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Browse by Technical Domains

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.

Browse by Technical Domains

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Business Acumen

Leadership

Other

Post approval/Post Market

Product Development and Registration

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: – BSI Group

Presenter: – DNV Product Assurance AS

Presenter: – National Standards Authority of Ireland

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Monday, Oct 2nd

8:30 AM – 4:00 PM EDT

What are the Requirements for an IND Submission?

Proficiency: Foundational/ Operational/ Novice

Workshop Leader: – HMC-Regulation

Presenter: – Synthego Corporation

Presenter: – Amplicore Inc

Preconference WorkshopBiopharmaceuticals (includes Biologics and Drugs)

Tuesday, Oct 3rd

8:30 AM – 4:00 PM EDT

IVDR Technical Documentation Pre-conference Workshop

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)

Wednesday, Oct 4th

10:45 AM – 11:15 AM EDT

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

Facilitator: – 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: – NNIT

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

11:25 AM – 11:55 AM EDT

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

Facilitator: – Roche

Facilitator: – Merck KGaA

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: – 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: – 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: – Item Alignment Inc.

Presenter: – 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: – Annexon Biosciences

Presenter: – US Food and Drug Administration

Presenter: – Alexion, AstraZeneca Rare Disease

Skill Building

Thursday, Oct 5th

2:00 PM – 3:00 PM EDT

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

Session Leader: – Qserve Group BV

Presenter: – SGS North America Inc.

Presenter: – ABHI

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

4:45 PM – 5:45 PM EDT

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

Moderator: – MEDIcept

Presenter: – US Food and Drug Administration

Devices (includes Medical Devices and In Vitro Diagnostics)

Regulatory Frameworks and Strategy

Monday, Oct 2nd

8:30 AM – 4:00 PM EDT

Communication Toolkit for a Successful Regulatory Compliance Strategy

Presenter: – nexialist

Presenter: – GMED North America

Preconference WorkshopDevices (includes Medical Devices and In Vitro Diagnostics)

Tuesday, Oct 3rd

8:30 AM – 4:00 PM EDT

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

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)

Tuesday, Oct 3rd

8:30 AM – 4:00 PM EDT

PRRC – A New EU Requirement

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)

Wednesday, Oct 4th

8:00 AM – 9:15 AM EDT

Unlocking Opportunities for Entry-Level Positions in Regulatory Affairs

Moderator: – Alexion, AstraZeneca Rare Disease

Presenter:

Presenter: – Network Partners Group

Presenter: – University of Georgia

Presenter: – Elemed

Presenter: – RAPS

Skill Building

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: – 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: – Regweb Consulting Services Inc.

Solutions CircleBiopharmaceuticals (includes Biologics and Drugs)

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: – Pharnext

Facilitator: – CMC-RX Consulting

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: – 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: – 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: – MEDIcept

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

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: – Abbott Laboratories

Presenter: – Abbott Laboratories

Presenter: – Axon Lawyers

Devices (includes Medical Devices and In Vitro Diagnostics)

Wednesday, Oct 4th

2:00 PM – 3:00 PM EDT

FDA Expectations for using Digital Tools in Decentralized Clinical Trials

Session Leader: – EMD Serono

Presenter: – Novo Nordisk

Presenter (Remote): – FDA

Presenter (Remote): – US FDA

Biopharmaceuticals (includes Biologics and Drugs)Conversation Starters

Wednesday, Oct 4th

2:00 PM – 3:00 PM EDT

Transforming Patient Engagement in Medical Technologies' Evolving Regulatory Landscape

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)

Wednesday, Oct 4th

2:00 PM – 3:00 PM EDT

UDI & Global Supply Chain Compliance

Session Leader: – Veeva MedTech

Presenter: – 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: – 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)

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: – POLITICO's AgencyIQ

Moderator: – Veeva Systems

Presenter: – 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: – 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)

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: – 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)

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: – 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)

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: – Moderna

Biopharmaceuticals (includes Biologics and Drugs)

Wednesday, Oct 4th

4:45 PM – 5:45 PM EDT

When to “Factor” in Human Factors

Presenter: – Agilis by Kymanox

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

8:00 AM – 9:15 AM EDT

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

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)

Thursday, Oct 5th

8:00 AM – 9:15 AM EDT

Medical Device Cybersecurity: Planning a Global Strategy

Session Leader: – MEDSEC

Presenter (Remote): – 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: – BSI Group The Netherlands B.V.

Presenter:

Presenter: – 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: – khhconsulting

Presenter: – IAA Consulting LLC

Presenter: – 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: – 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)

Thursday, Oct 5th

3:30 PM – 4:30 PM EDT

The Art of Submission Planning: From Strategy to Filing

Session Leader: – Biogen

Skill Building

Thursday, Oct 5th

4:45 PM – 5:45 PM EDT

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

Presenter: – BSI

Presenter: – European Medicines Agency

Presenter: – TÜV SÜD

Presenter: – ARUP Laboratories

Moderator: – TÜV SÜD

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

4:45 PM – 5:45 PM EDT

Enabling Global Regulatory Environments to Deliver Better Self Care Interventions

Presenter: – Consumer Health Products Association

Presenter: – Bayer

Presenter:

Presenter: – 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: – RQM+

Presenter: – RQM Plus

Devices (includes Medical Devices and In Vitro Diagnostics)

Thursday, Oct 5th

4:45 PM – 5:45 PM EDT

Regulatory Collaboration Through Cloud Platforms

Session Leader: – Bayer Pharmaceuticals

Presenter: – Janssen

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

Presenter: – Accumulus Synergy

Biopharmaceuticals (includes Biologics and Drugs)

Scientific and Health Concepts