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
 

Regulatory Professionals’ Favorites

 

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

 
Solutions Circles
 

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
 

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.


 

Convergence 2022 Planning Committee

 

A special thank you to the Convergence 2022 Planning Committee for making this year’s conference possible.

 
Committee Leaders
 
Kimberly Belsky
Kimberly Belsky
(Chair)
Executive Director, Reg Policy & Intel, AdPromo, and RegOps, Regulatory Affairs
Mallinckrodt Pharmaceuticals
Megha Deviprasad Iyer
Megha  Deviprasad Iyer
(Vice Chair)
Director, Global Strategic Regulatory Affairs
Thermo Fisher Scientific
Gert Bos
Gert Bos
(RAPS Board of Directors Representative)
Executive Director & Partner
Qserve China
 
Committee Members
 
Bassil Akra
Bassil Akra

Chief Executive Officer, Akra Team

João Duarte
João Duarte

Director, Chief of Staff & Regulatory Science, Alexion Pharmaceuticals

Linda McBride
Linda McBride

Biopharmaceuticals Consultant

George Serafin
George Serafin

Senior Managing Director, Fti Consulting

Katie Rivers
Katie Rivers

FDA Liaison, Project Manager, U.S. Food and Drug Administration

Lisa Baumhardt
Lisa Baumhardt

Senior Medical Device Regulation Expert, Hyman, Phelps & McNamara

Niedre Heckman
Niedre Heckman

Director, CMC and Devices/Combination Products, Global Reg. Affairs, Takeda

Erin Oliver
Erin Oliver

Head, US Regulatory Affairs, GlaxoSmithKline Consumer Healthcare

Chris Whalley
Chris Whalley

Associate Director, Regulatory Policy & Intelligence, Seagen

Sabine Haubenreisser
Sabine Haubenreisser

EMA Liaison, Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency

Francis Dekker
Francis Dekker

Senior Regulatory Affairs Manager, Thermofisher Scientific

Richard Jahn
Richard Jahn

Sr. Director Global Regulatory Policy & Intelligence, Global Product Development, Pfizer