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Browse by Knowledge Areas

The RAPS Regulatory Competency Framework is a one-of-a-kind tool to help you map your experience to align with your learning goals. Use this section of the navigation to browse Convergence sessions by framework levels, domains and knowledge areas to further enhance your learning goals. 

For full framework details, domain, and knowledge area definitions, visit https://www.raps.org/resources/regulatory-competency-framework.

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Application of Scientific and Clinical Advances

Wednesday, Oct 4th

8:00 AM - 9:15 AM EDT

Risk Management – The Importance of Lifecycle Traceability

Session Leader: Kimberly A. Trautman, MS – MEDIcept

Presenter: Brian Siroka – MEDIcept Inc.

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

4:45 PM - 5:45 PM EDT

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

Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials

Presenter: Sarah Bly – Worldwide Clinical Trials

Biopharmaceuticals (includes Biologics and Drugs)

Change Management

Thursday, Oct 5th

3:30 PM - 4:30 PM EDT

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

Moderator: Keith Morel, PhD – Qserve Group

Presenter: Leo Hovestadt – Elekta

Presenter: Balazs Bozsik – SGS North America Inc.

Devices (includes Medical Devices and In Vitro Diagnostics)

Communication

Thursday, Oct 5th

11:25 AM - 11:55 AM EDT

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

Facilitator: Yoshiko Stowell, PhD – Neuron23, Inc.

Facilitator: Susan E. Carino, FRAPS, MBA, MS, PMP, RAC, SSM – Integrated Project Management Company, Inc.

Solutions CircleSkill Building

Data Management and Analysis

Wednesday, Oct 4th

2:00 PM - 3:00 PM EDT

FDA Expectations for using Digital Tools in Decentralized Clinical Trials

Session Leader: Junyang Wang – EMD Serono

Presenter: Jill Lee, JD – Novo Nordisk

Presenter (Remote): Elizabeth Kunkoski, MS – FDA

Presenter (Remote): Andrew Potter, PhD – US FDA

Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters

Wednesday, Oct 4th

2:00 PM - 3:00 PM EDT

UDI & Global Supply Chain Compliance

Session Leader: Brian Scogland, MS, MBA – Veeva MedTech

Presenter: Jay Crowley, MS – USDM Life Sciences

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

3:30 PM - 4:30 PM EDT

Ensuring Patient Registries Support Regulatory Decision-Making

Presenter: David Hinds, MHS – BioMarin Pharmaceutical Inc.

Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency

Presenter: Mayss Naccache, MSc – World Federation of Hemophilia

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

Moderator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceuticals, Inc.

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

4:45 PM - 5:45 PM EDT

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

Session Leader: Matthias Fink, MD – Akra Team Inc.

Presenter: Tonia Jeiter, Dr. med. – TÜV SÜD Product Service GmbH

Presenter: Richard G. Holborow – BSI

Presenter: Christoph Ziskoven, MD – TÜV Rheinland LGA Products GmbH

Devices (includes Medical Devices and In Vitro Diagnostics)

Documentation

Wednesday, Oct 4th

11:25 AM - 11:55 AM EDT

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

Proficiency: Foundational/ Operational/ Novice

Facilitator: Cammilla Gomes – Roche

Facilitator: Pedro Franco, PhD, MSc, PharmD. – Merck KGaA

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

General

Monday, Oct 2nd

8:30 AM - 4:00 PM EDT

What are the Requirements for an IND Submission?

Workshop Leader: Hagit Marchaim, PhD MBA – HMC-Regulation

Presenter: Lina Jamis, MS – Synthego Corporation

Presenter: Tyler C. Vandivort, PhD, RAC, DABT – Amplicore Inc

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

Tuesday, Oct 3rd

8:30 AM - 4:00 PM EDT

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

Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency

Presenter: Karl-Heinz Huemer, MD, PhD – khhconsulting

Presenter: Maria Concepción Prieto Yerro, MD, PhD – Spanish Agency for Medicines and Medical Devices

Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency

Presenter: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority

Presenter (Remote): Matthias Dormeyer, MD – Granzer Regulatory Consulting & Services GmbH

Presenter: Daniela Drago, PhD, RAC, FRAPS – NDA Partners

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

Tuesday, Oct 3rd

8:30 AM - 4:00 PM EDT

PRRC – A New EU Requirement

Workshop Leader: Bassil Akra, phD – Akra Team GmbH

Presenter: Danielle Giroud, MSci – MD-CLINICALS SA

Presenter: Keith Morel, PhD – Qserve Group

Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS

Presenter: Erik R. Vollebregt – Axon Lawyers

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

8:00 AM - 9:15 AM EDT

Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs

Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease

Presenter: Brittany Caldwell

Presenter: Ritu Dhami – Network Partners Group

Presenter: Grace Gowda, M.Pharm., PhD, RAC – University of Georgia

Presenter: Elena Kyria – Elemed

Presenter: Brian Savoie – RAPS

Skill Building

Wednesday, Oct 4th

4:45 PM - 5:45 PM EDT

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

Session Leader: Paul A. Wardle, MA, MMath – Beacon Associates, LLC

Presenter: Danielle Terrell, PharmD, JD, MS, RAC U.S. – Food and Drug Administration

Presenter (Remote): Elisabeth Walther, PharmD, JD – US Food and Drug Administration

Presenter: Alfred Whitehead, MAs, MS – Klick Consulting

Moderator: Erin Oliver, MS, MBA, FRAPS – Haleon

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Oct 5th

12:05 PM - 12:35 PM EDT

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

Facilitator: Chris Whalley, cwhalley@seagen.com – Seattle Genetics

Solutions CircleSkill Building

Thursday, Oct 5th

4:45 PM - 5:45 PM EDT

Enabling Global Regulatory Environments to Deliver Better Self Care Interventions

Presenter: Jay E. Sirois, PhD – Consumer Health Products Association

Presenter: Joseph Chan, RPh – Bayer

Presenter: Gerry Harrington

Presenter: Amanda Wong, RAC – Haleon Canada

Biopharmaceuticals (includes Biologics and Drugs)

Thursday, Oct 5th

4:45 PM - 5:45 PM EDT

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

Session Leader: Nancy J. Morrison, RAC – RQM+

Presenter: Hrishikesh Gadagkar, PhD – RQM Plus

Devices (includes Medical Devices and In Vitro Diagnostics)

Industry-specific Knowledge

Wednesday, Oct 4th

3:30 PM - 4:30 PM EDT

The Future of Regulatory Affairs In An Everchanging World

Session Leader: Aman Khera, EMBA, FRAPS, FTOPRA – Worldwide Clinical Trials

Presenter: Linda Bowen, MSc, RAC, FRAPS – Seagen Inc.

Skill Building

Thursday, Oct 5th

12:05 PM - 12:35 PM EDT

Solutions Circle: The Journey to RAC!

Facilitator: Rani Maloney, MBA, PMP, RAC – Integrated Project Management

Facilitator: Gregory L. Palagi, PMP DASM CSM – Integrated Project Management, Inc.

Facilitator: Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS

Solutions CircleSkill Building

Leadership

Wednesday, Oct 4th

2:00 PM - 3:00 PM EDT

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

Session Leader: Monika McDole-Russell, MS, RAC – Medtronic Endoscopy

Moderator: Amra Racic – Veeva Systems

Skill Building

Thursday, Oct 5th

12:45 PM - 1:15 PM EDT

Solutions Circle: Using Situational Leadership to Manage Yourself and Others

Facilitator: Jacqueline Torfin – Quality and Regulatory Expert Partners, LLC

Solutions CircleSkill Building

Market Strategy

Wednesday, Oct 4th

2:00 PM - 3:00 PM EDT

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

Session Leader: Jennifer Ng Ain Kin – Abbott Laboratories

Presenter: Hillary VanderBand, MBA – Abbott Laboratories

Presenter: Erik R. Vollebregt – Axon Lawyers

Devices (includes Medical Devices and In Vitro Diagnostics)

Negotiation

Thursday, Oct 5th

8:00 AM - 9:15 AM EDT

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

Presenter: Derecka Alexander, MPH, DVM – American Association for the Advancement of Science/USDA

Presenter: Marcus S. Delatte, PhD – Allucent

Presenter: Owen McMaster, PhD – Food and Drug Administration

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

Process and Procedures

Wednesday, Oct 4th

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

Facilitator: Abhijit P. Pangu, M. Pharm, RAC – Pharnext

Facilitator: Myriam Triest, PhD – CMC-RX Consulting

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Thursday, Oct 5th

4:45 PM - 5:45 PM EDT

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

Presenter: Judith Prevoo – BSI

Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency

Presenter: James Hewitt – TÜV SÜD

Presenter: Chelsea Welch – ARUP Laboratories

Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD

Devices (includes Medical Devices and In Vitro Diagnostics)

Recordkeeping, Monitoring

Wednesday, Oct 4th

12:45 PM - 1:15 PM EDT

Solutions Circle: Annex XVI State of Play

Facilitator: Alexey Shiryaev, MD PhD – DNV Product Assurance AS

Presenter: jayanth K. Katta, PhD – BSI

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Regulatory Filing

Wednesday, Oct 4th

10:45 AM - 11:15 AM EDT

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

Facilitator: Robert L. Waterland, PhD – Certara Drug Development Solutions

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

11:25 AM - 11:55 AM EDT

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

Facilitator: Niels B. Leander, PhD – NNIT

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

12:45 PM - 1:15 PM EDT

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

Facilitator: Diane M. Ward, PhD – Qserve Group US

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

3:30 PM - 4:30 PM EDT

Industry Experience with Implementing ICH Q12 in US and Canada

Presenter: Jamie L. Robinson, RAC, MBA – Genentech, Inc.

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

4:45 PM - 5:45 PM EDT

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

Session Leader: Jeff Holzman – Item Alignment Inc.

Presenter: Jay Crowley, MS – USDM Life Sciences

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

2:00 PM - 3:00 PM EDT

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

Presenter: AJ Acker – Annexon Biosciences

Presenter: Kunal Kanani, PharmD, MBA – Annexon Biosciences

Presenter: Mary Jo Salerno, MS PT, MPH – US Food and Drug Administration

Presenter: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease

Skill Building

Thursday, Oct 5th

4:45 PM - 5:45 PM EDT

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

Moderator: Kimberly A. Trautman, MS – MEDIcept

Presenter: Gail M. Rodriguez, Ph.D. – US Food and Drug Administration

Presenter: Scott Colburn, MS, BSN – US Food and Drug Administration

Devices (includes Medical Devices and In Vitro Diagnostics)

Regulatory Guidance

Thursday, Oct 5th

2:00 PM - 3:00 PM EDT

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

Session Leader: Daniëlle Motta, MSc. – Qserve Group BV

Presenter: Balazs Bozsik – SGS North America Inc.

Presenter: Phil Brown – ABHI

Devices (includes Medical Devices and In Vitro Diagnostics)

Regulatory knowledge

Thursday, Oct 5th

3:30 PM - 4:30 PM EDT

Overview of Select PDUFA VII Innovative Meeting Programs

Session Leader: CHRISTOPHER EGELEBO, DHSc, MBA, MS, RAC, PMP, RN – US Food and Drug Administration

Presenter: Yvonne Knight, MS – US Food and Drug Administration

Presenter: Mary Jo Salerno, MS PT, MPH – US Food and Drug Administration

Moderator: Jethro E. Ekuta – Alexion, AstraZeneca Rare Disease

Biopharmaceuticals (includes Biologics and Drugs)

Regulatory Strategy Development

Monday, Oct 2nd

8:30 AM - 4:00 PM EDT

Communication Toolkit for a Successful Regulatory Compliance Strategy

Presenter: Corinne Delorme, MS, RAC – nexialist

Presenter: Vincent Castéras, PhD – nexialist

Presenter: Florianne Torset-Bonfillou, MS, RAC – GMED North America

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

10:45 AM - 11:15 AM EDT

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

Facilitator: Farhad Amiri, PhD, FAHA – Parexel International

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

10:45 AM - 11:15 AM EDT

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

Facilitator: Guriqbal Singh – Regweb Consulting Services Inc.

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

12:05 PM - 12:35 PM EDT

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

Facilitator: Lucy Tan, MBA – Abbott

Facilitator: Jenny Chan, MS, RAC, PMP – Abbott

Solutions CircleDevices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

12:05 PM - 12:35 PM EDT

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

Facilitator: Cham Williams, MS – IQVIA

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

12:45 PM - 1:15 PM EDT

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

Facilitator: Kimberly A. Trautman, MS – MEDIcept

Facilitator: Richelle Helman, RAC – MEDIcept

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

Wednesday, Oct 4th

2:00 PM - 3:00 PM EDT

Transforming Patient Engagement in Medical Technologies' Evolving Regulatory Landscape

Moderator: Renee Marie Mitchell, MT (ASCP), CLS (NCA) – Boston Scientific

Presenter: Scott Goates, PhD. – Abbott

Presenter: Korinne Jew, PhD – Medtronic

Presenter: Alexandra Massoud – Exact Sciences

Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

3:30 PM - 4:30 PM EDT

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

Presenter: Alexander Gaffney, MS, RAC – POLITICO's AgencyIQ

Moderator: Amra Racic – Veeva Systems

Presenter: Laura DiAngelo, MPH – POLITICO's AgencyIQ

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

4:45 PM - 5:45 PM EDT

Challenges in Implementation of IVDR Requirements for CDx Clinical Performance Studies

Moderator: Adriana Racolta, PhD, RAC – Seagen, Inc

Presenter: Iordanis Gravanis, MD, PhD – European Medicines Agency

Presenter: Christine Mayer-Nicolai, PhD – Merck KGaA, Darmstadt, Germany

Presenter: Mike Wierzba, PhD – GSK

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

Wednesday, Oct 4th

4:45 PM - 5:45 PM EDT

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

Presenter: Antonella Lozito, PharmD – Moderna

Presenter: Immo Zdrojewski – Moderna

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

4:45 PM - 5:45 PM EDT

When to “Factor” in Human Factors

Presenter: Rita Lin – Agilis by Kymanox

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

8:00 AM - 9:15 AM EDT

Medical Device Cybersecurity: Planning a Global Strategy

Session Leader: Michelle Lynn Jump, MS, MSRS, ISO/TC 215 convener, RAPS instructor – MEDSEC

Presenter (Remote): Suzanne Schwartz, MD, MBA – US FDA

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

2:00 PM - 3:00 PM EDT

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

Session Leader: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.

Presenter: Amélie Chollet

Presenter: Erik R. Vollebregt – Axon Lawyers

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

2:00 PM - 3:00 PM EDT

Pediatric Drug Development: Failure is not an Option

Presenter: Karl-Heinz Huemer, MD, PhD – khhconsulting

Presenter: Linda McBride, R.PH, RAC – IAA Consulting LLC

Presenter: Kimberly Belsky, MS, FRAPS – Planning Committee Chair Convergence 2023

Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters

Thursday, Oct 5th

2:00 PM - 3:00 PM EDT

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

Moderator: Anja Wiersma, PhD – mi-CE consultancy

Moderator: Sabina Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD

Presenter: Marta Carnielli, PharmD – TUV Sud GmbH

Presenter: Tom Patten – NSAI

Presenter: Catherine Holzmann – GMED Certification Division

Presenter: Azam Khorshidi – DEKRA

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

3:30 PM - 4:30 PM EDT

The Art of Submission Planning: From Strategy to Filing

Session Leader: Cassandra T. San Jose, MS-RA/QA, RAC, PMP, SPMC, CPM – Biogen

Skill Building

Thursday, Oct 5th

4:45 PM - 5:45 PM EDT

Regulatory Collaboration Through Cloud Platforms

Session Leader: Vada A. Perkins, MSc, MS, DRSc (c) – Bayer Pharmaceuticals

Presenter: Danielle Friend – Janssen

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

Presenter: Khushboo Sharma, MBA – Accumulus Synergy

Biopharmaceuticals (includes Biologics and Drugs)

Submission Management

Monday, Oct 2nd

8:30 AM - 4:00 PM EDT

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

Presenter: Purvi S. Patel, PhD, CEng, MIMechE – BSI Group

Presenter: Vishal Thakker, MEng – BSI Group

Presenter: Rachel Mead, BEng MIET – BSI Group

Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS

Presenter: Gareth Enright, MEng – National Standards Authority of Ireland

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, Oct 3rd

8:30 AM - 4:00 PM EDT

IVDR Technical Documentation Pre-conference Workshop

Presenter: Marta Carnielli, PharmD – TUV Sud GmbH

Presenter: Tom Patten – NSAI

Presenter: Catherine Holzmann – GMED Certification Division

Presenter: Alex Laan, Dipl.-Ing. – BSI Group The Netherlands B.V.

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)