Full Schedule

6:30 AM – 5:00 PM PDT

Speaker Ready Room

6:30 AM – 5:30 PM PDT

Registration Hours

6:30 AM – 5:30 PM PDT

Wellness Room

7:00 AM – 8:00 AM PDT

Community Gathering & Morning Coffee

7:00 AM – 6:00 PM PDT

First Aid Office & Hours

7:30 AM – 5:30 PM PDT

Event App Support Desk Hours

7:30 AM – 6:00 PM PDT

RAPS Store Hours

8:00 AM – 8:15 AM PDT

RAPS Convergence 2024 Plenary Session: Morning Welcome and Patient-Centered Health Award Presentation

Presenter: – Alexion, AstraZeneca Rare Disease

Presenter: – Regulatory Affairs Professionals Society (RAPS)

Award Recipient: – Critical Path Institute

Networking Opportunity

8:00 AM – 5:00 PM PDT

RAPS Wellness Challenge

Networking Opportunity

8:15 AM – 9:00 AM PDT

RAPS Convergence 2024 Plenary Session: Challenges in Developing Medical Technologies for Unmet Medical Needs

Moderator: – Ipsen

Panelist: – Critical Path Institute

Panelist: – khhconsulting

Panelist: – RQM+

Panelist: – KCNT1 Epilepsy Foundation

Networking Opportunity

9:15 AM – 10:30 AM PDT

Addressing Medicines Shortages in EU: Prevent, Mitigate, and Ensure Visibility

Presenter: – Clarivate

Presenter (Remote): – EMA

Presenter (Remote): – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

9:15 AM – 10:30 AM PDT

Future State of Europe

Moderator: – TÜV SÜD Medical Health Services

Moderator: – Qserve Group

Presenter: – TÜV SÜD Product Services

Presenter: – Elekta

Presenter (Remote): – European Commission

Devices (includes Medical Devices and In Vitro Diagnostics)

9:15 AM – 10:30 AM PDT

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

Presenter: – European Medicines Agency

Presenter: – Austrian Medicines and Medical Devices Agency

Presenter: – European Medicines Agency

Presenter (Remote): – European Medicines Agency

Health Authority Session

9:15 AM – 10:30 AM PDT

Increasing Consumer/Patient Access, Engagement and Health Equity: Innovation Leveraging FDA Proposed/New ACNU NDA Regulatory Pathway

Session Leader: – Klick Health

Presenter: – Haleon

Presenter: – FDA

Biopharmaceuticals (includes Biologics and Drugs)

9:15 AM – 10:30 AM PDT

Progress Towards Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs

Session Leader: – Alexion, AstraZeneca Rare Disease

Presenter: – Regulatory Affairs Professionals Society (RAPS)

Presenter: – Network Partners Group (NPG)

Presenter: – University of Georgia

Presenter: – Elemed

Presenter: – Becton, Dickinson & Company (BD)

Skill Building

9:15 AM – 10:30 AM PDT

Standardization of Clinical Study Design

Presenter: – AKRA TEAM

Presenter: – DNV Product Assurance AS

Presenter (Remote): – MD-CLINICALS SA

Presenter (Remote):

Devices (includes Medical Devices and In Vitro Diagnostics)

9:15 AM – 10:30 AM PDT

Using Innovative Regulatory Strategies to Streamline Drug Development – Platform Trials, Model Informed Drug Development, and Real World Evidence

Session Leader: – Fairmount Funds Management

Presenter: – Amgen

Presenter (Remote): – EMA

Presenter (Remote): – FDA / CDER / OTS / OCP

Biopharmaceuticals (includes Biologics and Drugs)

10:00 AM – 4:30 PM PDT

Career Central Hours (Exhibit Hall: Booth 349)

Exhibit Hall

Supported By

10:30 AM – 11:00 AM PDT

Refreshment Break in the Exhibit Hall

Networking OpportunityExhibit Hall

Supported by

10:30 AM – 1:00 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Networking OpportunityExhibit Hall

10:30 AM – 4:30 PM PDT

Certification Lounge Hours (Exhibit Hall: Booth 225)

Exhibit Hall

10:30 AM – 4:30 PM PDT

Exhibit Hall Open

Networking OpportunityExhibit Hall

10:30 AM – 4:30 PM PDT

Headshot Lounge Hours (Exhibit Hall: Booth 1049)

Exhibit Hall

Supported by

10:30 AM – 4:30 PM PDT

RAPS Central Hours (Exhibit Hall: Booth 813)

Exhibit Hall

10:30 AM – 4:30 PM PDT

Regulatory Cares Community Giveback Booth Hours (Exhibit Hall: Booth 425)

Exhibit Hall

10:30 AM – 4:30 PM PDT

Student Capstone Poster Display: Benchmarking drug regulatory systems for capacity building in registration and marketing authorization: a systematic review

Graduate Student Presenter:

Student Focus

10:30 AM – 4:30 PM PDT

Student Capstone Poster Display: Comparative Analysis of Orphan Drug Legislation: USA, EU, and India Perspectives

Graduate Student Presenter:

Student Focus

10:30 AM – 4:30 PM PDT

Student Capstone Poster Display: E-Labeling Essentials: Adapting Processes to Meet Evolving Global Standards and Regulations

Graduate Student Presenter: – NORTHEASTERN UNIVERSITY

Student Focus

10:30 AM – 4:30 PM PDT

Student Capstone Poster Display: Opportunities of Patient-Centered Approaches in Clinical Study Design

Graduate Student Presenter:

Student Focus

10:35 AM – 11:05 AM PDT

Solution Circle (A): How to Prepare for a Successful FDA Q-sub

Facilitator: – Abbott

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

10:35 AM – 11:05 AM PDT

Solution Circle (B): Is this AI/ML Software Application a Medical device? Applying FDA Guidance Documents and On-Line Resources

Facilitator: – Beckman Coulter

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

10:35 AM – 11:05 AM PDT

Solution Circle (C): Leveraging Dual RAC Certification to become an Expert in Enhancing the Success of Combination Product Development.

Proficiency: Foundational/ Operational/ Novice

Facilitator: – Veristat Inc

Exhibit Hall: Solutions CircleOther

10:35 AM – 11:05 AM PDT

Solution Circle (D): Maximizing the Potential of Meetings with the FDA

Facilitator: – HMC-regulation; Dr. Hagit Marchaim RA and Drug Development Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

10:45 AM – 11:10 AM PDT

Sponsored Presentation: Get Your Products to Market and Keep Them There: How to Leverage a Fit-For-Purpose AI-Enabled Platform to Accelerate Time-To-Market

Speaker: – Dr.Evidence

Speaker: – PepGen Inc.

Presented by

10:45 AM – 11:10 AM PDT

Sponsored Presentation: Maintaining Post-Market Clinical Data Efficiently With Technology (Automation/AI) for Sustainable MDR and IVDR Compliance

Speaker: – Celegence

Presented by

10:45 AM – 11:10 AM PDT

Sponsored Presentation: Revolutionizing Life Science Recalls

Speaker:

Presented by

10:45 AM – 11:15 AM PDT

RAPS BOD Roundtable: Emerging Regulatory Trends

Guest Speaker: – NDA Partners

Guest Speaker:

Guest Speaker: – Salditt Regulatory Consulting LLC

Guest Speaker: – RAPS BoD

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

11:00 AM – 11:30 AM PDT

Career Central Stage: Get Certified in Regulatory Affairs: Get Your RAC!

Presenter: – Johnson & Johnson

Presenter: – Powers Regulatory Consulting

Presenter: – Boston Scientific

Exhibit Hall: Career Central

Supported By

11:10 AM – 11:40 AM PDT

Solution Circle (A): Evaluating the Quality of Real-World Evidence Used to Support Regulatory Decision-Making for Medical Devices

Facilitator: – Johnson and Johnson

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

11:10 AM – 11:40 AM PDT

Solution Circle (B): Strategies on Tackling Clinical Data Gaps Between Different Designs of Medical Devices (B):

Facilitator: – Akra Team Inc.

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

11:10 AM – 11:40 AM PDT

Solution Circle (C): The Right Balance Between Business, Science, and Regulation in Managing Supply Chains

Facilitator: – Biohaven Pharmaceuticals

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

11:15 AM – 11:50 AM PDT

Sponsored Presentation: A Breakthrough Approach to PMCF; Reducing Time, Cost and Risk

Speaker: – 3Aware

Presented by

11:15 AM – 11:50 AM PDT

Sponsored Presentation: Case Study: Harnessing the Power of AI to Streamline Regulatory Processes

Speaker: – Weave

Presented by

11:15 AM – 11:50 AM PDT

Sponsored Presentation: Optimizing Health Authority Interaction Outcomes Using an Integrated Strategy and Multidisciplinary Global Regulatory and Product Development Team

Speaker: – Allucent

Presented by

11:30 AM – 12:30 PM PDT

RAPS “Speed Mentoring” in Career Central

Exhibit Hall: Career CentralNetworking Opportunity

Supported By

11:30 AM – 1:00 PM PDT

Networking Lunch in the Exhibit Hall

Networking OpportunityExhibit Hall

11:45 AM – 12:15 PM PDT

Career Central Stage: RAPS 2024 Global Compensation and Scope of Practice Report: Learn How You Measure Up

Presenter: – RAPS

Exhibit Hall: Career Central

Supported By

11:45 AM – 12:15 PM PDT

Solution Circle (A): Career Pathways in Regulatory Affairs

Facilitator: – KPMG

Exhibit Hall: Solutions CircleOther

11:45 AM – 12:15 PM PDT

Solution Circle (B): Establishing a Regulatory Talent Pipeline Strategy for Industry 4.0

Facilitator: – Medtronic

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

11:45 AM – 12:15 PM PDT

Solution Circle (C): Phase and Product Appropriate Regulatory Strategies in Impurity Characterizations and Controls

Facilitator: – El Vista Consulting LLC

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

11:45 AM – 12:15 PM PDT

Solution Circle (D): Post-Market 510(k) and De Novo Change Management: Cinderella Strategies for Keeping Your House in Order

Facilitator: – DuVal & Associates, P.A.

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

11:55 AM – 12:20 PM PDT

Sponsored Presentation: Best Practices in the Use of PMCF Surveys

Speaker: – Purdie Pascoe

Presented by

11:55 AM – 12:20 PM PDT

Sponsored Presentation: Commercializing a Medical Device: Where to Start?

Speaker: – Biologics Consulting Group, Inc.

Presented by

11:55 AM – 12:20 PM PDT

Sponsored Presentation: The Regulatory Landscape of FDA-Approved Medicinal Products for Rare Pediatric Diseases

Speaker: – Parexel

Presented by

12:20 PM – 12:50 PM PDT

Solution Circle (A): LDT, RUO, IVD: What Regulatory Status for Tests Used in European Clinical Trial?

Facilitator: – Namsa

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

12:20 PM – 12:50 PM PDT

Solution Circle (B): Orphan Drug Approval FDA / EMA - What are the Benefits? What is the Process?

Facilitator: – Team Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

12:25 PM – 12:50 PM PDT

Sponsored Presentation: Digital Transformation and the Future of RA Teams

Speaker: – Rimsys

Speaker: – KPMG US

Presented by

12:25 PM – 12:50 PM PDT

Sponsored Presentation: From Plan to Practice: Continuous AI/ML Device Validation Per Your PCCP

Speaker: – Ketryx Corporation

Presented by

12:25 PM – 12:50 PM PDT

Sponsored Presentation: Leveraging Technology and Smart Templates to Optimize EU MDR Clinical Evaluation and Post-Market Surveillance Documentation

Speaker: – RQM+

Presented by

12:30 PM – 1:00 PM PDT

Meet the Authors: Fundamentals of Medical Device Regulations: A Global Perspective

Moderator: – RAPS

Presenter: – Mycovia Pharmaceuticals, Inc.

Presenter: – Canon Medical Informatics, Inc.

12:30 PM – 1:00 PM PDT

New! RAPS Mentoring Program

Networking OpportunityExhibit Hall: RAPS Central

1:00 PM – 2:00 PM PDT

CDER’s Product Quality Review of Biologics & Biosimilars: Common Findings, Review Issues and Post-Marketing Recommendations

Presenter: – Visterra, Inc

Presenter (Remote): – FDA / CDER / OPQ / OPQAIII

Biopharmaceuticals (includes Biologics and Drugs)

1:00 PM – 2:00 PM PDT

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

Moderator: – Alexion, AstraZeneca Rare Disease

Panelist: – US Food and Drug Administration

Panelist: – BSI

Panelist: – European Medicines Agency

Panelist: – TÜV SÜD Medical Health Services

Panelist: – Austrian Medicines and Medical Devices Agency

Health Authority Session

1:00 PM – 2:00 PM PDT

Digital Labeling and eIFU Enhance Customer Experience, Facilitate Compliance, and Improve Operational Efficiencies and Agility

Presenter: – Edwards Lifesciences Sarl

Presenter: – Johnson & Johnson Medtech

Presenter (Remote): – European Medicines Agency

Devices (includes Medical Devices and In Vitro Diagnostics)

1:00 PM – 2:00 PM PDT

Examining Methods to Ensure Data Quality and Privacy Considerations for AI-Enabled Medical Devices

Session Leader: – Innomar Strategies Inc.

Presenter: – be-on-Quality GmbH

Devices (includes Medical Devices and In Vitro Diagnostics)

1:00 PM – 2:00 PM PDT

FDA Forecast: What the FDA has Planned in 2025 for Pharmaceuticals and Biotechnology Products

Presenter: – AgencyIQ

Presenter: – Pink Sheet

Presenter: – PwC

Moderator: – Accumulus Synergy

Biopharmaceuticals (includes Biologics and Drugs)

1:00 PM – 2:00 PM PDT

Regulatory Challenges in New Drug Approval in India and the Way Forward

Presenter: – REGULATORY WISDOM

Moderator: – Genentech and Roche

Biopharmaceuticals (includes Biologics and Drugs)

1:00 PM – 2:00 PM PDT

The Importance of Data Standardization in Clinical Trials; An Update From an MDIC Supported Project

Session Leader: – Veeva Systems

Presenter: – MDIC

Presenter: – Roche

Devices (includes Medical Devices and In Vitro Diagnostics)

2:15 PM – 3:15 PM PDT

2024 LDT Regulatory Shifts: Understanding Impacts & Strategic Adaptation for Stakeholders

Presenter: – Summit Therapeutics

Presenter: – Blackhawk Genomics

Presenter: – Siemens Healthineers

Devices (includes Medical Devices and In Vitro Diagnostics)

2:15 PM – 3:15 PM PDT

Accelerating Novel Platforms into the Clinic: Early Experiences with FDA’s Advanced Manufacturing Technology (AMT) Designation and Global Perspectives

Presenter: – Cytiva

Presenter: – European Medicines Agency

Presenter (Remote): – CBER/FDA

Biopharmaceuticals (includes Biologics and Drugs)

2:15 PM – 3:15 PM PDT

Clinical Trials in Pregnancy and Lactation: Time for a Paradigm Shift?

Session Leader: – UCB

Presenter: – University of North Carolina at Chapel Hill

Presenter: – FDA Center for Drug Evaluation and Research

Presenter (Remote): – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

2:15 PM – 3:15 PM PDT

Health Authority Forum: CDRH - FDA's Center for Devices and Radiological Health

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

Presenter (Remote): – FDA CDRH

Presenter (Remote): – US Food and Drug Administration

Presenter (Remote):

Panel Facilitator: – Thermo Fisher Scientific

Health Authority Session

2:15 PM – 3:15 PM PDT

Monitoring AI Devices

Presenter: – MDIC

Presenter: – Google

Presenter: – Medtronic

Devices (includes Medical Devices and In Vitro Diagnostics)

2:15 PM – 3:15 PM PDT

Nurturing a Regulatory Excellence Ecosystem: Cultivating the Culture of Regulatory Affairs in Early Career Professionals

Moderator: – Veeva Systems

Presenter: – Northeastern University

Presenter: – Alphatec Spine

Presenter: – Bracco Medical Technologies

Skill Building

2:15 PM – 3:15 PM PDT

Quantifying Patient Burden in Protocol Design to Reduce Complexity and Drive Patient-Centricity

Moderator: – BioMarin Pharmaceutical, Inc.

Presenter: – PricewaterhouseCoopers (PwC)

Presenter: – FDA / CDER

Biopharmaceuticals (includes Biologics and Drugs)

2:15 PM – 3:15 PM PDT

UKCA & Market Developments

Moderator: – Qserve Group

Presenter: – TÜV SÜD

Presenter: – BSI

Presenter: – MHRA

Presenter: – ABHI

Devices (includes Medical Devices and In Vitro Diagnostics)

3:00 PM – 3:30 PM PDT

RAPS Fellows: How to Maximize the Application Process

Exhibit Hall: RAPS CentralNetworking Opportunity

3:00 PM – 3:30 PM PDT

Refreshment Break in the Exhibit Hall

Networking OpportunityExhibit Hall

Supported By

3:15 PM – 4:30 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Networking OpportunityExhibit Hall

3:30 PM – 3:55 PM PDT

Sponsored Presentation: EU Conformity Assessment of Uncommon Product Configurations

Speaker: – SGS North America Inc.

Presented by

3:30 PM – 3:55 PM PDT

Sponsored Presentation: Meeting EUDAMED Product Syndication and Vigilance Requirements

Speaker: – USDM Life Sciences

Speaker: – Bayard GmbH

Presented by

3:30 PM – 3:55 PM PDT

Sponsored Presentation: Navigating and Managing the Global Regulatory Landscape: Strategic Approaches for Success

Speaker: – Emergo by UL

Presented by

3:30 PM – 4:00 PM PDT

Career Central Stage: Get Your Regulatory Compliance Certification (RCC) Introducing Two new Certifications from RAPS

Presenter: – RAPS

Exhibit Hall: Career Central

Supported By

3:30 PM – 4:00 PM PDT

Meet the Authors: From X-Rays to AI: Navigating US Regulations in Radiological Health

Moderator: – RAPS

Presenter: – Abbott

Presenter: – Canon Medical Informatics, Inc.

3:30 PM – 4:30 PM PDT

RAPS Chapter/LNG Meet and Greet in Career Central

Exhibit Hall: Career CentralNetworking Opportunity

Supported By

3:45 PM – 4:15 PM PDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Guest Speaker: – CM Cooper & Associates

Guest Speaker: – Qserve Group

Guest Speaker:

Guest Speaker: – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

4:00 PM – 4:25 PM PDT

Sponsored Presentation: Managing the Regulatory Digital Thread - How Leading Medical Device Companies Elevate the Management of Regulatory Information

Speaker: – Kalypso: A Rockwell Automation Company

Presented by

4:00 PM – 4:25 PM PDT

Sponsored Presentation: Navigating the Future of Regulatory Affairs in MedTech With Regulatory Intelligence and Data-Driven Solutions

Speaker: – Essenvia

Presented by

4:00 PM – 4:25 PM PDT

Sponsored Presentation: The Role of the Regulatory Importer: Compliance, Responsibilities, and Best Practices

Speaker: – MedEnvoy Global BV

Presented by

4:00 PM – 4:30 PM PDT

Solution Circle (A): AI's Transformative Impact on CMC in Pharmaceuticals

Facilitator: – Neuron 23

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

4:00 PM – 4:30 PM PDT

Solution Circle (C): Navigating the New Era of Regulatory Affairs: Technology as a Catalyst for Transformation

Facilitator: – Integrated Project Management

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

4:00 PM – 4:30 PM PDT

Solution Circle (B): Clinical Decision Support Software vs. Software as a Medical Device

Facilitator: – Microsoft

Exhibit Hall: Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

4:30 PM – 5:30 PM PDT

Dive Deep: Navigating the Regulatory Maze of Concurrent Regulatory Submissions

Moderator: – Integrated Project Management

Presenter: – Entrada Therapeutics

Presenter: – Biogen

Presenter: – Novo Nordisk

Skill Building

4:30 PM – 5:30 PM PDT

Emerging Standard Developments in PFAS

Session Leader: – DEKRA Certification

Presenter: – TUV SUD

Devices (includes Medical Devices and In Vitro Diagnostics)

4:30 PM – 5:30 PM PDT

Failure Is Not An Option: How to Avoid and Recover From an IND Clinical Hold

Session Leader: – IAA Consulting LLC

Presenter: – UCB Biopharma

Presenter: – Amylaza Consulting, LLC

Biopharmaceuticals (includes Biologics and Drugs)

4:30 PM – 5:30 PM PDT

Global Tools to Expedite Advanced Therapy Product Development

Presenter: – KM Intel LLC

Presenter: – US Food and Drug Administration

Presenter (Remote): – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

4:30 PM – 5:30 PM PDT

Manufacturer's Approach to Advancing Health Equity for Medical Devices

Presenter/Moderator: – Veeva Systems

Presenter: – Medtronic

Presenter: – Philips

Devices (includes Medical Devices and In Vitro Diagnostics)

4:30 PM – 5:30 PM PDT

Regulatory Excellence: Japan's Type 1 Cartagena Process for Gene Therapy Products

Session Leader: – PPD, a part of Thermo Fisher Scientific

Presenter: – PPD-SNBL

Biopharmaceuticals (includes Biologics and Drugs)

4:30 PM – 5:30 PM PDT

What is New With Clinical Data Under the MDR? Interactive Panel Session With Notified Bodies

Session Leader: – Akra Team Inc.

Presenter: – BSI

Presenter: – TÜV Rheinland LGA Products GmbH

Presenter: – TÜV SÜD Product Service GmbH

Devices (includes Medical Devices and In Vitro Diagnostics)

5:45 PM – 7:15 PM PDT

Honoring Excellence: RAPS 2024 Awards Celebration (Invitation Only)

Separate Ticketed Event

6:00 PM – 9:00 PM PDT

Dine Arounds (Sign-up Required)

Reservation RequiredNetworking Opportunity

7:30 PM – 10:00 PM PDT

SOLD OUT Convergence Networking Party at Gaucho Beach (Separate Ticketed Event)

Separate Ticketed EventNetworking Opportunity