Join the brightest minds in regulatory at the annual Regulatory Convergence.

See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators.
This is where it all comes together.


WHY ATTEND?

Thousands of your peers from all over the globe gather annually for Convergence. Chat with your boss about the value of the conference by sharing these top 10 reasons why you should attend. Download this customizable letter and personalize with your details to help your boss say “yes!”

“I would encourage people to come to Convergence because of the great, broad education—more than you’re going to get online unless you are searching tons of websites. All of the great input about what is going on is all right here. It’s a great value added.”
–Loren Walkington, RAC, program manager, clinical quality, Cardinal Health

“I love coming to Convergence to meet people from all walks of life. It’s a good place for knowledge transfer and to learn about new technologies in the market.”
–Trilochan Das, senior QA and regulatory affairs specialist, MiMedx, RAPS Texas Chapter Chair

“If someone is serious about regulatory affairs, Convergence is a great place to learn more about the new things that are happening at FDA and ministries of health around the world. It’s a great place to network and to meet other people who enjoy learning the same thing as you.”
–Grace Hong, senior regulatory specialist, Medtronic Inc.

ATTENDEE INFO

At RAPS we live and breathe regulatory. The annual Regulatory Convergence is designed specifically for you, and addresses all things relevant to our dynamic profession. Join us to experience a conference that includes knowledge sharing, education and training from some of the best minds in the business.

CONVERGENCE APP

The RAPS Events app lets you build your agenda, find your way around, interact with the speakers during their presentations, network with other attendees and earn points to be leader of the leaderboard at Convergence. The app will be available closer to the conference.

iOS in the Apple Store Android in Google Play HTML5 for all other devices, including laptops

RAPS CENTRAL

Sunday, 10 September, 6:00–7:30 pm
Monday, 11 September, 10:00 am–4:00 pm
Tuesday, 12 September, 10:00 am–4:00 pm

Visit RAPS Central in the Exhibit Hall. This is your go-to place for RAPS membership information, volunteer opportunities, up-to-the-minute news and information, updates on RAPS products and services and to purchase the publications you’ve been looking for.

The RAPS Store at RAPS Central is filled with must-have regulatory publications and this year’s newest titles.

 

CONVERSATIONS THAT MATTER

Monday, 11 September, 7:30–8:15 am │ 3:00–3:45 pm  
Tuesday, 12 September, 7:30–8:15 am │ 3:00–3:45 pm  

Join RAPS Fellows and senior regulatory professionals for informal discussions on key challenges facing today’s regulatory professionals. These sessions are not recorded and no slides will be presented. Come prepared to ask your questions and share your personal insights. Each session is open to everyone at all career levels, but seating is limited and is managed on a first come, first served basis.

GRAB AND GO NETWORKING

Monday, 11 September, 12:00–1:15 pm 
Tuesday, 12 September, 12:00–1:15 pm

Enjoy lunch while connecting with regulatory professionals from around the world. 

    • Enjoy a lunch session: Sponsored Education Session (Exhibit Hall)
    • Network indoors in the Exhibit Hall

RAC MINI-SESSIONS

Monday, 11 September, 3:00–3:45 pm
Tuesday, 12 September, 3:00–3:45 pm

Talk with members of the Regulatory Affairs Certification Board and RAC holders about where the RAC credential can take your career. Whether you’re wondering if you’re eligible to take the exam or building a study plan, these open discussions are a great way to get your questions answered.

DINE AROUNDS

Monday, 11 September, 6:00 pm

This popular dining out event is a great opportunity to spend quality time with friends and colleagues outside the convention center and sample some local cuisine.

CLOSING CELEBRATION

Tuesday, 12 September, 5:30–7:00 pm 

AGENDA

PRECONFERENCE WORKSHOPS SCHEDULE AT A GLANCE

SATURDAY, 9 SEPTEMBER
8:00 am–5:00 pm

    • Workshop Registration

8:00–9:00 am

    • Workshop Continental Breakfast

9:00 am–5:00 pm

    • Regulatory Strategy Forum for Medical Devices (Two-Day Workshop)
    • Regulatory Strategy Forum for Biologics (Two-Day Workshop)
    • Peeling the 510(k) Onion: From Fundamentals to Latest Trends (Two-Day Workshop)
    • Regulatory Leadership Institute (Two-Day Workshop)  
    • US Regulatory Essentials, Medical Devices and IVDs
    • EU Regulatory Essentials, Pharmaceuticals and Biologics

10:30–11:00 am

    • Beverage Break

12:30–1:30 pm

    • Lunch

3:00–3:30 pm

    • Beverage Break

SUNDAY, 10 SEPTEMBER
7:00–8:00 am

    • Workshop Registration

7:00–8:00 am

    • Workshop Continental Breakfast

8:00 am–4:00 pm

    • Regulatory Strategy Forum for Medical Devices (Two-Day Workshop)
    • Regulatory Strategy Forum for Biologics (Two-Day Workshop)
    • Peeling the 510(k) Onion: From Fundamentals to Latest Trends (Two-Day Workshop)
    • Regulatory Leadership Institute (Two-Day Workshop)
    • US Regulatory Essentials, Pharmaceuticals and Biologics
    • EU Regulatory Essentials, Medical Devices and IVDs: Transitioning From Current Directives Into Future Regulations
    • Regulatory Managers Boot Camp 
    • Regulatory Intelligence Master Class

10:00–10:30 am

    • Beverage Break

12:00–1:00 pm

    • Lunch

2:30–3:00 pm

    • Beverage Break

CONFERENCE SCHEDULE AT A GLANCE

SUNDAY, 10 SEPTEMBER
7:00 am–6:00 pm 

    • Registration Open

4:30–6:00 pm

    • Opening Plenary, Awards and Recognition

6:00–7:30 pm

    • Grand Opening of Exhibit Hall and Taste of DC 

6:00–7:30 pm 

    • RAPS Central Open

 

MONDAY, 11 SEPTEMBER
7:30 am–5:30 pm

    • Registration Open

7:30 am–8:30 am

    • Continental Breakfast

7:30 am–8:15 am

    • Sponsored Education Session
    • Conversations That Matter (Hosted by RAPS Fellows)

8:30 am–10:00 am

    • Concurrent Education Sessions

10:00 am–4:00 pm

    • RAPS Central Open

10:00 am–4:00 pm

    • Exhibit Hall Open

10:00–10:30 am

    • Beverage Break

10:30 am–12:00 pm

    • Concurrent Education Sessions

12:00–1:15 pm

    • Grab and Go Lunch and Open Exhibit Time

12:15–1:00 pm

    • Sponsored Education Session

1:15–2:45 pm

    • Concurrent Education Sessions

2:45–3:45 pm

    • Beverage Break in the Exhibit Hall

3:00–3:45 pm

    • Sponsored Education Session
    • RAC Mini-Session
    • Conversations that Matter (Hosted by RAPS Fellows)

4:00–5:30 pm

    • Concurrent Education Sessions

6:00–7:30 pm

    • Dine-Arounds

TUESDAY, 12 SEPTEMBER
7:30 am–5:30 pm

    • Registration Open

7:30 am–8:30 am

    • Continental Breakfast

7:30 am–8:15 am

    • Sponsored Education Session
    • Conversations That Matter (Hosted by RAPS Fellows)

8:30 am–10:00 am

    • Concurrent Education Sessions

10:00 am–4:00 pm

    • RAPS Central Open

10:00 am–4:00 pm

    • Exhibit Hall Open

10:00–10:30 am

    • Beverage Break

10:30 am–12:00 pm

    • Concurrent Education Sessions

12:00–1:15 pm

    • Grab and Go Lunch and Open Exhibit Time

12:15–1:00 pm

    • Sponsored Education Session

1:15–2:45 pm

    • Concurrent Education Sessions

2:45–3:45 pm

    • Beverage Break in the Exhibit Hall

3:00–3:45 pm

    • Sponsored Education Session
    • RAC Mini-Session
    • Conversations that Matter (Hosted by RAPS Fellows)

4:00–5:30 pm

    • Concurrent Education Sessions

5:30–7:00 pm

    • Closing Celebration

EDUCATION BY DESIGN
Engage in a variety of sessions that cover multiple areas of focus within the regulatory world. The following program tracks are available this year:

    • Workshops
    • Biopharmaceuticals
    • Conversations That Matter
    • Health-Related Foods
    • In Vitro Diagnostics
    • Medical Devices
    • Multiple Themes
    • RAC Mini-Sessions
    • Regulatory Business
    • Sponsored Education Sessions
    • Networking Events
    • Plenary Events

» Return to Top

PRECONFERENCE WORKSHOPS

WorkshopJoin us for a preconference warm up. Stretch your learning potential during our one-day and two-day preconference workshops. Each are designed as an opportunity for you to take an extensive, in-depth look into specific regulatory topics, organized by experts. Prepare to fully explore an area of interest and emerge with an advanced skillset and newly developed strategies.

Single-day workshops can be mixed and matched based on your preference to focus on a specific product area or region. Two-day workshops span Saturday and Sunday to allow in-depth coverage of specific topics or regions. They cannot be combined with the single-day workshop offerings.

SATURDAY, 9 SEPTEMBER

9:00 am–5:00 pm

Regulatory Strategy Forum for Medical Devices (Two-Day Workshop)

Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. In this two-day strategic workshop, experts will take you on a guided tour through the process of developing regulatory strategy. You will work in teams and learn how to maximize commercial opportunities for healthcare product manufacturers while minimizing company risk.

Regulatory Strategy Forum for Biologics (Two-Day Workshop)

Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. In this two-day strategic workshop, experts will take you on a guided tour through the process of developing regulatory strategy. You will work in teams and learn how to maximize commercial opportunities for healthcare product manufacturers while minimizing company risk.

Peeling the 510(k) Onion: From Fundamentals to Latest Topics (Two-Day Workshop)

This interactive, two-day workshop provides a robust baseline in the fundamentals of 510(k) submissions. The latest developments in the 510(k) environment will be reviewed with helpful tips on corresponding optimal regulatory strategy, when and how to contact FDA, and how to optimize opportunities for a predictable 510(k) review experience.

Regulatory Leadership Institute (Two-Day Workshop)

Take the next step in your career with expert-led leadership training with the Regulatory Leadership Institute. Facilitated by professional executive trainers, the Regulatory Leadership Institute immerses you in two fast-paced days of the skills you need to advance your career or step into a leadership role well-equipped and attuned to the challenges ahead.

EU Regulatory Essentials, Pharmaceuticals and Biologics

A comprehensive overview of EU regulatory affairs for pharmaceuticals and biologics, this workshop will benefit individuals who are new to the regulatory profession, changing product line/industry or preparing for the RAC EU examination. Regulations, directives and policies affecting Europe's regulatory system with specific issues and information addressing development considerations, clinical trials, marketing applications, pre- and postmarketing requirements will be covered.

US Regulatory Essentials, Medical Devices and IVDs

A comprehensive overview of US regulatory affairs for devices and IVDs, this workshop will benefit individuals who are new to the regulatory profession, changing product line/industry or preparing for the RAC US examination. Laws and policies affecting US regulation of devices and IVDs; an overview of the agency structures regulating these products; and advertising, labeling and promotional aspects, and postmarket, compliance and enforcement requirements will be covered.

SUNDAY, 10 SEPTEMBER

8:00 am–4:00 pm

Regulatory Strategy Forum for Medical Devices (Two-Day Workshop)

Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. In this two-day strategic workshop, experts will take you on a guided tour through the process of developing regulatory strategy. You will work in teams and learn how to maximize commercial opportunities for healthcare product manufacturers while minimizing company risk.

Regulatory Strategy Forum for Biologics (Two-Day Workshop)

Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. In this two-day strategic workshop, experts will take you on a guided tour through the process of developing regulatory strategy. You will work in teams and learn how to maximize commercial opportunities for healthcare product manufacturers while minimizing company risk.

Peeling the 510(k) Onion: From Fundamentals to Latest Topics (Two-Day Workshop)

This interactive, two-day workshop provides a robust baseline in the fundamentals of 510(k) submissions. The latest developments in the 510(k) environment will be reviewed with helpful tips on corresponding optimal regulatory strategy, when and how to contact FDA, and how to optimize opportunities for a predictable 510(k) review experience.

Regulatory Leadership Institute (Two-Day Workshop)

Take the next step in your career with expert-led leadership training with the Regulatory Leadership Institute. Facilitated by professional executive trainers, the Regulatory Leadership Institute immerses you in two fast-paced days of the skills you need to advance your career or step into a leadership role well-equipped and attuned to the challenges ahead.

EU Regulatory Essentials, Medical Devices and IVDs: Transitioning From Current Directives Into Future Regulations

Transition continues for medical devices and IVD from the current European Directives to new European Regulations. The Active Implantable Medical Device Directive (AIMDD) and Medical Device Directive (MDD) will merge into the new Medical Device Regulation (MDR). For the IVDs, the In Vitro Diagnostic Directive (IVDD) will be replaced by the In Vitro Diagnostic Regulation (IVDR). This preconference will divide into two tracks. Each track will reconfirm the essentials of the current directives, address the changes introduced by the regulations and provide inputs for planning a successful transition process. Experts will provide attendees with solid understanding of what remains the same, what changes and what are new requirements must be addressed.

US Regulatory Essentials, Pharmaceuticals and Biologics

A comprehensive overview of US regulatory affairs for biologics and pharmaceuticals, this workshop will benefit individuals who are new to the regulatory profession, changing product line/industry or preparing for the RAC US examination. Laws and policies affecting US regulation of biologics and pharmaceutical products; an overview of the agency structures regulating these products; and advertising, labeling and promotional aspects, and postmarket, compliance and enforcement requirements will be covered.

Regulatory Managers Boot Camp

Looking for a way to improve your communication, management or leadership skills for accelerated professional growth? Don’t miss this workshop, which will target key topics and practical information you can use to make immediate improvements in your ability to manage people, provide feedback, influence at all levels and lead with or without the title. Interactive case study sessions focus on scenarios you’re likely to face throughout your regulatory career.

TRAVEL

Join us for RAPS Regulatory Convergence at the Gaylord National Resort and Convention Center in National Harbor at the DC Waterfront.

Washington DC National Harbor

Gaylord National Resort and Convention Center
201 Waterfront Street
National Harbor, MD 20745

National Harbor is a unique destination in the DC area, designed to take full advantage of the most historic river in the country. On the banks of the Potomac, you will enjoy 350 acres that are home to the Gaylord National Resort and Convention Center, MGM National Harbor Resort, Tanger Outlets, tree-lined promenades, scores of shops and restaurants, a world-class marina, and the Capital Wheel—a 180-foot observation wheel with panoramic views of Washington, DC.

Hotel Information

RAPS has secured a discounted room block at the Gaylord National Resort and Convention Center. Please note to receive the discounted rate and RAPS benefits you must book through the RAPS hotel block. All RAPS events will take place at the Gaylord.

Rate: $264
Tax: 16% per night (6% state/10% occupancy)
Resort Fee: $18 per night
Tax: 6% state tax  

Resort fee include:

  • High-speed internet access in your guest room
  • Twenty-four hour access to the fitness center
  • Access to the indoor junior Olympic-sized pool
  • Local, toll-free and domestic long-distance phone calls
  • Two bottles of Aquafina® water per-room, per day
  • Newspaper available daily at Key Provisions
  • Valuable coupon booklet with savings at the resort and local area
  • Up to $10 complimentary dry cleaning, per day
  • Complimentary transportation on the National Harbor Circulator Bus with stops throughout the Harbor including Tanger Outlets, Harbor shops and restaurants, the Capital Wheel, and the MGM National Harbor Resort. Registered guest simply swipe their room key on the bus for this transportation service.

Reserve your hotel today.

Phone: +1 877 491 0468
Please reference the RAPS Convergence for the discounted rate.
Deadline date for discount: 19 August 2017

Getting There

Airports

Ronald Reagan Washington National Airport (DCA) 
Taxi: $20-25
Estimated Travel Time: 15 minutes
Estimated Cost for Super Shuttle: $18 

Washington Dulles International Airport (IAD)
Taxi: $80
Estimated Travel Time: 30 minutes
Estimated Cost for Super Shuttle: $44

 

Baltimore–Washington International Airport (BWI)
Taxi: $80
Estimated Travel Time: 50 minutes
Estimated Cost for Super Shuttle: $45

Driving

Driving Directions: https://www.nationalharbor.com/directions/

Parking Information
Gaylord National Resort and Convention Center
Self-Parking: $12 hourly, $30 daily
Valet: $43 daily

National Harbor has three covered parking garages strategically located close to attractions, hotels, shops and restaurants. St. George Garage is the closest to the Gaylord and about a 3-5-minute walk. We recommend that you pre-purchase parking using the link below.

Parking directions, rates and maps: http://parking.nationalharbor.com/

Daily parking: $18 (includes taxes and fees) 

Travel Alert

Occasionally, outside companies try to defraud conference attendees by offering deals or assistance with hotel or travel bookings. RAPS is not associated with any outside companies. Please do not provide any credit card or confidential information. Attendees should book with the hotel or airline service of their choice. 

If you have questions or need assistance, please contact marie.fredlake@conferencedirect.com.

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PRESENTER RESOURCES

Step 1: Review presenter requirements and benefits

Step 2: Confirm participation
Email Heather Wakefield at hwakefield@raps.org to confirm that you will participate as a presenter and agree to the requirements and benefits.

Step 3: Book hotel and travel 
See the Travel page for details.
RAPS will only book hotel accommodations and flights for health authority officials as required.

Step 4: Register as presenter
Please refer to your invitation from RAPS for instructions on how to register as a presenter. Please email Heather Wakefield at hwakefield@raps.org with any questions.

Step 5: Review guidelines, timeline and submit presentation

  • Download the PowerPoint Presentation Template (strongly encouraged but not required) and refer to the AV Specifications for Presentations and Equipment document.
  • Please refrain from biased and commercial references to individual companies, organizations or products.
  • Review RAPS' Speaker Tips video series.
  • 28 July Presenters will receive a separate notification from RAPS with the presentation submission link and a personalized login.
  • 28 July11 August Presenters email all PowerPoint presentations to session leader(s) for review. Session leaders to review presenter PowerPoint presentations prior to submission to RAPS to ensure fairbalanced educational content.
  • 11 August Submit presentation(s) to RAPS for conversion to premeeting handouts in a secure PDF format.
  • 11 August6 September Submission site remains open for uploading updated/revised presentations.
  • Week of 14 August PowerPoint presentation slides converted to a secure PDF format will be made available to conference attendees.

PowerPoint Presentation Template

Step 6: Check in on site
Speaker Ready Room
RAPS staff and a technician will be available to assist you with your presentation. You will be able to review, edit and preview your presentation as it will be displayed in your session room and you can prepare with other speakers and print documents related to your presentation.
We recommend you check in a minimum of 24 hours in advance of your session, but please make every effort to finalize your presentation for morning sessions by closing time the day prior or for afternoon sessions by 11:30 am on the day of your session.

Speaker Ready Room hours of operation:

  • Saturday, 9 September: 8:00 am - 5:00 pm
  • Sunday, 10 September: 7:00 am - 6:00 pm
  • Monday, 11 September: 7:30 am - 5:30 pm
  • Tuesday, 12 September: 7:30 am - 5:00 pm

Step 7: Earn RAC credits
If you hold the RAC credential, you are eligible for recertification credits as part of your participation in RAPS Regulatory Convergence. Presenters receive four hours of recertification credits per hour of instruction, and conference attendees can receive a maximum of 12 RAC recertification credits for attending the full program and six RAC recertification credits for attending each day of a workshop (per the Recertification Guide).

Exhibitors and Sponsors

The Regulatory Convergence is the premier event for access to 1,800+ regulatory professionals working in the medical device, pharmaceutical and biotech industries. Join us in the Exhibit Hall to meet this year’s exhibitors who, in addition to working in submission and compliance, play integral roles in every stage of the healthcare product lifecycle including development, distribution, marketing and postmarket surveillance.

Why Exhibit at Convergence

ACCESS TO TARGET AUDIENCE
RAPS Regulatory Convergence is an effective way to strengthen business relationships, create new sales leads, recruit regulatory talent and showcase your products and services to regulatory professionals representing every facet of the healthcare product regulatory community. At Convergence, more than 1,700 regulatory professionals gather.