Full Schedule

7:00 AM – 4:00 PM PDT

Registration Hours

7:00 AM – 4:00 PM PDT

Wellness Room

7:00 AM – 4:30 PM PDT

Speaker Ready Room

7:00 AM – 5:00 PM PDT

First Aid Office & Hours

7:30 AM – 8:30 AM PDT

Networking Breakfast & Welcome for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

8:30 AM – 4:00 PM PDT

Advanced Leadership Workshop (Day 1 of 2)

Workshop Leader: – COPIA Leadership

Preconference WorkshopSkill Building

8:30 AM – 4:00 PM PDT

Artificial Intelligence knocking on your door? The upcoming Artificial Intelligence Act’s Technical Documentation Requirements and how to integrate them into a Medical Device Regulation Submission

Workshop Leader: – BSI

Presenter: – BSI

Presenter: – TÜV SÜD Product Service GmbH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM PDT

Communicating with Agency Officials, Top Management, and Other Stakeholders for Gaining Alignment on Strategic Initiatives

Presenter: – DeRisio Group, LLC

Workshop Leader: – Compliance-Alliance, LLC

Presenter: – Johnson & Johnson MedTech, Vision

Preconference WorkshopOther

8:30 AM – 4:00 PM PDT

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

Workshop Leader: – Austrian Medicines and Medical Devices Agency

Presenter: – khhconsulting

Presenter: – Gilead Sciences

Presenter: – NDA Partners

Presenter: – European Medicines Agency

Presenter: – Malta Medicines Authority

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

8:30 AM – 4:00 PM PDT

Sharpening Your Regulatory Soft Skills Toolbox

Workshop Leader: – Wolters Kluwer UpToDate, Inc.

Presenter: – Lumos Diagnostics

Presenter: – Regulatory Affairs Professionals Society (RAPS)

Preconference WorkshopSkill Building

8:30 AM – 4:00 PM PDT

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

Proficiency: Foundational/ Operational/ Novice

Presenter: – DuVal & Associates, P.A.

Presenter: – RQM+

Presenter: – Histosonics

Presenter (Remote): – FDA/CDRH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

10:30 AM – 11:00 AM PDT

Networking Break for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

12:30 PM – 1:30 PM PDT

Networking Lunch for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

3:00 PM – 3:15 PM PDT

Afternoon Break for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

7:00 AM – 4:30 PM PDT

Speaker Ready Room

7:00 AM – 7:00 PM PDT

Wellness Room

7:00 AM – 7:30 PM PDT

Registration Hours

7:00 AM – 8:00 PM PDT

First Aid Office & Hours

7:30 AM – 8:30 AM PDT

Networking Breakfast & Welcome for Preconference Workshops Registrants (Workshop Registrants Only)

Facilitator: – RAPS

Preconference Workshops Only

8:00 AM – 5:00 PM PDT

RAPS Wellness Challenge

Networking Opportunity

8:00 AM – 5:00 PM PDT

Event App Support Desk Hours

8:00 AM – 6:00 PM PDT

RAPS Store Hours

8:30 AM – 4:00 PM PDT

Advanced Leadership Workshop (Day 2 of 2)

Workshop Leader: – COPIA Leadership

Preconference WorkshopSkill Building

8:30 AM – 4:00 PM PDT

Basics of Regulatory Strategy for the US & EU for Devices (includes Medical Devices and In Vitro Diagnostics)

Workshop Leader: – Veeva Systems

Presenter: – Philips

Presenter: – TÜV SÜD Medical Health Services

Presenter (Remote): – EMA

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM PDT

Maximizing Opportunities to Engage With the FDA

Workshop Leader: – BioMarin Pharmaceutical, Inc.

Workshop Leader: – Division of Regulatory Operations and Programs / Office of Regulatory Operations / Center for Biologics Evaluation and Research / Food and Drug Administration

Presenter: – BOLDAPPROVALS

Presenter: – FDA/CDER

Presenter: – ORMRR/OTP/CBER/FDA

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

8:30 AM – 4:00 PM PDT

MDR Surveillance, Post-Certification and Re-certification Submissions to Notified Bodies: Best Practice for Manufacturers

Workshop Leader: – BSI

Presenter: – BSI

Presenter: – DNV Product Assurance AS

Presenter: – LNE-GMED-UK

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM PDT

Strategy and Regulatory Intelligence (RI) Primer: How to Construct and Maintain it Using AI Tools

Presenter: – Regulatorium

Presenter: – Recursion Pharmaceuticals, Inc.

Preconference WorkshopSkill Building

8:30 AM – 4:00 PM PDT

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

Presenter: – DuVal & Associates, P.A.

Presenter: – RQM+

Presenter: – Histosonics

Presenter (Remote): – FDA/CDRH

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

10:30 AM – 11:00 AM PDT

Networking Break for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

12:30 PM – 1:30 PM PDT

Networking Lunch for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

2:30 PM – 3:30 PM PDT

Career Development Session for Students

Moderator: – RAPS

Presenter: – Lindsey Regulatory Affairs Consulting, LLC

Presenter: – Elemed

Presenter: – Qserve Group

Guest Speaker: – Northeastern University

Student Focus

3:00 PM – 3:15 PM PDT

Afternoon Break for Preconference Workshops Registrants (Workshop Registrants Only)

Preconference Workshops Only

4:30 PM – 5:00 PM PDT

Convergence 2024 Welcome!

Presenter: – Qserve Group

Presenter: – Regulatory Affairs Professionals Society (RAPS)

Presenter: – Thermo Fisher Scientific

Presenter: – Pfizer

Sponsor Speaker: – Celegence

Networking Opportunity

Supported By

5:00 PM – 6:00 PM PDT

RAPS Convergence 2024 Opening Plenary Session: Cross-Industry Insights: Leveraging AI to Elevate NextGen Regulatory

Moderator: – Thermo Fisher Scientific

Panelist: – MedSec LLC

Panelist: – City of Long Beach

Panelist: – Recursion Pharmaceuticals, Inc.

Panelist: – Epstein, Becker & Green

Networking Opportunity

6:00 PM – 7:30 PM PDT

Opening Reception & Welcome in the Exhibit Hall

Networking OpportunityExhibit Hall

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.

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

6:30 AM – 4:30 PM PDT

Speaker Ready Room

6:30 AM – 5:30 PM PDT

Wellness Room

7:00 AM – 8:00 AM PDT

Community Gathering & Morning Coffee

7:00 AM – 3:00 PM PDT

Registration Hours

7:00 AM – 6:00 PM PDT

First Aid Office & Hours

7:30 AM – 5:00 PM PDT

RAPS Store Hours

7:30 AM – 5:30 PM PDT

Event App Support Desk Hours

8:00 AM – 8:45 AM PDT

RAPS Convergence 2024 Plenary Session: Modern Challenges and Opportunities Within the Workspace

Moderator: – Pfizer

Panelist: – Northeastern University

Panelist: – Becton Dickinson

Panelist: – University of Houston College of Pharmacy

Networking Opportunity

8:00 AM – 5:00 PM PDT

RAPS Wellness Challenge

Networking Opportunity

8:45 AM – 9:00 AM PDT

Convergence 2024 Reflections and Preview of 2025

Speaker: – Alexion, AstraZeneca Rare Disease

Speaker: – Qserve Group

Networking Opportunity

9:15 AM – 10:30 AM PDT

China Drug Regulatory Pathways

Session Leader: – Cisema

Presenter: – PPD Inc

Biopharmaceuticals (includes Biologics and Drugs)

9:15 AM – 10:30 AM PDT

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

Moderator: – Alexion, AstraZeneca Rare Disease

Panelist (Remote): – United States Food and Drug Administration

Panelist: – European Medicines Agency

Panelist: – Botswana Medicines Regulatory Authority

Health Authority Session

9:15 AM – 10:30 AM PDT

Dangerous Documents: Avoiding Landmines in Your Records and Emails

Session Leader: – Compliance-Alliance, LLC

Presenter: – Wolters Kluwer UpToDate, Inc.

Presenter: – Hologic Inc.

Presenter: – OptimaPath Inc.

Skill Building

9:15 AM – 10:30 AM PDT

Initial Experience with Predetermined Change Control Plans and FDA’s PCCP Guidance / Principles

Moderator: – Hogan Lovells LLP

Presenter: – Medtronic

Presenter: – Amazon

Presenter: – Epitel

Presenter (Remote): – FDA

Devices (includes Medical Devices and In Vitro Diagnostics)

9:15 AM – 10:30 AM PDT

Notified Body Forum: State of Play EU MDR and EU IVDR

Session Leader: – AKRA TEAM

Presenter: – TÜV SÜD Medical Health Services

Presenter: – Qserve Group

Presenter: – DNV Product Assurance AS

Presenter: – BSI

Presenter: – Scarlet

Presenter: – GMED

Devices (includes Medical Devices and In Vitro Diagnostics)

9:15 AM – 10:30 AM PDT

Submission Strategies for Cybersecurity: Meeting the New Bar

Session Leader: – MedSec

Presenter: – Medtronic

Presenter: – BD

Presenter: – Bayer

Devices (includes Medical Devices and In Vitro Diagnostics)

9:15 AM – 10:30 AM PDT

The European Pharmaceutical Legislation Revision – Status Update and Ongoing Challenges

Session Leader: – KM Intel LLC

Presenter: – IPSEN PHARMA

Presenter: – Malta Medicines Authority

Presenter (Remote): – EMA

Biopharmaceuticals (includes Biologics and Drugs)

9:15 AM – 10:30 AM PDT

The MLR Ecosystem: Regulatory and Marketing Collaboration for Brand Success

Presenter: – Klick Health

Biopharmaceuticals (includes Biologics and Drugs)

10:30 AM – 11:00 AM PDT

Refreshment Break in the Exhibit Hall

Supported by

10:30 AM – 1:00 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Networking OpportunityExhibit Hall

10:30 AM – 3:30 PM PDT

Career Central Hours (Exhibit Hall: Booth 349)

Exhibit Hall

Supported By

10:30 AM – 3:30 PM PDT

Certification Lounge Hours (Exhibit Hall: Booth 225)

Exhibit Hall

10:30 AM – 3:30 PM PDT

Exhibit Hall Open

Networking OpportunityExhibit Hall

10:30 AM – 3:30 PM PDT

Headshot Lounge Hours (Exhibit Hall: Booth 1049)

Exhibit Hall

Supported by

10:30 AM – 3:30 PM PDT

RAPS Central Hours (Exhibit Hall: Booth 813)

Exhibit Hall

10:30 AM – 3:30 PM PDT

RAPS Community Giveback Hours (Exhibit Hall: Booth 425)

Exhibit Hall

10:30 AM – 3:30 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 – 3:30 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 – 3:30 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 – 3:30 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 Break Through the Regulatory Glass Ceiling and Get Hired!

Facilitator: – Novarum MDRQ Consulting

Exhibit Hall: Solutions CircleOther

10:35 AM – 11:05 AM PDT

Solution Circle (B): National Registrations and Other National Differences in the EU

Facilitator: – MDSS GmbH

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

10:35 AM – 11:05 AM PDT

Solution Circle (C): Submission of Implantable Medical Devices in Brazil: ANVISA's Class III and IV Requirements

Facilitator: – Vera Rosas Group

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

10:35 AM – 11:05 AM PDT

Solution Circle (D): The Impact of Regulatory Control Measures on Access to Opioid Analgesics used for Pain Management in Botswana

Facilitator: – Botswana Medicines Regulatory Authority

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

10:45 AM – 11:10 AM PDT

Sponsored Presentation: Embarking on the Journey of CDx Development

Speaker: – Cencora Pharmalex

Speaker: – Innomar Strategies Inc.

Presented by

10:45 AM – 11:10 AM PDT

Sponsored Presentation: How To Build Effective and Continuous Global Regulatory Intelligence Systems

Speaker: – MedBoard

Presented by

10:45 AM – 11:10 AM PDT

Sponsored Presentation: Technology-Enabled, Human-Centered Writing: GenAI Solutions for Regulatory Writers

Speaker: – Certara

Sponsored By:

10:45 AM – 11:15 AM PDT

Career Central Stage Sponsor Presentation: AI-Enhanced Medical Devices: Navigating the Regulatory Landscape and Ensuring Compliance

Speaker: – Intellias

Supported By

10:45 AM – 11:15 AM PDT

RAPS BOD Roundtable: Volunteering

Guest Speaker: – Abbott

Guest Speaker: – Mycovia Pharmaceuticals, Inc.

Guest Speaker: – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

11:10 AM – 11:40 AM PDT

Solution Circle (A): ADCs CMC – Regulatory Overreach or as Easy as ABC?

Facilitator: – Parexel Regulatory Consulting

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

11:10 AM – 11:40 AM PDT

Solution Circle (B): Diversity in Clinical Trials

Facilitator: – Lexicon Pharmaceuticals Inc.

Exhibit Hall: Solutions CircleOther

11:10 AM – 11:40 AM PDT

Solution Circle (C): Health Authority Audit and Inspection 101: Best Practices for Research Organizations

Facilitator: – Integrated Project Management

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

11:10 AM – 11:40 AM PDT

Solution Circle (D): PCCP - Predetermined Change Control Plan - Strategy With Case Studies for Medical Devices

Facilitator: – Siemens Healthineers

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

11:15 AM – 11:50 AM PDT

Sponsored Presentation: Redefine Regulatory Affairs with Human Expertise and AI-Powered Innovation

Speaker: – Freyr Solutions

Presented by

11:15 AM – 11:50 AM PDT

Sponsored Presentation: The Critical Role of Regulatory Affairs in Early-Stage Development: Case Studies Highlighting Successful Early Regulatory Involvement

Speaker: – Network Partners Group (NPG)

Presented by

11:15 AM – 11:50 AM PDT

Sponsored Presentation: The Digital Health Revolution: Where Are We Now and How Can We Prepare for the Future?

Speaker: – Clarivate

Presented by

11:30 AM – 12:00 PM PDT

Career Central Stage: Opportunities for Professionals & Students of Graduate Regulatory Education

Presenter: – University of Southern California

Presenter: – U.S. Public Health Service

Student FocusExhibit Hall: Career Central

Supported By

11:30 AM – 12:00 PM PDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Guest Speaker: – QuidelOrtho

Guest Speaker: – RAPS BoD

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

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

Solution Circle (A): China Drug Master Files: Latest Points to Know for Pharma Manufacturers

Facilitator: – Cisema

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

11:45 AM – 12:15 PM PDT

Solution Circle (B): Emerging Standard Developments in PFAS

Facilitator: – DEKRA Certification

Devices (includes Medical Devices and In Vitro Diagnostics)

11:45 AM – 12:15 PM PDT

Solution Circle (C): Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed Tests

Facilitator:

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

11:55 AM – 12:20 PM PDT

Sponsored Presentation: Generative AI and the Onslaught of Content: How to Keep Up in an Ever-Evolving Landscape

Speaker: – Klick Health

Speaker: – Klick

Presented by

11:55 AM – 12:20 PM PDT

Sponsored Presentation: The LDT/IVD Conundrum: Considerations for Risk Evaluation and Portfolio Management after FDA's Final LDT Rule

Speaker: – Pearl Pathways

Presented by

11:55 AM – 12:20 PM PDT

Sponsored Presentation: Typical Non-conformities and How to Address Them

Speaker: – BSI

Presented by

12:15 PM – 12:25 PM PDT

Career Central Stage: Student Capstone Presentation: Global MedRegs (Global Regulatory Requirements for Medical Devices) "Simplifying your Regulatory Journey Across International Markets”

Graduate Student Presenter: – NORTHEASTERN UNIVERSITY

Student FocusExhibit Hall: Career Central

Supported By

12:20 PM – 12:50 PM PDT

Solution Circle (A): Charting the Course: Interactive Breakout Session on Navigating FDA Communication

Facilitator: – Eximis Surgical

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

12:20 PM – 12:50 PM PDT

Solution Circle (B): USP’s Nitrosamines Exchange: Accelerating Pharmaceutical Quality Strategies

Facilitator: – U.S. Pharmacopeia

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

12:20 PM – 12:50 PM PDT

Solutions Circle (C): Failure is Not an Option: How to Avoid and Recover from an IND Clinical Hold

Facilitator: – Amylaza Consulting, LLC

Exhibit Hall: Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

12:25 PM – 12:50 PM PDT

Sponsored Presentation: Empowering Global Regulatory Affairs Professionals With Automated Surveillance Solutions

Speaker: – IQVIA

Presented by

12:25 PM – 12:50 PM PDT

Sponsored Presentation: The Path, Pitfalls, and the Use of RIM for Managing Regulatory Submissions

Speaker: – RegDesk, Inc.

Presented by

12:30 PM – 1:00 PM PDT

Writing for RAPS: A ‘How-to’ Guide for Books and Peer-Reviewed Content

Presenter: – Regulatory Affairs Professionals Society

Presenter: – RAPS

1:00 PM – 2:00 PM PDT

“Off-label" Information Communication — Recent Developments and Enforcement Trends in EU and US

Session Leader: – Siemens Healthineers

Presenter: – BSI

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

1:00 PM – 2:00 PM PDT

Best Practices for 510(k) Submissions Utilizing eSTAR

Session Leader: – Align Technology

Presenter: – Statera Regulatory Consulting

Presenter: – Regulatory Technology Services (RTS)

Devices (includes Medical Devices and In Vitro Diagnostics)

1:00 PM – 2:00 PM PDT

Controlling Pharmaceutical Impurities: A Regulatory Perspective

Presenter: – Hogan Lovells LLP

Presenter: – Paraxel

Biopharmaceuticals (includes Biologics and Drugs)

1:00 PM – 2:00 PM PDT

FDA Efforts to Promote Innovative Medical Product Development

Moderator: – FDA

Presenter: – FDA/CBER/OTP

Presenter: – Office of Program Operations, Office of New Drugs, CDER, FDA

Presenter (Remote): – Food and Drug Administration

Presenter (Remote): – Office of New Drugs, Center for Drug Evaluation and Research, U.S. FDA

Biopharmaceuticals (includes Biologics and Drugs)

1:00 PM – 2:00 PM PDT

Finding a Job in Regulatory Affairs or Regulatory Compliance: Skills for Success

Session Leader: – UCSC Silicon Valley Extension

Presenter: – Canon Medical Informatics, Inc.

Presenter (Remote): – ELIQUENT

Presenter (Remote): – CDRH, Food and Drug Administration

Skill Building

1:00 PM – 2:00 PM PDT

Regulatory Convergence of Biologics; APEC, ICH, WHO Efforts for LATAM and Around the World

Session Leader: – Northeastern University

Presenter: – US Food and Drug Administration

Presenter: – Northeastern University

Biopharmaceuticals (includes Biologics and Drugs)

1:00 PM – 2:00 PM PDT

Start Ups | Unlocking Success in MedTech Innovation: Navigating Regulatory Challenges for Startups and Spin-Offs

Presenter: – Qserve

Presenter: – Akra Team Inc.

Presenter: – Indigo

Devices (includes Medical Devices and In Vitro Diagnostics)

1:00 PM – 2:00 PM PDT

Structured Dialogue for (IVD) Medical Devices in Europe: Now Will Finally Get Some Answers

Presenter: – BSI

Presenter: – TÜV SÜD Medical Health Services

Presenter:

Presenter: – TüV Rheinland

Presenter: – Qserve Group

Moderator: – Thermo Fisher Scientific

Devices (includes Medical Devices and In Vitro Diagnostics)

2:00 PM – 2:30 PM PDT

Refreshment Break in the Exhibit Hall

Networking OpportunityExhibit Hall

Supported by

2:00 PM – 3:15 PM PDT

Exclusive Exhibit Hall Hours: Networking & Presentations

Networking OpportunityExhibit Hall

2:15 PM – 2:40 PM PDT

Sponsored Presentation: AI with ROI: Actionable Use Cases of Leveraging AI in Regulatory Affairs

Speaker: – NyquistAI

Presented by

2:15 PM – 2:40 PM PDT

Sponsored Presentation: Transforming Regulatory Affairs for the Age of AI and Cloud Computing

Speaker: – Philips

Presented by

2:15 PM – 3:15 PM PDT

Career Central Stage: Live LinkedIn Feedback Session

Presenter: – Elemed

Supported By

2:30 PM – 3:00 PM PDT

RAPS BOD Roundtable: I Am Regulatory

Guest Speaker: – Mycovia Pharmaceuticals, Inc.

Guest Speaker: – QuidelOrtho

RAPS BOD RoundtableExhibit Hall: RAPS CentralNetworking Opportunity

2:30 PM – 3:00 PM PDT

Solution Circle (A): Navigating Regulatory Pathways: When to Submit a Special 510(k) vs. Internal Letter-to-File for Device Changes (Bo

Facilitator: – MediView XR, Inc.

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

2:30 PM – 3:00 PM PDT

Solution Circle (B): Taking your Skills to the Next Level: Transform your Career

Facilitator: – UCSC Silicon Valley Extension

Exhibit Hall: Solutions CircleOther

3:15 PM – 4:15 PM PDT

Artificial Intelligence – Medical Devices and IVD’s conformity Assessment and CE Marking

Session Leader: – Elekta

Presenter: – BSI

Presenter: – TÜV SÜD Product Service GmbH

Devices (includes Medical Devices and In Vitro Diagnostics)

3:15 PM – 4:15 PM PDT

Expanding Global Access to Complex Generics: It is Time for Regulatory Convergence

Presenter: – United States Pharmacopeia

Presenter: – FDA/CDER/OGD

Presenter (Remote): – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

3:15 PM – 4:15 PM PDT

Health Authority Forum: CBER - FDA’s Center for Biologics Evaluation and Research (CBER)

Presenter (Remote): – United States Food and Drug Administration

Presenter: – US FDA

Moderator: – FDA/CBER/ORO/DROP/RABOB

Panel Facilitator: – UCB Biopharma

Health Authority Session

3:15 PM – 4:15 PM PDT

Impact of Public-Private Partnerships in Regulatory Science, Drug Development and Regulatory Decision-Making

Moderator: – Critical Path Institute

Presenter: – FDA / CDER

Presenter: – Abbvie

Presenter: – Critical Path Institute

Presenter (Remote): – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

3:15 PM – 4:15 PM PDT

Lessons Learned Since the Implementation of FDA’s Diversity Plans & an Assessment of the 2024 Diversity Action Plans FDA Guidance

Moderator: – BioMarin Pharmaceutical, Inc.

Presenter: – PhRMA

Presenter: – GSK

Presenter: – H1

Presenter (Remote): – FDA

Biopharmaceuticals (includes Biologics and Drugs)

3:15 PM – 4:15 PM PDT

Precision Medicine Using Companion Diagnostics, AI/ML Modeling, and Digital Health Technology? Buzzwords or Reality?

Presenter: – Kenai Therapeutics

Presenter: – APS Pharma Solutions

Presenter: – FDA Blueprint

Presenter (Remote): – EMA

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

3:15 PM – 4:15 PM PDT

Updates From the US and EU on Furthering the Advancements of Medical Device Development in Pediatrics

Session Leader: – Veeva Systems

Presenter: – Qserve Group

Presenter (Remote): – FDA

Devices (includes Medical Devices and In Vitro Diagnostics)

3:15 PM – 4:15 PM PDT

Using Foreign Data to and From China

Presenter: – China Med Device, LLC

Presenter/Moderator: – Takeda

Presenter: – Abbvie

Devices (includes Medical Devices and In Vitro Diagnostics)

4:30 PM – 5:30 PM PDT

A Path to Faster Breakthrough Device Commercialization - CDRH's Total Product Life Cycle Advisory Program (TAP)

Session Leader: – Hyman, Phelps & McNamara, P.C.

Presenter: – FDA

Devices (includes Medical Devices and In Vitro Diagnostics)

4:30 PM – 5:30 PM PDT

Addressing Menopause: From Unspoken Reality to Innovation Battlefield

Presenter: – confinis

Presenter: – Takeda

Presenter: – confinis ag

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

4:30 PM – 5:30 PM PDT

Advancing Gene Therapy: A Holistic Approach to Multicomponent Product Development and Delivery Device Lifecycle

Session Leader: – TPIreg, Innomar Strategies Inc

Presenter: – Health Cananda

Presenter: – US Food & Drug Administration

Biopharmaceuticals (includes Biologics and Drugs)

4:30 PM – 5:30 PM PDT

Considerations for Global Harmonization and Accelerated Drug Development

Presenter: – Gilead Sciences

Presenter: – European Medicines Agency

Presenter: – US Food and Drug Administration

Presenter: – Health Canada

Biopharmaceuticals (includes Biologics and Drugs)

4:30 PM – 5:30 PM PDT

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

Presenter (Remote): – Office of New Drugs, CDER, FDA

Panel Facilitator: – BioMarin Pharmaceutical, Inc.

Health Authority Session

4:30 PM – 5:30 PM PDT

Human Factors Development: Navigating Areas of Ambiguity and Insights for Creating Robust Regulatory Strategies

Session Leader: – Genentech

Presenter: – AstraZeneca

Presenter: – CP Pathways LLC

Biopharmaceuticals (includes Biologics and Drugs)

4:30 PM – 5:30 PM PDT

International Harmonization & Regulator Forum

Moderator: – Boston Scientific

Presenter: – Medical Technology Association of Australia

Presenter: – Botswana Medicines Regulatory Authority

Presenter (Remote): – Pharmacy and Poisons Board, Kenya

Panelist (Remote):

Presenter: – ABHI

Health Authority Session

4:30 PM – 5:30 PM PDT

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Session Leader: – Mid-Link Group

Devices (includes Medical Devices and In Vitro Diagnostics)

6:00 PM – 9:00 PM PDT

SOLD OUT (Advanced Sign-Up Required) RAPS Convergence 2024: Under the Sea Closing Party

Networking OpportunityReservation Required

Supported by