Convergence Overview

RAPS Convergence provides regulatory professionals key regulatory knowledge and resources on medical devices, IVDs and biopharma to help you successfully navigate today’s regulatory landscape.

What’s New for 2022

This year’s conference will be better than ever, with exciting new enhancements for new and returning faces.

New Learning formats

Break away from traditional learning! New ways to learn and interact with others will promote collaboration, networking and idea-sharing.

Honoring Excellence: RAPS 2022 Awards Celebration

Celebrate and thank regulatory leaders—Fellows, RAC holders, volunteers and award winners—for their contributions to RAPS and the profession at large. (Invitation only)

Catch the Game

Join your colleagues for a fun-filled night at Chase Field, home of the Arizona Diamondbacks. Watch the Diamondbacks take on the L.A. Dodgers from a private RAPS party area with amazing views of the field, food, drinks and great company! (Separate purchase required)

Less is Best

Both RAPS and the city of Phoenix are all about being resourceful and sustainable. This means reducing paper usage and waste throughout the event (check out the eco-friendly initiatives of the Phoenix Convention Center)

Career Central

Stop by for resume reviews, career counseling, professional headshot lounge, meeting spaces and a professional development theater.

Convergence 2022 Closing Party

Celebrate your Convergence experience on Tuesday night after the conclusion of the conference. Leave the outside world behind and immerse yourself in the interactive and hands-on fun of the Arizona Science Center. Admission is included with full conference registration.

2022 EDUCATIONAL TOPICS

Biopharmaceuticals (includes Biologics and Drugs)

Accelerating drug development and approval through pilot programs and initiatives
Advertising & Promotion and Labeling
Biosimilars
CMC & Quality
Combination Products
Expanded Access/Compassionate Use/Right-to-Try
Expedited Designations and Pathways
Generic Drug Development and Approval
Harmonization Efforts
Vaccines
Innovative Technologies and Platforms
Orphan Drugs and Rare Diseases
OTCs
Pharmacovigilance, Risk Evaluation and Mitigation Strategies
Recent Developments and Impact of the EU Legislative/Policy Environment
Recent Developments and Impact of the US Legislative/Policy Environment
Recent Developments in Other Geographical Regions Beyond EU and US
Real-World Evidence to Support Regulatory Decision-Making

Skill Building

Career Transitions
Crisis Management
Incorporating the Patient Perspective into the Regulatory Process
Leadership Skills
Leadership
Leveraging AI and Other Innovative Tools
Negotiation and Communication Skills
Preparing for Health Authority Interactions (meetings/scientific advice, advisory committees)
Regulatory Policy and Trends
Regulatory Strategy/Global Regulatory Planning
Other

In Vitro Diagnostics

Companion Diagnostics and Personalized Medicine
Emerging Standard Developments
Advertising & Promotion and Labeling
Medical Device Single Audit Program (MDSAP)
Performance Evaluation and Clinical Evidence
Recent Developments in EU Regulations (MDR and IVDR)
Recent Developments in IVDs
Recent Developments in LDTs

Medical Devices

Advertising, Promotion and Labeling
Clinical Evaluation
Combination Products
DeNovo Process
Digital Health/Software as a Medical Device/Mobile Apps and e-Labeling/Wearables
Emerging Standard Developments
Global Supply Chain Compliance
Harmonization/ IMDRF/AHWP
Human Factors Studies/Usability Engineering
Medical Device Single Audit Program (MDSAP)
Modeling and Simulation
Pediatric Medical Devices
Postmarketing Clinical Follow-Up (PMCF)
Preclinical Studies
Real-World Evidence to Support Regulatory Decision-Making
Recalls
Recent Developments in 510(k)
Recent Developments in EU Regulations
Recent Developments in Other Geographical Regions Beyond EU and US
Recent Developments in US Regulations
Regulatory Framework to Support Innovation
Risk management
Safety/Adverse Event Reporting

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

Preconference Workshop

Biopharmaceuticals
Drugs
In Vitro Diagnostics
Medical Devices

Schedule at-a-Glance

Regulatory Professionals’ Favorites

We’re bringing back some of your favorite activities to inspire, enlighten and encourage you to be your best!

Solutions Circles

These popular roundtables gather regulatory professionals to discuss and brainstorm with the highest form of collaboration in mind—taking the knowledge collected throughout Convergence and applying it to real-world situations. Bounce ideas off your colleagues. Examine regulatory challenges. Create and re-create learning structured by those who know the field best.

Meet the Authors

Hear directly from authors elaborating on the topics covered in some of RAPS’ most popular publications in an intimate forum where attendees can ask questions and share personal experiences.