Full Schedule

6:30 AM – 10:00 AM EDT

Speaker Ready Room Hours

Location/Room: 512C

6:30 AM – 4:00 PM EDT

Registration Hours

7:00 AM – 8:00 AM EDT

Preconference Workshops: Breakfast & Networking for Registrants

8:00 AM – 8:30 AM EDT

Preconference Workshops: Welcome Workshop Registrants!

8:30 AM – 4:00 PM EDT

Common Pitfalls in Manufacturer Technical Documentation Submissions to Notified Bodies; Ways to Overcome These.

Location/Room: 511F

Presenter: – BSI Group

Presenter: – DNV Product Assurance AS

Presenter: – National Standards Authority of Ireland

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM EDT

Communication Toolkit for a Successful Regulatory Compliance Strategy

Location/Room: 510A

Presenter: – nexialist

Presenter: – GMED North America

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM EDT

What are the Requirements for an IND Submission?

Proficiency: Foundational/ Operational/ Novice

Location/Room: 510B

Workshop Leader: – HMC-Regulation

Presenter: – Synthego Corporation

Presenter: – Amplicore Inc

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

10:30 AM – 11:00 AM EDT

Preconference Workshops: Networking Break for Workshop Registrants

12:30 PM – 1:30 PM EDT

Preconference Workshops: Lunch & Networking for Registrants

6:30 AM – 4:00 PM EDT

Speaker Ready Room Hours

Location/Room: 512C

6:30 AM – 7:00 PM EDT

Registration Hours

Location/Room: Level 2 Registration Foyer

7:00 AM – 8:00 AM EDT

Preconference Workshops: Breakfast & Networking for Registrants

Location/Room: Level 5 Foyers

7:00 AM – 6:00 PM EDT

Event App Support Desk Hours

Location/Room: Level 2 Registration Foyer

8:00 AM – 8:30 AM EDT

Preconference Workshops: Welcome Workshop Registrants!

Location/Room: Level 5 Foyers

8:00 AM – 6:00 PM EDT

RAPS Store Hours

Location/Room: Level 2 Registration Foyer

8:30 AM – 4:00 PM EDT

Drug Development in EU: Regulatory Standards, Support and New Approaches

Location/Room: 510B

Presenter: – Austrian Medicines and Medical Devices Agency

Presenter: – khhconsulting

Presenter: – Spanish Agency for Medicines and Medical Devices

Presenter: – European Medicines Agency

Presenter: – Malta Medicines Authority

Presenter (Remote): – Granzer Regulatory Consulting & Services GmbH

Presenter: – NDA Partners

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

8:30 AM – 4:00 PM EDT

IVDR Technical Documentation Pre-conference Workshop

Location/Room: 511F

Presenter: – TUV Sud GmbH

Presenter: – NSAI

Presenter: – GMED Certification Division

Presenter: – BSI Group The Netherlands B.V.

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM EDT

PRRC – A New EU Requirement

Location/Room: 510A

Workshop Leader: – Akra Team GmbH

Presenter: – MD-CLINICALS SA

Presenter: – Qserve Group

Presenter: – DNV Product Assurance AS

Presenter: – Axon Lawyers

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

8:30 AM – 4:00 PM EDT

US Regulatory Essentials for Devices and IVDs

Location/Room: 511E

Presenter: – Independent

Presenter: – DuVal & Associates, P.A.

Presenter: – Greenlight Guru

Presenter: – AtriCure, Inc.

Presenter: – Qserve Group

Presenter (Remote): – Cook Incorporated

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

10:30 AM – 11:00 AM EDT

Preconference Workshops: Networking Break for Workshop Registrants

Location/Room: Level 5 Foyers

12:00 PM – 6:30 PM EDT

Press Office Hours

Location/Room: 512F

12:30 PM – 1:30 PM EDT

Preconference Workshops: Lunch & Networking for Registrants

2:30 PM – 3:30 PM EDT

Career Development Session for Students

Location/Room: 513F

Presenter: – Qserve Group

Presenter: – Elemed

Presenter: – Qserve Group BV

Presenter: – MEDIcept

Presenter: – University of Southern California

3:00 PM – 11:59 PM EDT

Wellness Challenge

Location/Room: Level 2 Registration Foyer

Networking Opportunity

3:30 PM – 4:00 PM EDT

Student Career Development Meet and Greet

Location/Room: 513F

4:30 PM – 6:00 PM EDT

RAPS Convergence 2023 Welcome & Opening Plenary Session: The Futuristic Regulatory Professional

Location/Room: 220B

Facilitator: – Velvet Chainsaw Consulting

Guest Speaker: – Regulatory Affairs Professionals Society (RAPS)

Guest Speaker: – Planning Committee Chair Convergence 2023

Moderator: – Thermo Fisher Scientific

Guest Speaker: – Qserve Group

Panelist: – European Medicines Agency

Panelist: – Cedience Inc.

Panelist: – Principled Impact

Panelist: – Health Canada

Panelist: – United States Food and Drug Administration

6:00 PM – 7:00 PM EDT

Opening Reception in Exhibit Hall

Location/Room: Exhibit Hall

Networking Opportunity

Sponsored By

12:00 AM – 11:59 PM EDT

Wellness Challenge

Location/Room: Level 2 Registration Foyer

Networking Opportunity

6:30 AM – 4:30 PM EDT

Speaker Ready Room Hours

Location/Room: 512C

6:30 AM – 6:00 PM EDT

Registration Hours

Location/Room: Level 2 Registration Foyer

7:00 AM – 8:00 AM EDT

Community Gathering & Continental Breakfast

Location/Room: Level 5 Foyer

Networking Opportunity

Supported By

7:00 AM – 6:00 PM EDT

Event App Support Desk Hours

Location/Room: Level 2 Registration Foyer

7:30 AM – 6:00 PM EDT

RAPS Store Hours

Location/Room: Level 2 Registration Foyer

7:30 AM – 7:00 PM EDT

Press Office Hours

Location/Room: 512F

8:00 AM – 9:15 AM EDT

Drug-Led Combination Products - Submission Guidance and Contents

Location/Room: 511D

Presenter: – Genentech and Roche

Presenter:

Presenter: – CP Pathways LLC

Q&A Presenter: – Genentech

Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters

8:00 AM – 9:15 AM EDT

Decoding Orphan Drug development: Bridging Boundaries and Thinking “Outside the Box”

Location/Room: 513D

Session Leader: – Allucent

Presenter (Remote): – European Medicines Agency

Presenter: – Jazz Pharmaceuticals

Presenter: – ADRES, Advanced Regulatory Services Israel Ltd.

Biopharmaceuticals (includes Biologics and Drugs)

8:00 AM – 9:15 AM EDT

EU-MDR Implementation: Latest News

Location/Room: 511E

Moderator: – TÜV SÜD

Moderator: – Akra Team GmbH

Presenter (Remote): – European Commission, Directorate-General Health and Food safety

Presenter: – Qserve Group

Presenter: – BSI

Devices (includes Medical Devices and In Vitro Diagnostics)

8:00 AM – 9:15 AM EDT

Health Authority Forum: European Medicines Agency (EMA)

Location/Room: 510B

Moderator: – European Medicines Agency

Presenter: – European Medicines Agency

Presenter: – Austrian Medicines and Medical Devices Agency

Presenter: – European Medicines Agency

Presenter (Remote): – European Medicines Agency

Health Authority Forum

8:00 AM – 9:15 AM EDT

Maximizing the Impact of Patient-centric Data: Meaningful Interactions Informing Regulatory Decision-making.

Location/Room: 513B

Moderator: – PhRMA

Presenter: – FDA

Presenter: – Pfizer

Presenter (Remote):

Presenter: – Sumitomo Pharma America, Inc.

Biopharmaceuticals (includes Biologics and Drugs)

8:00 AM – 9:15 AM EDT

Risk Management – The Importance of Lifecycle Traceability

Location/Room: 510A

Session Leader: – MEDIcept

Presenter: – MEDIcept Inc.

Devices (includes Medical Devices and In Vitro Diagnostics)

8:00 AM – 9:15 AM EDT

Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs

Location/Room: 513F

Moderator: – Alexion, AstraZeneca Rare Disease

Presenter:

Presenter: – Network Partners Group

Presenter: – University of Georgia

Presenter: – Elemed

Presenter: – RAPS

Skill Building

9:30 AM – 10:30 AM EDT

Plenary Session: Regulatory, Policy, and Societal Challenges of Psychedelics and the Path Forward

Location/Room: 220B

Moderator: – Alexion, AstraZeneca Rare Disease

Panelist: – European Medicines Agency

Panelist: – Worldwide Clinical Trials

10:30 AM – 11:00 AM EDT

Coffee Break in the Exhibit Hall

Location/Room: Exhibit Hall

10:30 AM – 2:30 PM EDT

Certification Lounge Hours

Location/Room: Exhibit Hall: Certification Lounge (Booth 131)

10:30 AM – 2:30 PM EDT

Exhibit Hall Hours

Location/Room: Exhibit Hall

Networking Opportunity

10:30 AM – 2:30 PM EDT

Headshot Lounge Hours

Location/Room: Exhibit Hall: Headshot Lounge (Booth 839)

Sponsored By

10:30 AM – 2:30 PM EDT

Regulatory Cares Community Giveback Booth Hours

Location/Room: Exhibit Hall (Booth 115)

10:30 AM – 2:30 PM EDT

Student Capstone Poster Display: Survey of Clinical Trial Data of Immune Checkpoint Inhibitors – Avelumab and Cemiplimab

Location/Room: Exhibit Hall: Career Central (Booth 633)

Graduate Student Presenter: – University of Southern California

10:30 AM – 2:30 PM EDT

Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab

Location/Room: Exhibit Hall: Career Central (Booth 633)

Graduate Student Presenter: – USC

10:45 AM – 11:10 AM EDT

Sponsored Presentation: A combination Products Perspective on IDMP Implementation

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – ArisGlobal

Presented by

10:45 AM – 11:10 AM EDT

Sponsored Presentation: Considerations for Successful PMCF Survey Implementation

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – Purdie Pascoe

Presented by

10:45 AM – 11:10 AM EDT

Sponsored Presentation: Talent Management Strategies: The Hiring and the Hired

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – Shurig Solutions, Inc

Presented by

10:45 AM – 11:15 AM EDT

Solutions Circle: How Soon Can I Implement This? "Navigating FDA Submissions and Review Logistics: A One-Stop Guide

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Pharnext

Facilitator: – CMC-RX Consulting

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

10:45 AM – 11:15 AM EDT

Solutions Circle: A Roadmap of Expedited Pathways in Europe - The Fast for the Curious

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Parexel International

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

10:45 AM – 11:15 AM EDT

Solutions Circle: Biosimilar Regulations in Middle East - Challenges and Proposed Solutions

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Regweb Consulting Services Inc.

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

10:45 AM – 11:15 AM EDT

Solutions Circle: eCTD Module 3, How Much Detail Do I Submit?

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Certara Drug Development Solutions

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

11:00 AM – 11:15 AM EDT

Student Capstone Oral Presentation: Patient-Focused Drug Development and the 21st Century Cures Act: A Qualitative Case-Control Study

Location/Room: Exhibit Hall: Career Central (Booth 633)

Graduate Student Presenter: – The George Washington University

11:00 AM – 11:30 AM EDT

RAPS BOD Roundtable: Emerging Regulatory Trends

Location/Room: RAPS Central (Exhibit Hall: Booth #610)

Guest Speaker: – Planning Committee Chair Convergence 2023

Guest Speaker: – Salditt Regulatory Consulting LLC

Guest Speaker: – MEDIcept

Guest Speaker: – Candel Therapeutics

11:15 AM – 11:40 AM EDT

Sponsored Presentation: How AI will Power the Future of Proofreading in Pharma

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – GlobalVision

Presented by

11:15 AM – 11:40 AM EDT

Sponsored Presentation: Improve Time to Value with Integrated Product and Regulatory Data

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – Kalypso: A Rockwell Automation Company

Speaker: – Zimmer Biomet

Presented by

11:15 AM – 11:40 AM EDT

Sponsored Presentation: Using AI/ML Technology to Improve Regulatory Efficiency by 60%

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – Clarivate

Presented by

11:15 AM – 12:00 PM EDT

Chapter Meet and Greet at Career Central

Networking Opportunity

11:25 AM – 11:55 AM EDT

Solutions Circle: 5 Ways that an RA Department Will be Impacted by IDMP Data Standards

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – NNIT

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

11:25 AM – 11:55 AM EDT

Solutions Circle: Enabling Earlier Access to Medicines in Latin America by Rationalizing Legalization Requirements

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Roche

Facilitator: – Merck KGaA

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

11:25 AM – 11:55 AM EDT

Solutions Circle: Q&A on the EU General Pharmaceutical Legislation Revision

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Alexion, AstraZeneca Rare Disease

Solutions Circle

11:25 AM – 11:55 AM EDT

Solutions Circle: Regulatory Strategy for Market Entry to China for Drug Master Filing (DMF)

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Cisema

Solutions Circle

11:45 AM – 12:00 PM EDT

Student Capstone Oral Presentation: Australia Market Access Strategy of Novel Drug with Companion Diagnostic Test Kit for Breast Cancer

Location/Room: Exhibit Hall: Career Central (Booth 633)

Graduate Student Presenter: – The University of Southern California

11:45 AM – 12:10 PM EDT

Sponsored Presentation: Improving Operational Excellence and Patient Safety with MDDAP

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – ISACA

Presented by

11:45 AM – 12:10 PM EDT

Sponsored Presentation: Steps to Prepare for Effective EUDAMED Product Data Syndication

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – USDM Life Sciences

Speaker: – 1WorldSync, Inc.

Presented by

11:45 AM – 12:10 PM EDT

Sponsored Presentation: UDI Essentials for Regulatory Affairs Teams

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – Rimsys

Presented by

11:45 AM – 12:15 PM EDT

RAPS BOD Roundtable: I Am Regulatory

Location/Room: RAPS Central (Exhibit Hall: Booth #610)

Guest Speaker: – TÜV SÜD

Guest Speaker:

Guest Speaker: – QuidelOrtho

Guest Speaker: – Candel Therapeutics

12:00 PM – 1:00 PM EDT

RAPS BOD Roundtable: Volunteering

Location/Room: RAPS Central (Exhibit Hall: Booth #610)

Guest Speaker: – TÜV SÜD

Guest Speaker:

12:00 PM – 1:30 PM EDT

Networking Lunch in Exhibit Hall

Location/Room: Exhibit Hall

Networking Opportunity

Supported By

12:05 PM – 12:35 PM EDT

Solutions Circle: Medical Device EU MDR Lessons Learned with Two Different Notified Bodies

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Abbott

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

12:05 PM – 12:35 PM EDT

Solutions Circle: Methodologies for Building a Software Predetermined Change Control Plan and Algorithm Change Plan for AI/ML

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Hogan Lovells LLP

Solutions Circle

12:05 PM – 12:35 PM EDT

Solutions Circle: Sourcing Comparators and Other Study Drugs for Global Clinical Trials

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Genentech, Inc.

Solutions Circle

12:05 PM – 12:35 PM EDT

Solutions Circle: Strategies for Holistic Labeling: Information Consolidation, Process Orchestration, Intelligent Automation & Resource Augmentation

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – IQVIA

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

12:15 PM – 12:40 PM EDT

Sponsored Presentation: Global SSCP/SSP Implementation: Navigating the Challenges, Solutions, and Best Practices

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – Acolad Life Sciences

Presented by

12:15 PM – 12:40 PM EDT

Sponsored Presentation: How to Optimize a MDSAP/EU compliant QMS, including feedback on common issues

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – Emergo by UL

Presented by

12:15 PM – 12:40 PM EDT

Sponsored Presentation: Reimagine Regulatory Affairs in The Era of Generative AI

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – NyquistAI

Sponsored By

12:45 PM – 1:10 PM EDT

Sponsored Presentation: Synergies for the EU Authorised Representative, UK Responsible Person and Swiss Authorised Representative

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – MDSS GmbH

Presented by

12:45 PM – 1:10 PM EDT

Sponsored Presentation: Unlocking China's Market: A Guide to Overcome Access Barriers for Medical Devices

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – BradyKnows Medical Group

Presented by

12:45 PM – 1:10 PM EDT

Sponsored Presentation: Unveiling MoCRA: Revolutionizing Cosmetics Regulation and Empowering Manufacturers

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – The FlexPro Group

Speaker: – Network Partners

Speaker: – The FlexPro Group

Presented by

12:45 PM – 1:15 PM EDT

Solutions Circle: Annex XVI State of Play

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – DNV Product Assurance AS

Presenter: – BSI

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

12:45 PM – 1:15 PM EDT

Career Central Stage: Get your Regulatory Compliance Certification (RCC): Introducing Two New Compliance Certifications

Location/Room: Exhibit Hall: Career Central (Booth 633)

Speaker: – RAPS

Career Central Stage

12:45 PM – 1:15 PM EDT

Solutions Circle: Getting it Right the First Time - Where Regulatory and Design Intersect; Accuracy/Acceptance Criteria

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Qserve Group US

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

12:45 PM – 1:15 PM EDT

RAPS Store Stage: Meet the Authors - Regulation of Regenerative Medicines: A Global Perspective

Location/Room: RAPS Store Stage (Level 2 Registration Foyer)

Speaker: – Mycovia Pharmaceuticals, Inc.

Speaker: – Lisata Therapeutics

RAPS Store Stage

12:45 PM – 1:15 PM EDT

Solutions Circle: Regulatory Intelligence Solutions Circle

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Lifescan

Solutions CircleSkill Building

12:45 PM – 1:15 PM EDT

Solutions Circle: US Combination Products Updates: What You Need to Know!

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – MEDIcept

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

12:45 PM – 1:45 PM EDT

RAPS Fellows Speed Mentoring at Career Central (Sign-up Required)

Location/Room: Exhibit Hall: Career Central (Booth 633)

Networking Opportunity

2:00 PM – 3:00 PM EDT

Anatomy of a Tweet – How to Promote on the Socials in a MedDev Regulatory Environment.

Location/Room: 511F

Session Leader: – Abbott Laboratories

Presenter: – Abbott Laboratories

Presenter: – Axon Lawyers

Devices (includes Medical Devices and In Vitro Diagnostics)

2:00 PM – 3:00 PM EDT

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

Location/Room: 511E

Moderator: – Alexion, AstraZeneca Rare Disease

Moderator: – Candel Therapeutics

Panelist: – Malta Medicines Authority

Panelist: – Health Canada

Panelist: – European Medicines Agency

Panelist: – TÜV SÜD

Panelist: – khhconsulting

Panelist: – Austrian Medicines and Medical Devices Agency

Panelist: – European Medicines Agency

Panelist: – United States Food and Drug Administration

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

Conversations That Matter

2:00 PM – 3:00 PM EDT

Drug Marketing Approval Pathways in China: 2023 Latest Updates, Accelerated Pathways & Market Challenges

Location/Room: 513B

Session Leader: – Cisema

Presenter: – Accestra Consulting

Presenter: – PTC Therapeutics, Inc.

Biopharmaceuticals (includes Biologics and Drugs)

2:00 PM – 3:00 PM EDT

FDA Expectations for using Digital Tools in Decentralized Clinical Trials

Location/Room: 513D

Session Leader: – EMD Serono

Presenter: – Novo Nordisk

Presenter (Remote): – FDA

Presenter (Remote): – US FDA

Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters

2:00 PM – 3:00 PM EDT

FDA Forecast 2024: What Pharmaceutical and Biotech Regulatory Professionals can Expect from FDA Next Year

Location/Room: 511D

Session Leader: – POLITICO's AgencyIQ

Moderator: – Accumulus Synergy

Presenter: – The Pink Sheet

Biopharmaceuticals (includes Biologics and Drugs)

2:00 PM – 3:00 PM EDT

Seven Key Qualities of a Successful Regulatory Leader and How to Develop Them

Location/Room: 513F

Session Leader: – Medtronic Endoscopy

Moderator: – Veeva Systems

Skill Building

2:00 PM – 3:00 PM EDT

Transforming Patient Engagement in Medical Technologies' Evolving Regulatory Landscape

Location/Room: 510B

Moderator: – Boston Scientific

Presenter: – Abbott

Presenter: – Medtronic

Presenter: – Exact Sciences

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

Devices (includes Medical Devices and In Vitro Diagnostics)

2:00 PM – 3:00 PM EDT

UDI & Global Supply Chain Compliance

Location/Room: 510A

Session Leader: – Veeva MedTech

Presenter: – USDM Life Sciences

Devices (includes Medical Devices and In Vitro Diagnostics)

3:00 PM – 3:30 PM EDT

Coffee & Refreshment Break

Location/Room: Level 5 Foyer

Networking Opportunity

Supported By

3:30 PM – 4:30 PM EDT

Advancing Health Equity, a Strategic Priority for FDA/CDRH and Health Canada

Location/Room: 513B

Moderator: – Veeva Systems

Presenter: – Health Canada

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

Devices (includes Medical Devices and In Vitro Diagnostics)

3:30 PM – 4:30 PM EDT

Ensuring Patient Registries Support Regulatory Decision-Making

Location/Room: 510B

Presenter: – BioMarin Pharmaceutical Inc.

Presenter: – Austrian Medicines and Medical Devices Agency

Presenter: – World Federation of Hemophilia

Presenter (Remote): – European Medicines Agency (EMA)

Moderator: – BioMarin Pharmaceuticals, Inc.

Biopharmaceuticals (includes Biologics and Drugs)

3:30 PM – 4:30 PM EDT

EU-MDR Notified Body Forum

Location/Room: 511E

Moderator: – TÜV SÜD

Moderator: – Akra Team GmbH

Presenter: – BSI

Presenter: – DNV Product Assurance AS

Presenter: – TUV SUD

Presenter: – GMED Certification Division

Devices (includes Medical Devices and In Vitro Diagnostics)

3:30 PM – 4:30 PM EDT

FDA Forecast 2024: What Device and Diagnostics Regulatory Professionals can Expect from FDA Next Year

Location/Room: 510A

Presenter: – POLITICO's AgencyIQ

Moderator: – Veeva Systems

Presenter: – POLITICO's AgencyIQ

Devices (includes Medical Devices and In Vitro Diagnostics)

3:30 PM – 4:30 PM EDT

Industry Experience with Implementing ICH Q12 in US and Canada

Location/Room: 511D

Presenter: – Genentech, Inc.

Biopharmaceuticals (includes Biologics and Drugs)

3:30 PM – 4:30 PM EDT

Regulatory Framework of AI/ML Enabled Medical Devices in the U.S. and EU.

Location/Room: 511F

Presenter: – Siemens Healthineers

Presenter: – TÜV SÜD GmbH

Moderator: – Axon Lawyers

Devices (includes Medical Devices and In Vitro Diagnostics)

3:30 PM – 4:30 PM EDT

Navigating Global Regulatory Frameworks for Cell and Gene Therapy Development

Location/Room: 513D

Session Leader: – Dark Horse Consulting Group

Presenter: – POLITICO’s AgencyIQ

Presenter (Remote): – European Medicines Agency

Biopharmaceuticals (includes Biologics and Drugs)

3:30 PM – 4:30 PM EDT

The Future of Regulatory Affairs In An Everchanging World

Location/Room: 513F

Session Leader: – Worldwide Clinical Trials

Presenter: – Seagen Inc.

Skill Building

4:45 PM – 5:45 PM EDT

Challenges in Implementation of IVDR Requirements for CDx Clinical Performance Studies

Location/Room: 513F

Moderator: – Seagen, Inc

Presenter: – European Medicines Agency

Presenter: – Merck KGaA, Darmstadt, Germany

Presenter: – GSK

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

4:45 PM – 5:45 PM EDT

Efficient Product Master Data Management: FDA , EUDAMED, and other Medical Device Registry submission/Syndication.

Location/Room: 510A

Session Leader: – Item Alignment Inc.

Presenter: – USDM Life Sciences

Devices (includes Medical Devices and In Vitro Diagnostics)

4:45 PM – 5:45 PM EDT

FDA Proposed New ACNU NDA: A Novel Regulatory Pathway for Increasing Patient Access and Lifecycle Management

Location/Room: 513D

Session Leader: – Beacon Associates, LLC

Presenter: – Food and Drug Administration

Presenter (Remote): – US Food and Drug Administration

Presenter: – Klick Consulting

Moderator: – Haleon

Biopharmaceuticals (includes Biologics and Drugs)

4:45 PM – 5:45 PM EDT

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

Location/Room: 510B

Moderator: – IAA Consulting LLC

Presenter (Remote): – FDA

Presenter (Remote): – US FDA

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

Health Authority Forum

4:45 PM – 5:45 PM EDT

Making an Impact to Bring Further Diversity and Inclusion in Clinical Research

Location/Room: 513B

Session Leader: – Worldwide Clinical Trials

Presenter: – Worldwide Clinical Trials

Biopharmaceuticals (includes Biologics and Drugs)

4:45 PM – 5:45 PM EDT

Latest Updates on Clinical Evidence – Panel Discussion with a Consultant and 3 Notified Bodies

Location/Room: 511F

Session Leader: – Akra Team Inc.

Presenter: – TÜV SÜD Product Service GmbH

Presenter: – BSI

Presenter: – TÜV Rheinland LGA Products GmbH

Devices (includes Medical Devices and In Vitro Diagnostics)

4:45 PM – 5:45 PM EDT

Regulatory Opportunities and Challenges with mRNA Technology – Lessons Learned from the COVID-19 Pandemic

Location/Room: 511D

Presenter: – Moderna

Biopharmaceuticals (includes Biologics and Drugs)

4:45 PM – 5:45 PM EDT

When to “Factor” in Human Factors

Location/Room: 511E

Presenter: – Agilis by Kymanox

Devices (includes Medical Devices and In Vitro Diagnostics)

6:00 PM – 7:15 PM EDT

Honoring Excellence: RAPS 2023 Awards Celebration (by Invitation Only)

Location/Room: OFFSITE: Doubletree Hotel - The HUB, Lobby Level

Networking Opportunity

Sponsored By

6:00 PM – 9:00 PM EDT

Dine-Arounds

Location/Room: Level 2 Registration Foyer

Networking Opportunity

7:30 PM – 10:00 PM EDT

SOLD OUT - Convergence Networking Party (ticket required)

Location/Room: OFFSITE: Le Cathcart Restaurant & Biergarten

Networking Opportunity

Sponsored By

12:00 AM – 5:00 PM EDT

Wellness Challenge

Location/Room: Level 2 Registration Foyer

Networking Opportunity

6:30 AM – 3:00 PM EDT

Registration Hours

Location/Room: Level 2 Registration Foyer

6:30 AM – 4:30 PM EDT

Speaker Ready Room Hours

Location/Room: 512C

6:30 AM – 7:00 PM EDT

Luggage Check

Location/Room: Level 1

7:00 AM – 8:00 AM EDT

Community Gathering & Continental Breakfast

Networking Opportunity

Sponsored By

7:30 AM – 5:00 PM EDT

RAPS Store Hours

Location/Room: Level 2 Registration Foyer

7:30 AM – 6:00 PM EDT

Press Office Hours

Location/Room: 512F

8:00 AM – 9:15 AM EDT

Actionable Steps to Meeting Regulatory and Ethical Considerations in Clinical Trial Diversity

Location/Room: 513D

Session Leader: – Moderna

Presenter (Remote): – FDA

Presenter: – PhRMA

Presenter: – Moderna

Moderator: – BioMarin Pharmaceuticals, Inc.

Biopharmaceuticals (includes Biologics and Drugs)

8:00 AM – 9:15 AM EDT

Considerations for Cannabidiol Product Development: The Regulatory Landscape and Safety Concerns.

Location/Room: 513F

Presenter: – American Association for the Advancement of Science/USDA

Presenter: – Allucent

Presenter: – Food and Drug Administration

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

8:00 AM – 9:15 AM EDT

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

Location/Room: 511E

Moderator: – Alexion, AstraZeneca Rare Disease

Moderator: – Candel Therapeutics

Panelist: – European Medicines Agency

Panelist: – TÜV SÜD

Panelist: – Health Canada

Panelist: – MEDIcept

Conversations That Matter

8:00 AM – 9:15 AM EDT

Drug-Device Combination Products: The Why Behind the Regulatory Strategy

Location/Room: 510B

Session Leader: – Takeda

Presenter (Remote): – BSI Group

Devices (includes Medical Devices and In Vitro Diagnostics)

8:00 AM – 9:15 AM EDT

What can Legacy Manufacturers Learn from Effective PMS and PMPF Implementation in Order to Prepare to Become IVDR compliant?

Location/Room: 510A

Session Leader: – BSI Group The Netherlands B.V.

Presenter: – Dr. Ebeling & Assoc. GmbH

Presenter: – Abbott

Presenter: – NSAI

Devices (includes Medical Devices and In Vitro Diagnostics)

8:00 AM – 9:15 AM EDT

Get the 411 on 1.14 (It's More Than Just Compliant Labeling!)

Location/Room: 511D

Session Leader: – Desai RA Consultants, LLC

Presenter: – Peay Regulatory Affairs Consulting, LLC

Presenter: – Pharming Healthcare, Inc.

Presenter: – APS Pharma Solutions, LLC

Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters

8:00 AM – 9:15 AM EDT

Lessons on the EU-Clinical Trials Regulation

Location/Room: 511F

Session Leader: – Worldwide Clinical Trials

Presenter: – Worldwide Clinical Trials

Presenter: – European Medicines Agency

Presenter: – MMS Holdings

Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters

8:00 AM – 9:15 AM EDT

Medical Device Cybersecurity: Planning a Global Strategy

Location/Room: 513B

Session Leader: – MEDSEC

Presenter (Remote): – US FDA

Devices (includes Medical Devices and In Vitro Diagnostics)

9:30 AM – 10:30 AM EDT

Plenary Session: RAPS Patient-Centered Health Award Presentation and Panel Discussion: Progressing Patient-Centered Health Through Collaboration: A TransCelerate Multi-Stakeholder Panel

Location/Room: 220 B

Keynote Speaker: – TransCelerate BioPharma Inc.

Panelist: – Janssen Pharmaceuticals

Panelist: – European Medicines Agency

Panelist: – Merck KGaA, Darmstadt, Germany

Panelist: – United States Food and Drug Administration

10:30 AM – 11:00 AM EDT

Coffee Break in the Exhibit Hall

Location/Room: Exhibit Hall

10:30 AM – 2:30 PM EDT

Certification Lounge Hours

Location/Room: Exhibit Hall: Certification Lounge (Booth 131)

10:30 AM – 2:30 PM EDT

Exhibit Hall Hours

Location/Room: Exhibit Hall

Networking Opportunity

10:30 AM – 2:30 PM EDT

Headshot Lounge Hours

Location/Room: Exhibit Hall: Headshot Lounge (Booth 839)

Sponsored By

10:30 AM – 2:30 PM EDT

Regulatory Cares Community Giveback Booth Hours

Location/Room: Exhibit Hall (Booth 115)

10:30 AM – 2:30 PM EDT

Student Capstone Poster Display: Survey of Clinical Trial Data of Immune Checkpoint Inhibitors – Avelumab and Cemiplimab

Location/Room: Exhibit Hall: Career Central (Booth 633)

Graduate Student Presenter: – University of Southern California

10:30 AM – 2:30 PM EDT

Student Capstone Poster Display: Clinical Paradigms in Immune Checkpoint Inhibitors: Pembrolizumab, Durvalumab, and Atezoliuzmab

Location/Room: Exhibit Hall: Career Central (Booth 633)

Graduate Student Presenter: – USC

10:45 AM – 11:10 AM EDT

Sponsored Presentation: Drive on the Regulatory Autobahn – Stretch Your Team with No Speed Limit

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – Integrated Project Management Company, Inc.

Speaker: – Integrated Project Management

Presented by

10:45 AM – 11:10 AM EDT

Sponsored Presentation: Risk Strategy & Risk Management for Medical Devices

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – Fang Consulting

Presented by

10:45 AM – 11:10 AM EDT

Sponsored Presentation: What’s Next: The Evolution of Regulatory Submissions and Technology

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – Certara

Presented by

10:45 AM – 11:15 AM EDT

Solutions Circle: What you need to know about the EU-Clinical Trials Regulation

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Worldwide Clinical Trials

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters

10:45 AM – 11:15 AM EDT

Solutions Circle: EU/MDR State of Play

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – TÜV SÜD

Facilitator: – Akra Team GmbH

Facilitator: – Qservegroup

Facilitator: – BSI

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters

10:45 AM – 11:15 AM EDT

Solutions Circle: Pediatric Drug Development: Failure is not an Option

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – IAA Consulting LLC

Facilitator: – khhconsulting

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters

10:45 AM – 11:15 AM EDT

Solutions Circle: Regulatory Trends and Opportunities for Drug Delivery Combination Products

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Genentech and Roche

Facilitator: – Genentech

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters

11:00 AM – 11:30 AM EDT

RAPS BOD Roundtable: Emerging Regulatory Trends

Location/Room: RAPS Central (Exhibit Hall: Booth #610)

Guest Speaker: – Candel Therapeutics

Guest Speaker: – MEDIcept

11:15 AM – 11:40 AM EDT

Sponsored Presentation: Crossing the eSTAR Chasm: How to Transition to FDA’s Mandatory 510(k) eSTAR Submission Process

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Presenter: – Essenvia

Presented by

11:15 AM – 11:40 AM EDT

Sponsored Presentation: FDA Forecast: The Biggest Issues Facing the FDA in 2024

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – POLITICO's AgencyIQ

Presented by

11:15 AM – 12:00 PM EDT

Student Mix 'n Mingle at Career Central

Location/Room: Exhibit Hall: Career Central (Booth 633)

Networking Opportunity

11:15 AM – 11:40 PM EDT

Sponsored Presentation: Optimizing CER and PMS Document Writing with Technology and AI

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – Celegence

Presented by

11:25 AM – 11:55 AM EDT

Solutions Circle: How to Improve Your Regulatory Interactions by Practicing Speaking and Active Listening Skills

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Neuron23, Inc.

Facilitator: – Integrated Project Management Company, Inc.

Solutions CircleSkill Building

11:25 AM – 11:55 AM EDT

RAPS Store Stage: Writing for RAPS - All You Need to Know About Submitting Content for RAPS Publications

Location/Room: RAPS Store Stage (Level 2 Registration Foyer)

RAPS Store Stage

11:25 AM – 11:55 AM EDT

Solutions Circle: FDA Expectations for Digital Health Tools in Decentralized Clinical Trials

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – EMD Serono

Facilitator: – Novo Nordisk

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters

11:25 AM – 11:55 AM EDT

Solutions Circle: Deep Dive into Labeling Operations

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Desai RA Consultants, LLC

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)Conversation Starters

11:25 AM – 11:55 AM EDT

Solutions Circle: Trends on Orphan and Pediatric Regulatory Frameworks

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Alexion, AstraZeneca Rare Disease

Solutions Circle

11:45 AM – 12:10 PM EDT

Sponsored Presentation: Pharmaceuticals, Medical Devices, OTC’s and now Cosmetics – What to watch out for when managing a Product Recall

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – Sedgwick

Presented by

11:45 AM – 12:10 PM EDT

Sponsored Presentation: PMS Beyond Regulations

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – DQS Medizinprodukte UK Ltd

Speaker: – DQS Medizinprodukte GmbH

Presented by

11:45 AM – 12:10 PM EDT

Sponsored Presentation: Sustainability: potential challenges and solutions for the MedTech industry, Notified Bodies and auditing organizations.

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – BSI Group

Presented by

11:45 AM – 12:15 PM EDT

Career Central Stage: The RAPS Competency Framework and Tools: What is it and what's in it for me?

Location/Room: Exhibit Hall: Career Central (Booth 633)

Speaker: – QRE MedTech LLC

Speaker: – Day One Biopharmaceuticals

Career Central Stage

11:45 AM – 12:15 PM EDT

RAPS BOD Roundtable: The Futuristic Regulatory Professional

Location/Room: RAPS Central (Exhibit Hall: Booth #610)

Guest Speaker: – Planning Committee Chair Convergence 2023

Guest Speaker: – NDA Partners

Guest Speaker: – Salditt Regulatory Consulting LLC

Guest Speaker: – MEDIcept

12:00 PM – 1:30 PM EDT

Networking Lunch in Exhibit Hall

Location/Room: Exhibit Hall

Networking Opportunity

Supported By

12:05 PM – 12:35 PM EDT

Solutions Circle: Notified Bodies: IVDR implementation Ask me Anything

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – DEKRA

Facilitator: – GMED Certification Division

Facilitator: – BSI Group The Netherlands B.V.

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters

12:05 PM – 12:35 PM EDT

Solutions Circle: The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – DuVal & Associates, P.A.

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters

12:05 PM – 12:35 PM EDT

Solutions Circle: The Journey to RAC!

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Integrated Project Management

Facilitator: – Integrated Project Management, Inc.

Facilitator: – RAPS

Solutions CircleSkill Building

12:05 PM – 12:35 PM EDT

Solutions Circle: Transparent, Translucent, and Opaque: How Global Health Authorities Make Information Publicly Accessible

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Seattle Genetics

Solutions CircleSkill Building

12:15 PM – 12:40 PM EDT

Sponsored Presentation: Managing regulatory change

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – IQVIA

Presented by

12:15 PM – 12:40 PM EDT

Sponsored Presentation: The 80/20 Rule: How Digital Transformation & AI Are Changing Regulatory Intelligence

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – Moderna

Presented By

12:15 PM – 12:40 PM EDT

Sponsored Presentation: Unlocking the Power of Retrospective PMCF Studies for EU MDR Compliance

Location/Room: Exhibit Hall: Discover! Stage (Booth 123)

Speaker: – RQM+

Presented by

12:30 PM – 1:00 PM EDT

RAPS BOD Roundtable: I Am Regulatory

Location/Room: RAPS Central (Exhibit Hall: Booth #610)

Guest Speaker: – MEDIcept

Guest Speaker: – NDA Partners

12:45 PM – 1:10 PM EDT

Sponsored Presentation: Global Medical Device UDI Status and How to Best Manage Diverse Compliance Rules

Location/Room: Exhibit Hall: Ignite! Stage (Booth 623)

Speaker: – LexisNexis Reed Tech

Presented by

12:45 PM – 1:10 PM EDT

Sponsored Presentation: The Future of Change Management for Cloud-Based AI/ML Medical Software

Location/Room: Exhibit Hall: Spark! Stage (Booth 323)

Speaker: – Ketryx Corporation

Presented by

12:45 PM – 1:15 PM EDT

Solutions Circle: Notified Bodies: IVDR implementation Ask me Anything

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – mi-CE consultancy

Facilitator: – NSAI

Facilitator: – TÜV SÜD America Inc.

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters

12:45 PM – 1:15 PM EDT

RAPS Store Stage: Meet the Authors - Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective

Location/Room: RAPS Store Stage (Level 2 Registration Foyer)

Speaker: – IAA Consulting LLC

RAPS Store Stage

12:45 PM – 1:15 PM EDT

Solutions Circle: Using Situational Leadership to Manage Yourself and Others

Location/Room: Exhibit Hall: Solutions Circles

Facilitator: – Quality and Regulatory Expert Partners, LLC

Solutions CircleSkill Building

12:45 PM – 1:45 PM EDT

RAPS Fellows Speed Mentoring at Career Central (Sign-up Required)

Location/Room: Exhibit Hall: Career Central (Booth 633)

Networking Opportunity

1:15 PM – 1:45 PM EDT

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

Location/Room: Exhibit Hall: Career Central (Booth 633)

Speaker: – RAPS

Speaker:

Career Central Stage

2:00 PM – 3:00 PM EDT

Biosimilar Regulatory Standards in the ICH Regions: Implications for Global Biosimilar Development

Location/Room: 513D

Presenter: – Allucent

Presenter: – Amgen

Presenter: – Allucent

Presenter (Remote): – European Medicines Agency (EMA)

Biopharmaceuticals (includes Biologics and Drugs)

2:00 PM – 3:00 PM EDT

Health Authority Forum: Health Canada

Location/Room: 513F

Panelist: – Health Canada

Health Authority Forum

2:00 PM – 3:00 PM EDT

Importance of Building Relationships with Health Authorities: Case Study for NDA Review of Orphan Product

Location/Room: 510B

Presenter: – Annexon Biosciences

Presenter: – US Food and Drug Administration

Presenter: – Alexion, AstraZeneca Rare Disease

Skill Building

2:00 PM – 3:00 PM EDT

IVDR Transition and Implementation: What Have We Learned from the MDR?

Location/Room: 511F

Session Leader: – BSI Group The Netherlands B.V.

Presenter:

Presenter: – Axon Lawyers

Devices (includes Medical Devices and In Vitro Diagnostics)

2:00 PM – 3:00 PM EDT

Pediatric Drug Development: Failure is not an Option

Location/Room: 513B

Presenter: – khhconsulting

Presenter: – IAA Consulting LLC

Presenter: – Planning Committee Chair Convergence 2023

Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters

2:00 PM – 3:00 PM EDT

Strategies to Leverage Patient Preference and Perspective to Support Development of New Drugs and Indications

Location/Room: 511D

Session Leader: – Bayer Pharmaceuticals

Presenter: – Organon

Moderator: – Bayer

Biopharmaceuticals (includes Biologics and Drugs)

2:00 PM – 3:00 PM EDT

Tackling a Whirlwind of Uncertainties: Lessons Learned on UK Market Access

Location/Room: 510A

Session Leader: – Qserve Group BV

Presenter: – SGS North America Inc.

Presenter: – ABHI

Devices (includes Medical Devices and In Vitro Diagnostics)

2:00 PM – 3:00 PM EDT

Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?

Location/Room: 511E

Moderator: – mi-CE consultancy

Moderator: – TÜV SÜD

Presenter: – TUV Sud GmbH

Presenter: – NSAI

Presenter: – GMED Certification Division

Presenter: – DEKRA

Devices (includes Medical Devices and In Vitro Diagnostics)

3:00 PM – 3:30 PM EDT

Coffee & Refreshment Break

Location/Room: Level 5 Foyer

Networking Opportunity

3:30 PM – 4:30 PM EDT

Live LinkedIn Feedback Session

Location/Room: RAPS Store Stage (Level 2 Registration Foyer)

Presenter: – Elemed

Skill Building

3:30 PM – 4:30 PM EDT

Navigating the Unique Complexities of CMC Challenges for Cell Therapies

Location/Room: 511F

Session Leader: – Takeda Pharmaceuticals

Presenter: – Obsidian Therapuetics

Presenter: – Takeda Pharmaceuticals

Presenter: – Allucent

Biopharmaceuticals (includes Biologics and Drugs)

3:30 PM – 4:30 PM EDT

Is Animal Testing Really No Longer Needed for Drug Development?

Location/Room: 513D

Session Leader: – KC Biopharmaceutical Consulting

Presenter (Remote): – Food and Drug Administration

Presenter (Remote): – NETRI

Presenter: – Pharnext

Biopharmaceuticals (includes Biologics and Drugs)

3:30 PM – 4:30 PM EDT

Overview of Select PDUFA VII Innovative Meeting Programs

Location/Room: 510B

Session Leader: – US Food and Drug Administration

Presenter: – US Food and Drug Administration

Moderator: – Alexion, AstraZeneca Rare Disease

Biopharmaceuticals (includes Biologics and Drugs)

3:30 PM – 4:30 PM EDT

Servicing Medical Devices – What Parts or Components SIGNIFICANTLY Change the Performance or Safety (Art 23)

Location/Room: 510A

Moderator: – Qserve Group

Presenter: – Elekta

Presenter: – SGS North America Inc.

Devices (includes Medical Devices and In Vitro Diagnostics)

3:30 PM – 4:30 PM EDT

The Art of Submission Planning: From Strategy to Filing

Location/Room: 513F

Session Leader: – Biogen

Skill Building

3:30 PM – 4:30 PM EDT

The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions

Location/Room: 511E

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

Presenter (Remote): – FDA

Presenter: – DuVal & Associates, P.A.

Devices (includes Medical Devices and In Vitro Diagnostics)Conversation Starters

3:30 PM – 4:30 PM EDT

The Inflation Reduction Act and Beyond: Impacts of the Evolving Reimbursement Landscape on Drug Development

Location/Room: 511D

Session Leader: – Mallinckrodt

Presenter: – Model N

Moderator: – QuidelOrtho

Biopharmaceuticals (includes Biologics and Drugs)

3:30 PM – 4:30 PM EDT

Understand the Evolving Role of Real World Evidence

Location/Room: 513B

Moderator: – Boston Scientific

Presenter (Remote): – US Food and Drug Administration

Presenter: – Johnson & Johnson MedTech

Speaker: – TÜV SÜD Medical Health Services

Speaker: – Medtronic Endoscopy

Devices (includes Medical Devices and In Vitro Diagnostics)

4:45 PM – 5:45 PM EDT

Companion Diagnostics: Overview of the IVDR Requirements and the EMA Consultation Process

Location/Room: 511E

Presenter: – BSI

Presenter: – European Medicines Agency

Presenter: – TÜV SÜD

Presenter: – ARUP Laboratories

Moderator: – TÜV SÜD

Devices (includes Medical Devices and In Vitro Diagnostics)

4:45 PM – 5:45 PM EDT

Challenges & Potential Global Convergence of the Regulatory Approval Process for Complex Generic Drugs

Location/Room: 510A

Session Leader: – Teva Pharmaceuticals

Presenter: – United States Pharmacopeia

Biopharmaceuticals (includes Biologics and Drugs)

4:45 PM – 5:45 PM EDT

Enabling Global Regulatory Environments to Deliver Better Self Care Interventions

Location/Room: 511D

Presenter: – Consumer Health Products Association

Presenter: – Bayer

Presenter:

Presenter: – Haleon Canada

Biopharmaceuticals (includes Biologics and Drugs)

4:45 PM – 5:45 PM EDT

Financial Acumen for Regulatory Affairs

Location/Room: 513F

Session Leader: – Thermo Fisher Scientific

Presenter: – Regulatory Affairs Professionals Society (RAPS)

Presenter: – UpToDate, Inc.

Skill Building

4:45 PM – 5:45 PM EDT

International Regulator Forum

Location/Room: 510B

Moderator: – Veeva Systems

Presenter: – Saudi Food and Drug Authority

Presenter (Remote):

Presenter: – Emergo by UL

Health Authority Forum

4:45 PM – 5:45 PM EDT

Predetermined Change Control Plans (PCCPS) are Now Codified in FDORA - What should you do?

Location/Room: 511F

Session Leader: – RQM+

Presenter: – RQM Plus

Devices (includes Medical Devices and In Vitro Diagnostics)

4:45 PM – 5:45 PM EDT

Regulatory Collaboration Through Cloud Platforms

Location/Room: 513D

Session Leader: – Bayer Pharmaceuticals

Presenter: – Janssen

Presenter (Remote): – FDA Center for Biologics Evaluation and Research

Presenter: – Accumulus Synergy

Biopharmaceuticals (includes Biologics and Drugs)

4:45 PM – 5:45 PM EDT

Streamlining Conformity Assessment in Medical Device Review: the FDA's ASCA Program

Location/Room: 513B

Moderator: – MEDIcept

Presenter: – US Food and Drug Administration

Devices (includes Medical Devices and In Vitro Diagnostics)

6:30 PM – 9:30 PM EDT

SOLD OUT - RAPS Farewell Jazz Soirée: Toasting the Future Together

Location/Room: Level 7

Networking Opportunity

Sponsored By