2017 RAPS Regulatory Convergence by medical writing

A T T EN D EE IN F O

A G EN D A

W O R K S H O PS

T R A V EL

PR ES EN T ER S

EX H IB IT O R S & S PO N S O R S

R EG IS T ER

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.

R E G I S TE R N O W

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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.

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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.

S P R E A D TH E W O R D A B O U T # 2 0 1 7 R A P S

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.

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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-theminute 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.

TASTE OF NATIONAL HARBOR RECEPTION Sunday, 10 September, 6:00–7:30 pm Come enjoy some of the finest local fare, beer and wine while connecting with colleagues and PDFmyURL - online url to pdf conversion

exhibitors in a fun, relaxed environment inside the Exhibit Hall..

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 PDFmyURL - online url to pdf conversion

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.

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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 RECEPTION - Next Stop: Vancouver 2018 Tuesday, 12 September, 5:30â&#x20AC;&#x201C;6:30 pm

AGENDA

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PRECONFERENCE WORKSHOPS SCHEDULE AT A GLANCE Get the 2017 Convergence Matrix

SATURDAY

SATURDAY, 9 SEPTEMBER 8:00 am–5:00 pm Workshop Registration 8:00–9:00 am NETWORKING

Workshop Continental Breakfast

9:00 am–5:00 pm WORKSHOP

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

WORKSHOP

Regulatory Strategy Forum for Biologics (Two-Day Workshop)

WORKSHOP

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

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WORKSHOP

Regulatory Leadership Institute (Two-Day Workshop)

WORKSHOP

US Regulatory Essentials, Medical Devices and IVDs

WORKSHOP

EU Regulatory Essentials, Pharmaceuticals and Biologics

10:30–11:00 am NETWORKING

Beverage Break

12:30–1:30 pm NETWORKING

Lunch

3:00–3:30 pm NETWORKING

Beverage Break

SUNDAY SUNDAY, 10 SEPTEMBER 7:00–8:00 am Workshop Registration

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7:00–8:00 am NETWORKING

Workshop Continental Breakfast

8:00 am–4:00 pm WORKSHOP

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

WORKSHOP

Regulatory Strategy Forum for Biologics (Two-Day Workshop)

WORKSHOP

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

WORKSHOP

Regulatory Leadership Institute (Two-Day Workshop)

WORKSHOP

US Regulatory Essentials, Pharmaceuticals and Biologics

WORKSHOP

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

WORKSHOP

Regulatory Managers Bootcamp

WORKSHOP

Regulatory Intelligence Master Class

10:00–10:30 am NETWORKING

Beverage Break

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12:00–1:00 pm NETWORKING

Lunch

2:30–3:00 pm NETWORKING

Beverage Break

CONFERENCE SCHEDULE AT A GLANCE SUNDAY, 10 SEPTEMBER 7:30 am–6:00 pm Registration Open 4:30–6:00 pm PLENARY

Opening Plenary, Awards and Recognition

6:00–7:30 pm NETWORKING

Grand Opening of Exhibit Hall and Taste of National Harbor Reception

6:00–7:30 pm

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NETWORKING

RAPS Central Open

MONDAY MONDAY, 11 SEPTEMBER 7:00 am–6:00 pm Registration Open 7:00–8:30 am NETWORKING

Continental Breakfast

7:30–8:15 am CONVERSATIONS

Conversations That Matter 1: Interactions With Health Authorities (Hosted by RAPS Fellows)

CONVERSATIONS

Conversations That Matter 2: TransCelebrate Biopharma Inc.—How 18 Companies are Collaborating on Global Regulatory Engagement With an Aim to Improve Clinical Research (Hosted by RAPS Fellows)

8:30–10:00 am BIOPHARMA

Roundtable: What’s New in Europe

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BIOPHARMA

Global Development Biosimilars

FOOD

Functional Foods and Dietary Supplements: Manufacturing, Claims and Marketing

MEDICAL

Medical Device Single Audit Program (MDSAP)

MEDICAL

US FDA Regulation Changes: Clinical Evaluation: Obtaining Full FDA Approval of an IDE

MEDICAL

Reprocessing of Medical Devices in the Light of EU MDR

10:00 am–4:00 pm NETWORKING

RAPS Central Open

10:00 am–4:00 pm NETWORKING

Exhibit Hall Open

10:00–10:30 am NETWORKING

Beverage Break

10:30 am–12:00 pm BIOPHARMA

Regional Regulatory Update: Canada

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BIOPHARMA

Impact of PDUFA VI and 21st Century Cures on Regulatory Strategy

BUSINESS

Regulatory Obligations and How to Deal With Unethical Requests

FOOD

Exporting Food Safety to the Global Supply Chain

MEDICAL

ISO 13485:2016

MEDICAL

Recalls/Corrections/Removals

MEDICAL

Human Factors Studies/Usability Engineering

12:00–1:15 pm NETWORKING

Grab and Go Lunch and Open Exhibit Time

12:15–1:00 pm SPONSORED

Sponsored Education Session by Veeva | Unified Food-Grade Specifications: End-To-End Submissions Development—From Planning Through Archival

1:15–2:45 pm BIOPHARMA

Latin America Regulatory Convergence—Challenges Faced in the Regulations of Bio-therapeutic Products

BIOPHARMA

Regulatory Considerations in Clinical Study Design

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BUSINESS

Mergers and Acquisitions

FOOD

Introductions of Supply Chain Complexity by Multiple Food-Grade Specifications: Is There a Path Forward?

MEDICAL

EU MDR and IVDR: Overview

MEDICAL

Global Regulation Changes: India

2:45–3:45 pm NETWORKING

Beverage Break in the Exhibit Hall

3:00–3:45 pm SPONSORED

Sponsored Education Session by Maetrics | The New Medical Device Regulation in Europe

MINI

RAC Mini Session

CONVERSATIONS

Conversations That Matter 3: FDA's Newly Launched Oncology Center of Excellence (Hosted by RAPS Fellows)

4:00–5:30 pm BIOPHARMA

Labeling as a Driver of Regulatory and Commercial Strategy

BIOPHARMA

Effective Orphan Drug Development in a Challenging Regulatory Environment

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BUSINESS

The Secrets of Successful Meetings With Authorities—What You Don't Know May Hurt You

FOOD

Medical Foods/FSMPs—Access and Convenience Matters

MEDICAL

EU MDR: Clinical Evaluation/Classification

MEDICAL

Medical Device Innovation Consortium (MDIC) Including the National Evaluation System for Health Technology (NEST)

MEDICAL

Global Regulation Changes: Latin America

MEDICAL

Regulatory Strategy and Rapid Technology Innovation: From Additive to Algorithm

6:00–7:30 pm NETWORKING

Dine-Arounds

TUESDAY TUESDAY, 12 SEPTEMBER 7:00 am–5:30 pm Registration Open

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7:00–8:30 am NETWORKING

Continental Breakfast

7:30–8:15 am SPONSORED

Sponsored Education Sessions

NETWORKING

Networking Events

PLENARY

Plenary Events

PRECONFERENCE WORKSHOPS

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Join 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 amâ&#x20AC;&#x201C;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.

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 Trends (TwoDay 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 PDFmyURL - online url to pdf conversion

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 amâ&#x20AC;&#x201C;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.

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.

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. PDFmyURL - online url to pdf conversion

Regulatory Managers Bootcamp First impressions are everything. Do you know what image you are projecting when talking to your manager or another decision maker? During this high-energy, interactive workshop, you will receive feedback about how others perceive you. This awareness will help you, as you can influence your image. You will also learn techniques that will enable you to write documents that are clear and concise, even when you are under pressure. Finally, industry leaders will share their experiences and provide the dos and donâ&#x20AC;&#x2122;ts for managing challenging situations in the workplace.

Master Class in Regulatory Intelligence This interactive workshop will examine the fundamentals of global regulatory intelligence (RI), including what it is and isnâ&#x20AC;&#x2122;t, how it is conducted, the strategic value it brings to key partners and how it is imperative to regulatory decision making throughout a development program and lifecycle management of a therapeutic product. Discussion and hands-on exercises will provide insights on the collection, analysis, communication, and management of regulatory intelligence, with an emphasis on translating RI into a competitive advantage. The workshop will cover prescription drugs, biologics and medical devices with a focus on the US, EU and Canada.

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

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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 Wheelâ&#x20AC;&#x201D;a 180-foot observation wheel with panoramic views of Washington, DC.

Hotel Information PDFmyURL - online url to pdf conversion

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 AquafinaÂŽ 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.

R E S E R V E Y O U R H O TE L TO D AY

Phone: +1 877 491 0468 PDFmyURL - online url to pdf conversion

Please reference the RAPS Convergence for the discounted rate. Deadline date for discount: 19 August 2017

Travel Alert

We learned recently that an unnamed organization may have reached out to Convergence registrants and offered discount hotel rooms. Be aware that this is a scam. Any such group is not affiliated with RAPS in any way, and you should not provide any credit card or personal information to them. Instead, book your room directly with the hotel. (If you are staying at the Gaylord, book online.) If you have questions or need assistance, please contact marie.fredlake@conferencedirect.com.

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

Baltimoreâ&#x20AC;&#x201C;Washington International Airport (BWI) Taxi: $80 PDFmyURL - online url to pdf conversion

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)

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PRESENTER RESOURCES Step 1: Review presenter requirements and benefits (PDF)

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 PDFmyURL - online url to pdf conversion

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 (.pptx) (strongly encouraged but not required) and refer to the AV Specifications for Presentations and Equipment (PDF) document. Please refrain from biased and commercial references to individual companies, organizations or products. 28 July Presenters will receive a separate notification from RAPS with the presentation submission link and a personalized login. 28 Julyâ&#x20AC;&#x201C;11 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 Augustâ&#x20AC;&#x201C;6 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.

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 PDFmyURL - online url to pdf conversion

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 [.pdf]).

EXHIBITORS & 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 yearâ&#x20AC;&#x2122;s exhibitors who, in addition to working in PDFmyURL - online url to pdf conversion

submission and compliance, play integral roles in every stage of the healthcare product lifecycle including development, distribution, marketing and postmarket surveillance.

E X H I B I TO R F L O O R P L A N

D O W N L O A D P R O S P E C TU S

S P O N S O R S H I P O P P O R TU N I TI E S

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.

Demographics Attendee by Product Involvement

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Types of Products/Services Critical to Regulatory Professionals

Consultants

Regulatory Intelligence

CROs

Compliance/Regulatory

Notified Bodies

Software

Translations Services

Talent Acquisition Training

Complete form below for more information about exhibiting at 2017 RAPS Convergence in National Harbor, MD.

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Contact Information First Name Last Name Title Email Company Industry

--None--

Submit

Contacts Exhibits Email: exhibits@raps.org

SPONSORSHIP Leslie LeGrande Sales Executive, Exhibits & Sponsorship +1 301 770 2920, ext. 221 llegrande@raps.org

PROGRAM ADVERTISING Alyssa Hammond Account Manager, Network Media Partners PDFmyURL - online url to pdf conversion

+1 410 584 1989 ahammond@networkmediapartners.com

Thank You To Our Sponsors

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Regulatory Affairs Professionals Society