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Home  >  Conferences  >  12th Annual Device Research & Regulatory Conference
CME : 17.75
Conference Brochure

Conference Summary

12th Annual Device Research & Regulatory Conference is organized by Society of Clinical Research Associates, Inc. (SOCRA) and will be held during Apr 25 - 27, 2018 at Miami Beach Resort and Spa, Miami Beach, Florida, United States of America. This CME Conference has been approved for a maximum of 17.75 AMA PRA Category 1 Credits.

Preconference Workshop :
Device Basics Preconference Workshop April 25, 2018 (11:30 a.m. - 5:00 p.m.)

The Pre-Conference Half-day Workshop is designed to provide a comprehensive medical device regulatory overview and is a fundamental precursor to the main program and includes:

• Demystifying Medical Devices
• How Can Knowledge of Good Laboratory Practice (GLP) Regulations Make Your IRB Minimize Patient Risks?
• What is Q-sub and the FDA’s Pre-Submission Program

Main Program – Day 1:

• Introduction to the 510(k) Program and Case Study
• Introduction to the PMA Program
• A Key Resource for Industry – Working with the CDRH Office of the Ombudsman
• Navigating the FDA/CDRH Website
• US Clinical Trial Reimbursement
• Balancing the Clinical Trial Budget
• Panel Discussion

Main Program – Day 2:

• The Ten Best Innovation Practices Among Healthcare Innovation Centers
• Risk Management in Medical Device
• European Union Changes in Medical Device Regulations
• Medical Post Market Clinical Follow-up (PMCF): Adjusting to the ‘new normal’ in the MDR Era
• Managing Medical Device Product and Project Lifecycles in an Evolving Regulatory Landscape

Learning Objectives: Pre-Conference Workshop

The participant will be able to:
• Discuss FDA regulations including risk categorization and device classifications.
• Describe Good Laboratory Practice and how it can be used to assist IRB review.
• Discuss FDA CDRH Pre-Submission process.
• Discuss during Question & Answer with speakers to gain additional understanding of the FDA Regulatory Process and particular experiences.

Learning Objectives: Conference

The participant will be able to:
• Discuss 510(k) process relative to submission requirements.
• Describe the Premarket Approval Program assessing safety and effectiveness of Class III devices.
• Discuss value and process to utilize Ombudsman resources, particularly for dispute resolution.
• Describe resources available through the FDA CDRH website.
• Discuss US clinical trial reimbursement.
• Apply budget approaches to maximize reimbursement and expectations.
• Discuss a DUKE-led study regarding how healthcare innovation centers launched initiatives and how they compare to industry.
• Discuss risk management and the total product life cycle and human factors related process.
• Explain European Union Changes in Medical Device Regulations that will impact compliance.
• Comprehend Post Market Clinical Follow-Up
• Discuss tools and process to promote a partnered approach to protocol development.
• Actively discuss issues and topics germane to attendee roles and responsibilities.

Conference Details

Session Brochure : Download Session Brochure

Registration Desk

Contact No. (215) 822-8644,
(800) 762-7292
socramail@aol.com, office@socra.org

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Venue Address

Miami Beach Resort and Spa
4833 Collins Avenue
Miami Beach, Florida, United States Of America

Official Hotel

Miami Beach Resort and Spa,

4833 Collins Avenue,

Miami Beach, Florida, United States of America 33140,

+1 305-532-3600


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Hotels Near Venue

Grand Beach Hotel
0.04 miles from venue
Free Wifi
Onefinestay - Miami Beach Private Homes
0.25 miles from venue
Free Wifi

Session Details

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