$50 – $100

2018 Clinical Research Summit

Event Information

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Sheraton Puerto Rico Hotel & Casino

200 Convention Boulevard

San Juan, San Juan 00907

Puerto Rico

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Refund Policy

Refund Policy

No Refunds

Event description


Co-organized by: The US Food and Drug Administration (FDA), the Yale Center for Clinical Investigation (YCCI), Hispanics Increasing Diversity to Enhance Advocacy in Science (HIDEAS)-Puerto Rico, Universidad de Puerto Rico- Medical Sciences Campus, Universidad Central del Caribe, Ponce Health Sciences University, the Puerto Rico Science, Technology and Research Trust (PRST), and the Puerto Rico Consortium for Clinical Investigation (PRCCI).

  • The 2018 Clinical Research Summit is a one of a kind and exciting full day event that will bring together Puerto Rico leaders from all the groups involved in clinical research: patients, FDA, investigators, sponsors, clinical units/sites and Clinical Research Organizations. An opportunity to connect and network with all the key players and special guests.
  • Explore the new advances in clinical research locally and internationally, learn from opinion leaders about diversity in clinical trials, why it is important and how to achieve it, dive into emergency preparedness and response under the light of Hurricane Maria, and discuss best practices on quality and compliance with the FDA.
  • Visit the Exhibitors Hall to find out about sponsors, research sites, patient/community groups and others.

See our Preliminary Program for details.


7:00AM – 5:00PM

Registration Open & Exhibit Hours

7:00AM Registration Opens

9:00AM Welcome Remarks & Introduction

9:15AM Keynote Speakers

10:30-10:45AM Coffee Break /Exhibitors Hall

10:45AM Patient-centric Panel Discussion

12:00PM-1:00PM Lunch

1:00- 5:00PM Afternoon breakout sessions

3:00-3:15PM Coffee Break

Session 1 | Quality and Compliance

Session 2 | Diversity in clinical trials

Session 3 | Emergency preparedness/lessons learned from Maria

Confirmed Speakers include:


  • Annette Melendez, Consumer Safety Officer, US Food and Drug Administration, Puerto Rico Office: “Inspectional Process”
  • Dr. Cynthia Kleppinger – Medical Officer, Division of Clinical Compliance Evaluation, Center for Drug Evaluation and Research, US Food and Drug Administration: “Understanding Principal Investigator’s Responsibilities and Oversight of Clinical Investigations” and “Compliance in Clinical Research ‘Doing it Right the First Time”
  • Jovonni Spinner, MPH, CHES, Senior Public Health Advisor, US Food and Drug Administration, Office of Minority Health: “Recruitment Challenges – Precision, Personalized and Diverse: New Tools and Strategies”
  • Anne E. Johnson, District Director Philadelphia District Office and the Program Division Director of OBIMO Division 1 (East), US Food and Drug Administration: "Emerging Issues and Trends in Clinical Research"
  • Brenda Stodart, PharmD, BCGP, Captain, United States Public Health Service Director, CDER Small Business and Industry Assistance Program (CDER SBIA) Division of Drug Information, US Food and Drug Administration: "What Can SBIA Do for You"

Guest Speakers:

  • Lester Martínez López, M.D., M.P.H., F.A.A.F.P., Major General (Retired), U.S. Army, President & CEO, Martinez Medical Consulting
  • Dr. Gabriela Dávila Loaiza, Director of Clinical Site Management, North Cluster of LATAM, Global Product Development, Pfizer
  • Dr. Oscar Soto-Raíces, Medical Director Mindful Clinical Research, former President, Puerto Rico Rheumatology Association, founder and first President of Puerto Rico Foundation for Rheumatic Diseases - Fundación FER
  • Tesheia Johnson, MBA, MHS, Associate Director for Clinical Research Yale School of Medicine and Chief Operations Officer for Yale Center for Clinical Investigation
  • Amarilys Silva, PharmD, BSPharm, Medical Leader, Puerto Rico Medical Affairs Department, Eli Lilly and Company
  • Helen Kellar Wood, Ph.D, Lead, Diversity & Patient Engagement, Research and Development at Bristol-Myers Squibb
  • James A. Borowiec, Ph.D., Professor of Biochemistry and Molecular Pharmacology; Director, Research Emergency Management and Enterprise Resilience, Office of Science and Research, New York University School of Medicine
  • Stephanie Berger, Director of Quality and Training of Puerto Rico Consortium for Clinical Investigation (PRCCI)
  • Dr. Gregorio Cortes Maisonet, MD, CPI, President and Research Director, GCM Medical Group, PSC
  • Dr. Andrés Emanuelli Anzalotta, MD, ophthalmologist, President and Research Director, Emanuelli Research and Development Center, LLC
  • José F. Rodríguez Orengo,Ph.D., Professor and Associate Director of Biochemistry at University of Puerto Rico, School of Medicine; CEO & CSO at Fundación de Investigación- FDI Clinical Research
  • Dr. Barbara Segarra Vázquez, MT, DHSc, Dean of School of Health Professions, University of Puerto Rico, Medical Sciences Campus
  • Kenira Thompson, Ph.D., Dean of Research Ponce Health Sciences University
  • Dr. Francesca Carvajal, Regional Head of Clinical Operations for GCTO at Merck

*Full agenda/ program will be issued upon confirmation of all speakers



You can save up to $50 on the Registration! If registered in our early bird, before March 31st, 2018.


Summit’s Registration Fee Includes (For All Registered Attendees); Access to Program Conferences, Exhibitors, Coffee Breaks, Lunch, and Certified accreditation.


Recommended Registration is through Online Registration System, by credit card payment.

VISA, MasterCard, AMEX and Discover are accepted. Online registration will close on MAY 8, 2018 at midnight.


Email contact@303.digital for registration assistance (Office Hours: Monday to Friday from 8:30am to 5:00pm)

OR for more information send us an email | info@bigthinkgroup.com or call us at (787) 523-5870


Participants with special needs, particular allergies or who require a special diet, please contact us via email to info@bigthinkgroup.com; AFTER you have registered to coordinate special accommodations, alternative menu options, etc.


All completed transactions will be final. Registration Fees are NON-Transferable.

Refunds will be made ONLY with written notice of cancellation and must be received prior to April 20th, 2018. Request for Full Cancellation will be refunded less a $50 administrative fee. After April 21, 2018, NO REFUNDS WILL BE ISSUED. No-shows are not eligible for a refund. Approved refunds will be processed after completion of the event, paid for check and mailed to the postal address provided on the registration form.


Participant physicians, nurses and medical technologists are eligible and can take advantage of attending this event and will count for 6-7 contact hours accreditation (local and US). Please make sure to provide your email so we can send you the application form to be submitted prior to the event.

This educational activity has been submitted for accreditation to the pertinent Medical Boards and the University of Puerto Rico for Category 1 credits.


PRCCI and affiliate organizations of the 2018 PR Clinical Research Summit may take photographs and/or record audio and video at this event. By registering, you consent to the use of photographs and videos taken during the Event in its promotional form.


What are my transportation/parking options for getting to and from the event:
Car rentals from major companies are readily available at the Airport.

SJU Luis Muñoz Marín (SJU)

Travel Distance: Approximately 11.27 km/7.0 miles


  • Fee: $20 USD
  • Travel Time: 13 minutes

Isla Grande Airport (SIG)

Travel Distance: Approximately 1.61 km/1.0 miles


  • Fee: Taxi fares are $10 to $15.
  • About: Smaller airlines serving the Caribbean region often fly into Isla Grande Airport (SIG).

Sheraton Hotel Parking Flat Fee Rate is $12.00 plus tax per day, for participant Registered in our Summit.

Hotels | Lodging

The Sheraton Hotel & Casino has no occupancy available for the dates of the Event. However, here are some suitable hotel options you may consider when planning your trip:

Hyatt Place San Juan City Center (located in the Convention Center)

Telephone: 787-721-3000 | www.sanjuancitycenter.place.hyatt.com

Rate: $189 USD

Additional local taxes and resort fees may apply

The Condado Plaza (Hilton) 1.3 miles from Convention Center

Telephone: 787-372-2070 | www.condadoplaza.com

Rate: $195 USD

Additional local taxes and resort fees may apply

Hyatt House San Juan (located in the Convention Center)

Telephone: 787-977-5000 | www.sanjuan.house.hyatt.com

Rate: $239 USD

Additional local taxes and resort fees may apply

Please visit our website, www.prcci.org for updates on our events.

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Date and Time


Sheraton Puerto Rico Hotel & Casino

200 Convention Boulevard

San Juan, San Juan 00907

Puerto Rico

View Map

Refund Policy

No Refunds

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