Full Schedule

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!

Proficiency: Foundational/ Operational/ Novice

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: – 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