 5:30 PM EST

Wellness Room

Location/Room: Near RAPS Store, Level 2

7:00 AM - 8:00 AM EST

Community Gathering & Morning Coffee

Location/Room: Regional Gallery, Level 3

7:00 AM - 3:00 PM EST

Registration Hours

Location/Room: Concourse A, Level 2

7:00 AM - 5:00 PM EST

RAPS Store & Hours

Location/Room: Concourse A, Registration Area

7:00 AM - 6:00 PM EST

Bag & Coat Check

Location/Room: Spirit of Pittsburgh Ballroom Lobby

7:00 AM - 6:00 PM EST

First Aid Office Hours

Location/Room: Near Room 301, Level 3

7:30 AM - 3:00 PM EST

Convergence App Support Hours

Location/Room: Concourse A, at Registration Desk

8:00 AM - 9:00 AM EST

Patient-Centered Health Award & Plenary Session: In Their Words: A Patient’s Journey Through Treatment and Trust

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Speaker: – Regulatory Affairs Professionals Society (RAPS)

Sponsor Speaker: – 3D Communications - ENTERPRISE

Moderator: – Pfizer

Panelist: – The Michael J. Fox Foundation for Parkinson's Research

9:15 AM - 10:30 AM EST

Building Resilient Drug Supply Chains: Advanced Strategies for Critical Shortage Prevention

Location/Room: 317

Session Leader: – USP - US Pharmacopeia

Presenter (Remote): – European Medicines Agency

Presenter: – AbbVie

Pharmaceuticals (includes Biologics & Drugs)

9:15 AM - 10:30 AM EST

CANCELLED: Health Authority Forum: CDER - FDA's Center for Drug Evaluation and Research

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Presenter (Remote): – U.S. Food and Drug Administration (FDA)

Health Authority

9:15 AM - 10:30 AM EST

Companion Diagnostics - Roles and Perspectives of the Therapeutic Product Manufacturer and Diagnostic Partner - Best Practices for Effective Collaboration

Location/Room: 401

Presenter: – GSK

Presenter: – Labcorp

Presenter: – Daiichi Sankyo, Inc.

Presenter (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

9:15 AM - 10:30 AM EST

EU Notified Body Forum: Tips and Tricks for Effective MDR/IVDR Implementation

Location/Room: 304

Moderator: – AKRA TEAM

Presenter: – TÜV SÜD

Presenter: – DNV Product Assurance

Presenter: – BSI

Presenter: – QServe Group

Devices (includes Medical Devices & In Vitro Diagnostics)

9:15 AM - 10:30 AM EST

Navigating the New US Regulatory Landscape for the MedTech Industry: Trends and Changes, Including MDUFA

Location/Room: 301

Moderator: – Veeva MedTech

Presenter: – Arnold & Porter

Presenter: – AgencyIQ POLITICO

Presenter: – Medtech Europe

Presenter: – Thermo Fisher Scientific

Devices (includes Medical Devices & In Vitro Diagnostics)

9:15 AM - 10:30 AM EST

Navigating Global Regulatory Pathways for Orphan Medical Devices

Location/Room: 315

Moderator: – AKRA TEAM

Presenter: – QServe Consultancy B.V.

Presenter: – BSI

Presenter: – European Medicines Agency

Presenter: – HPRA

Devices (includes Medical Devices & In Vitro Diagnostics)

9:15 AM - 10:30 AM EST

Preparing for the Future: Graduate Education and the Evolving Role of Regulatory Professionals

Location/Room: 406

Moderator: – Temple University Pharmacy School

Presenter: – Krieger School of Arts & Sciences Johns Hopkins University

Presenter: – University of Georgia, College of Pharmacy

Presenter: – University of Sydney

Broad Interest & Skill Building

9:15 AM - 10:30 AM EST

Reliance and Worksharing Procedures: Industry and Regulator Perspectives

Location/Room: 403

Presenter: – Regweb Consulting Services Inc.

Presenter: – QbD Group

Presenter: – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

10:30 AM - 11:00 AM EST

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall A, Level 2

10:30 AM - 1:00 PM EST

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall A, Level 2

10:30 AM - 1:00 PM EST

Pawsitive Reinforcement

Location/Room: Exhibit Hall: Booth 1013

Supported by

10:30 AM - 3:30 PM EST

Exhibit Hall Open Hours

Location/Room: Exhibit Hall A, Level 2

10:30 AM - 3:30 PM EST

RAPS Sales Lounge Hours

Location/Room: Exhibit Hall: Booth 1017

10:35 AM - 11:05 AM EST

Solutions Circle (C): Interested in Volunteering for RAPS Chapters or Local Networking Group? Unleashing the Power of Volunteering

Location/Room: Exhibit Hall: Solutions Circle C

Facilitator: – Kenai Therapeutics

Repeat Solutions CircleBroad Interest & Skill Building

10:35 AM - 11:05 AM EST

Solutions Circle (A): Regulatory Consulting-Ins and Outs

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – LuCore Regulatory Services LLC

Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)

10:35 AM - 11:05 AM EST

Solutions Circle (B): Quality Culture: How to Make Meaningful Impact as an Early-Career Professional

Location/Room: Exhibit Hall: Solutions Circle B

Facilitator: – Analog Devices

Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

10:35 AM - 11:05 AM EST

Solutions Circle (D): Sponsored Solutions Circle: What NOT TO DO in RIM Implementations

Location/Room: Exhibit Hall: Solutions Circle D

Sponsor Facilitator: – Rimsys

Sponsor Solutions Circle

Facilitated by

10:45 AM - 11:00 AM EST

Career Central Stage Student Capstone Presentation: Enhancing Informed Consent: A Study on Novel Barriers to Implementation

Location/Room: Exhibit Hall: Booth 145

Graduate Student Presenter: – Artivion

RAPS in the Exhibit HallCareer Central StageStudent Focus

10:45 AM - 11:10 AM EST

Sponsored Presentation: A regulatory affairs year to remember: Leveraging learnings to move forward in 2026

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – 3D Communications - ENTERPRISE

Speaker: – 3D Communications

Speaker: – Ireland Strategies, LLC

Speaker: – Leavitt Partners

Speaker: – Pink Sheet

Sponsor Presentation

Presented By

10:45 AM - 11:10 AM EST

Sponsored Presentation: Ensuring compliance across the distribution chain: A deep dive into economic operators’ roles

Location/Room: Exhibit Hall: Ignite! Theater Booth 925

Speaker: – MedEnvoy Global

Sponsor Presentation

Presented By

10:45 AM - 11:10 AM EST

Sponsored Presentation: No hype, just help: AI tools that support your daily regulatory workflow

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – NyquistAI

Sponsor Presentation

Presented By

11:00 AM - 11:30 AM EST

RAPS Central Board Round Up: Is Quality Part of your Organization’s DNA?

Location/Room: Exhibit Hall: Booth 627

RAPS in the Exhibit HallRAPS Central

11:00 AM - 12:00 PM EST

RAPS Certification Lounge: Ask RAC & RCC Holders: Get your Certification Questions Answered

Location/Room: Exhibit Hall: Booth 300

RAPS in the Exhibit HallCertification Lounge

11:15 AM - 11:30 AM EST

Career Central Stage Student Capstone Presentation: Implementing E-Labeling in Pharma and Medical Devices: A Step-by-Step Guide

Location/Room: Exhibit Hall: Booth 145

Graduate Student Presenter: – Northeastern University

RAPS in the Exhibit HallCareer Central StageStudent Focus

11:15 AM - 11:45 AM EST

Solutions Circle (B): Evolving Health Authority thinking on Overall Survival for Oncology Trials

Location/Room: Exhibit Hall: Solutions Circle B

Facilitator: – Galderma

Repeat Solutions CirclePharmaceuticals (includes Biologics & Drugs)

11:15 AM - 11:45 AM EST

Solutions Circle (C): How to Get the Most Out of Your RAPS Membership: Membership Benefits Discussion

Location/Room: Exhibit Hall: Solutions Circle C

Facilitator: – -

Repeat Solutions CircleBroad Interest & Skill Building

11:15 AM - 11:45 AM EST

Solutions Circle (A): Tips for successful 10-day Conference Call with FDA

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – BD - Becton, Dickinson and Company

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

11:20 AM - 11:45 AM EST

Sponsored Presentation: Global regulatory strategy: Change management

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – Emergo by UL

Sponsor Presentation

Presented By

11:20 AM - 11:45 AM EST

Sponsored Presentation: Revisiting EU MDR: Stakeholder Voices, Regulatory Shifts, and Notified Body Improvements

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – Intertek Medical Notified Body AB

Sponsor Presentation

Presented By

11:20 AM - 11:45 AM EST

Sponsored Presentation: RI impact: How AI and systematic reviews deliver measurable and actionable regulatory intelligence

Location/Room: Exhibit Hall: Ignite! Theater Booth 925

Speaker: – MedBoard

Sponsor Presentation

Presented By

11:30 AM - 12:30 PM EST

Speed Mentoring in Career Central, Exhibit Hall (Sign-Up Required)

Location/Room: Exhibit Hall: Booth 145

RAPS in the Exhibit HallCareer Central

11:30 AM - 12:30 PM EST

Let's talk Writing for RAPS: A ‘how-to’ guide for book and journal content

Location/Room: 301

Presenter: – Regulatory Affairs Professionals Society

Presenter: – RAPS

11:30 AM - 1:00 PM EST

Networking Lunch in the Exhibit Hall

Location/Room: Exhibit Hall A, Level 2

11:55 AM - 12:20 PM EST

Sponsored Presentation: Convergence and reliance at a crossroads: Accelerating submissions and addressing priorities in post approval changes

Location/Room: Exhibit Hall: Ignite! Theater Booth 925

Speaker: – Indegene, Inc.

Speaker: – Indegene Inc.

Sponsor Presentation

Presented By

11:55 AM - 12:20 PM EST

Sponsored Presentation: Implementing flexibility and efficiency in labeling change management

Location/Room: Exhibit Hall: Discover! Theater Booth 425

Speaker: – Bayer

Sponsor Presentation

Presented By

11:55 AM - 12:20 PM EST

Sponsored Presentation: The MIT AI Report: Why Most AI Implementations Fail—Lessons from AI Case Studies in Regulatory Affairs

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – Essenvia

Speaker: – Terumo Medical Corp.

Sponsor Presentation

Presented by

11:55 AM - 12:25 PM EST

Solutions Circle (A): Submission Gaps in Medical Devices in EU and How to Resolve

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – AKRA TEAM

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

11:55 AM - 12:25 PM EST

Solutions Circle (B): Enhancing Understanding of Biologic Variability Through Representation in Clinical Trials

Location/Room: Exhibit Hall: Solutions Circle B

Facilitator: – EMD Serono

Solutions Circle: Continuing the ConversationPharmaceuticals (includes Biologics & Drugs)

12:00 PM - 12:30 PM EST

Career Central Stage: Introducing a New Credential: How the FRA Empowers New Professionals

Location/Room: Exhibit Hall: Booth 145

Presenter: – RAPS

Presenter: – Regulatory Affairs Professional Society (RAPS)

RAPS in the Exhibit HallCareer Central Stage

12:00 PM - 12:30 PM EST

RAPS Central Board Round Up: Ask Me Anything!

Location/Room: Exhibit Hall: Booth 627

RAPS in the Exhibit HallRAPS Central

1:00 PM - 2:00 PM EST

A Case Study on Health Equity Through the Lens of Pulse Oximetry

Location/Room: 301

Presenter: – Medtronic

Moderator: – Veeva MedTech

Devices (includes Medical Devices & In Vitro Diagnostics)

1:00 PM - 2:00 PM EST

Conversations That Matter - Interactions With Health Authorities: Drugs, Biologics and Combination Products

Location/Room: Spirit of Pittsburgh Ballroom, Level 3

Moderator: – Ascendis Pharma, Inc.

Moderator: – Rezolute Bio

Panelist: – European Medicines Agency

Panelist: – Malta Medicines Authority

Panelist: – RAPS BoD

Presenter: – khhconsult

Health Authority

1:00 PM - 2:00 PM EST

Engineering Safety and Effectiveness for Regulatory Excellence in Drug-Device Combination Products

Location/Room: 317

Presenter: – GessNet

Presenter: – AbbVie

Presenter: – BD

Presenter: – Lilly

Moderator: – medtechnik

Pharmaceuticals (includes Biologics & Drugs)

1:00 PM - 2:00 PM EST

Enhancing Charisma and Influence: Non-Verbal and Digital Body Language for Regulatory Professionals

Location/Room: 403

Presenter: – AstraZeneca

Broad Interest & Skill Building

1:00 PM - 2:00 PM EST

Global Oncology Drug Advisory Mechanisms: Insights from FDA’s ODAC and International Counterparts

Location/Room: 304

Presenter: – Summit Therapeutics

Presenter: – Apath Nexus

Presenter: – AgencyIQ

Presenter (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

1:00 PM - 2:00 PM EST

Optimizing Strategies to Support Implementation of the Global Post-Approval Changes in the Product Life Cycle

Location/Room: 401

Presenter: – Mirum Pharmaceuticals

Presenter (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

1:00 PM - 2:00 PM EST

Accelerating Postmarket Innovation with Predetermined Change Control Plans (PCCPs): AI/ML and Beyond

Location/Room: 315

Moderator: – Bridging Consulting LLC

Panelist: – Hogan Lovells

Panelist: – MCRA, an IQVIA Company

Panelist: – Medtronic

Panelist: – Beacon Biosignals

Devices (includes Medical Devices & In Vitro Diagnostics)

1:00 PM - 2:00 PM EST

Structured Dialogues: 10 Effective Topics to Engage With Your Notified Body

Location/Room: 406

Moderator: – QServe Group

Moderator: – TÜV SÜD

Panelist: – BSI

Panelist: – TÜV SÜD Product Service GmbH

Panelist: – QServe Consultancy B.V.

Panelist: – Elekta

Devices (includes Medical Devices & In Vitro Diagnostics)

2:00 PM - 2:25 PM EST

Career Central Student Capstone Poster Display: Digital Healthcare Platforms and Artificial Intelligence in Global Regulatory Compliance for Medical Devices

Location/Room: Exhibit Hall: Booth 145

Graduate Student Presenter: – University of Georgia

RAPS in the Exhibit HallCareer CentralStudent Focus

2:00 PM - 2:25 PM EST

Career Central Student Capstone Poster Display: Is More Technology Always Better? Participant Burden Considerations in Clinical Trials

Location/Room: Exhibit Hall: Booth 145

Graduate Student Presenter: – Accumulus Synergy

RAPS in the Exhibit HallCareer CentralStudent Focus

2:00 PM - 2:30 PM EST

Refreshment Break in the Exhibit Hall

Location/Room: Exhibit Hall A, Level 2

2:00 PM - 3:15 PM EST

Exclusive Exhibit Hall Hours: Networking & Presentations

Location/Room: Exhibit Hall A, Level 2

2:00 PM - 3:15 PM EST

Pawsitive Reinforcement

Location/Room: Exhibit Hall: Booth 1013

Supported by

2:00 PM - 3:15 PM EST

RAPS Certification Lounge: Exclusive Lounge Hours for RAC & RCC Holders

Location/Room: Exhibit Hall: Booth 300

RAPS in the Exhibit HallCertification Lounge

2:00 PM - 3:15 PM EST

RAPS Chapter/LNG Meet & Greets in Career Central

Location/Room: Exhibit Hall: Booth 145

RAPS in the Exhibit HallCareer Central

2:05 PM - 2:35 PM EST

Solutions Circle (C): Early Innovation: Navigating the Tech Transfer Journey from Academia to Industry

Location/Room: Exhibit Hall: Solutions Circle C

Facilitator: – confinis ag

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

2:05 PM - 2:35 PM EST

Solutions Circle (A): Submission Gaps in Medical Devices in US and How to Resolve

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – RQM+

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

2:10 PM - 2:35 PM EST

Sponsored Presentation: Clinical evaluation reports: Notified Body expectations

Location/Room: Exhibit Hall: Spark! Theater Booth 637

Speaker: – SGS North America

Sponsor Presentation

Presented by

2:30 PM - 3:00 PM EST

RAPS Central Board Round Up: Ethical Challenges in Regulatory

Location/Room: Exhibit Hall: Booth 627

RAPS in the Exhibit HallRAPS Central

2:30 PM - 3:15 PM EST

Career Central Stage: Convergence Is Over - Now What? How to Create Lasting Professional Relationships

Location/Room: Exhibit Hall: Booth 145

Presenter: – Compliance-Alliance, LLC

Presenter:

RAPS in the Exhibit HallCareer Central Stage

2:40 PM - 3:10 PM EST

Solutions Circle (A): Navigating Novel Risks in AI/ML/LLM-Enabled Medical Devices: Regulatory and Lifecycle Risk Management Strategies

Location/Room: Exhibit Hall: Solutions Circle A

Facilitator: – Bridging Consulting LLC

Repeat Solutions CircleDevices (includes Medical Devices & In Vitro Diagnostics)

2:40 PM - 3:10 PM EST

Solutions Circle (C): The Convergence of Regulatory and Politics: How the President and Congress will Affect FDA Regulation

Location/Room: Exhibit Hall: Solutions Circle C

Facilitator: – AgencyIQ POLITICO

Solutions Circle: Continuing the ConversationBroad Interest & Skill Building

3:15 PM - 4:15 PM EST

Accelerating Regulatory Discussion on Digital Health Devices

Location/Room: 317

Session Leader: – J&J MedTech

Presenter: – MCRA, an IQVIA Company

Presenter: – Johnson & Johnson MedTech | Heart Recovery

Presenter: – Accenture

Presenter (Remote): – U.S. Food and Drug Administration (FDA)

Devices (includes Medical Devices & In Vitro Diagnostics)

3:15 PM - 4:15 PM EST

Can GenAI Help Regulatory Teams Scale Up Their Operations? Pitfalls and Best Practices

Location/Room: 301

Session Leader: – Veeva MedTech

Presenter: – Elemed

Presenter: – Smith+Nephew

Presenter: – Scarlet

Broad Interest & Skill Building

3:15 PM - 4:15 PM EST

China Drug Regulatory Pathways: 2025 Current Landscape & Global Integration Perspectives

Location/Room: 406

Presenter: – Cisema

Presenter: – Amgen

Presenter: – OBI Pharma

Pharmaceuticals (includes Biologics & Drugs)

3:15 PM - 4:15 PM EST

Cybersecurity Regulations and Policy: FDA and Beyond

Location/Room: 315

Presenter: – MedSec LLC

Presenter: – MedSec

Devices (includes Medical Devices & In Vitro Diagnostics)

3:15 PM - 4:15 PM EST

Mastering EUDAMED: Current Framework and Implementation Strategies

Location/Room: 403

Presenter: – Thermo Fisher Scientific

Presenter: – EirMed Ltd

Presenter: – Obelis

Devices (includes Medical Devices & In Vitro Diagnostics)

3:15 PM - 4:15 PM EST

Is it Time for a New Patient Experience Data Section in Product Labeling?

Location/Room: 304

Session Leader: – Sanofi

Panelist: – European Medicines Agency

Panelist: – EMD Serono/ Merck KGaA, Darmstadt, Germany

Panelist: – Gaucher Community Alliance

Panelist: – U.S. Food and Drug Administration (FDA)

Pharmaceuticals (includes Biologics & Drugs)

3:15 PM - 4:15 PM EST

Recent Developments in Nitrosamines

Location/Room: 401

Presenter: – Genentech

Presenter (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

4:30 PM - 5:30 PM EST

Conformity Assessment of Class D Devices & EURL Implementation: Progress and Challenges One Year On

Location/Room: 304

Presenter: – TÜV SÜD

Presenter: – BSI BV

Presenter: – GMED

Presenter (Remote): – RISE

Presenter (Remote): – European Commission

Devices (includes Medical Devices & In Vitro Diagnostics)

4:30 PM - 5:30 PM EST

Emerging Regulatory Trends, Pre-Marketing Submissions

Location/Room: 301

Session Leader: – AKRA TEAM

Presenter: – Veeva MedTech

Presenter: – Trinity College, Dublin

Presenter: – BSI

Broad Interest & Skill Building

4:30 PM - 5:30 PM EST

Expanding Global Biosimilar Access: Converging Regulatory Approaches with Analytical Insights

Location/Room: 401

Session Leader: – United States Pharmacopeia

Presenter (Remote): – European Medicines Agency

Panelist (Remote): – U.S. Food and Drug Administration (FDA)

Presenter: – Agência Nacional de Vigilância Sanitária (ANVISA)

Pharmaceuticals (includes Biologics & Drugs)

4:30 PM - 5:30 PM EST

Pediatric Regulatory Strategies and Trends in the EU and US

Location/Room: 403

Session Leader: – Ipsen

Presenter: – INVENTIVA

Presenter: – khhconsult

Presenter (Remote): – European Medicines Agency

Pharmaceuticals (includes Biologics & Drugs)

4:30 PM - 5:30 PM EST

QSR to QMSR Shift: Best Practices, Pitfalls & Compliance Strategies

Location/Room: 315

Presenter: – SCIEX

Presenter: – NA

Devices (includes Medical Devices & In Vitro Diagnostics)

4:30 PM - 5:30 PM EST

Scaling the Pond: Routes to Market in the UK and Switzerland

Location/Room: 406

Moderator: – Thermo Fisher Scientific

Presenter: – TÜV SÜD

Presenter: – BSI

Presenter: – Medicines and Healthcare products Regulatory Agency (MHRA)

Presenter: – ISS AG, Integrated Scientific Services

Devices (includes Medical Devices & In Vitro Diagnostics)

4:30 PM - 5:30 PM EST

Transforming Medication Access: Using Technology and FDA’s New NDA Pathway Empowers Patient Options

Location/Room: 317

Presenter: – Klick

Presenter: – Klick Consulting

Presenter (Remote): – U.S. Food and Drug Administration (FDA)

Pharmaceuticals (includes Biologics & Drugs)

6:30 PM - 9:30 PM EST

RAPS Convergence 2025 Closing Party Celebration at Heinz History Center

Location/Room: Offsite: Heinz History Center

Supported by