Human Factors Engineering and Usability Studies Congress

Improving User Experience and Regulatory Success through Innovative Designs of Medical Devices, Combination Products, and IFUs

December 7-8, 2020

San Diego, CA

Event Overview

The Human Factors Engineering & Usability Studies Congress is the only event specifically focused on the needs of medical device and combination product professionals responsible for avoiding use errors and medication errors while building a positive user experience. As your combination product matures, are you ready to address more involved questions of practical design, troubleshooting, and answering involved questions from regulators? This unique event will empower HF professionals to grow more confident in their skills, guide their teams toward the right insource/outsource decisions, and set new strategies for device software.

Hilton East Brunswick


3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

About the Chairperson


Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.

Featured Speakers


Craig Lipset

Head of Clinical Innovation


Jeff Kingsley

Chief Executive Officer
IACT Health 


Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice


Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Why Attend?

  1. Latest updates on domestic and international regulatory developments
  2. Ideal metrics for judging the ROI in human factors engineering and usability testing
  3. Innovative methods for selecting the best comparator devices and study designs
  4. Detailed insight on the design, testing, updating, and cybersecurity precautions required for medical device software and apps
  5. Unequaled access and networking opportunities with the life science industry’s leaders in usability testing

Who is Attending?

This conference is designed for senior leaders and executives in pharmaceutical, biotech, and medical device companies responsible for:

  • Human Factors / Human Factors Engineer
  • Usability
  • User Experience / User Interface / UX / UI
  • Patient Experience
  • Customer Experience
  • Medical Device
  • Combination Products
  • Device Development / Device Technology
  • Labeling
  • Packaging
  • Instrumentation
  • Design Assurance Engineer
  • Product Development
  • Device Design
  • Industrial Design
  • Design Controls
  • Wearables
  • Mobility
  • Software Engineering
  • Quality / Quality Control / Quality Assurance / Quality Engineer


October 19th, 2020 | Day 1

8:00 AM - 9:00 AM

Registration & Continental Breakfast

9:00 AM - 9:15 AM

Conference Opening Remarks

9:15 AM - 10:00 AM

Paper to Hybrid to eTMF – Best Practices for Selecting, Implementing, Transitioning and Assuring Compliance from Day One

Maha Saad, Ph.D., MBA - Americas Pharmacovigilance Head, Bioresearch Quality and Compliance, Quality Assurance

10:00 AM - 10:45 AM

Moving Toward a Risk-based eTMF Operating Model

Laura Naranjo - Associate Director, TMF Operations

10:45 AM - 11:00 AM

Morning Networking Break

11:00 AM - 12:00 PM

Using Metrics to Optimize Business Decisions


12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 1:45 PM

Sponsor Opportunity

1:45 PM - 2:45 PM

TMF Inspection Readiness

2:45 PM - 3:00 PM

Afternoon Networking Break

3:00 PM - 4:00 PM

Best Practices for Compliant eTMF Archiving


4:00 PM - 4:45 PM

TMF Governance

4:45 PM - 5:00 PM

Day 1 Closing Remarks



Oscar Segurado

ASC Therapeutics

Chief Medical Officer


Judy Hsiung

Arena Pharmaceuticals

Vice President Safety & Pharmacovigilance


Israel Gutierrez

Geron Corporation

Vice President, Pharmacovigilance and Drug Safety


Joan A. Chambers

The Center for Information & Study on Clinical Research Participation (CISCRP)

Senior Director, Marketing & Outreach


Michael Forstner


Senior Vice President and Head of Pharmacoepidemiology and Risk Management


Sheila Bose

SB Lifesciences Consulting, Inc



Christine Von Raesfeld

More Than Lupus

Patient Advocate and Board Member


Angela Ramirez Holmes

Cal Rare




Super Early Bird

Conference Only


Conference + Workshop


Register by 9/11/20

Early Bird

Conference Only


Conference + Workshop


Register by 10/9/20


Conference Only


Conference + Workshop


Register before event


Conference Only


Conference + Workshop


Register at event

Register 2 Attendees, Get 1 Complimentary Registration*!

Interested in sending groups of 7 or more? Contact us directly for pricing.



Contact Amy Chapman at (561) 571-7687




Why Become Board Certified in Medical Affairs?


Certification is becoming an important factor in the healthcare industry in general. A survey of over 1000 key opinion leaders (KOLs) found that over 90% preferred medical affairs professionals who had a Board Certified Medical Affairs Specialist (BCMAS) designation.

Several pharmaceutical companies also look at certification as a way to assess whether an individual possesses the skills and knowledge required for successful performance in a medical affairs role. Why are companies looking for this assurance? They want to hire the best of the best. By becoming board certified in your field of expertise, and by maintaining BCMAS, you are saying that you:

  • Have met standards that have been established and verified by a credible, accrediting body.
  • Are dedicated to maintaining quality of excellence in your profession.

These are powerful statements that speak volumes about you as a professional and the company or organization you represent. Board certification demonstrates that you are committed to your profession and that you want to continue to learn and grow.
Studies have shown that individuals who are certified in their field have higher salaries and better promotion opportunities.

Top 5 Reasons Why You Should Certify with the ACMA:

  1. Accredited: The ACMA is recognized nationally & internationally as a true mark of quality and excellence in the pharmaceutical industry for medical affairs professionals. The ACMA is accredited by the International Association for Continuing Education & Training (ANSI/IACET) which is the gold standard for certification & training around the world. Our program is administered and analyzed using the highest industry standards and state-of-the-art psychometric methodologies.
  2. Distinguish Yourself: Because ACMA offers multiple but related certificates, you can more readily become certified in more than one specialty, making you more valuable and marketable in the field.
  3. Go International: ACMA certification is widely accepted throughout the US as well as internationally with 25% of BCMAS graduates coming from outside the US.
  4. Expand Your Network: Once certified by ACMA you automatically become a member of the 75,000+ strong ACMA organization and gain access to a multitude of benefits, including discounts on continuing education, leadership opportunities, and access to a mentor to help you get ahead.
  5. Be on the cutting edge: ACMA board certification in medical affairs is the future of the life sciences and pharmaceutical industry.

Interested in BCMAS?

By attending any DGE/ACMA conference, receive 10% off of BCMAS registration.

Already BCMAS Certified? Receive 10% off your conference registration!