Good Clinical Practices (GCP) Conference 2017: Regulatory Issues in Clinical Research

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Wednesday, April 5, 2017
8:00 am – 5:00 pm

Location: Harris Beach PLLC, 99 Garnsey Rd, Pittsford, NY 14534

This one day seminar will provide an in-depth review of new applications and regulatory topics in clinical research , as well as provide practical tips to assist participants in understanding, applying and successfully complying with GCP guidelines. Tailored for clinical research and regulatory professionals in drug and device companies, hospitals and research organizations and for students from research institutions who are conducting clinical trials or seeking IRB approval, this program full of valuable information and is a great value.

Experts from the Bio/Med industry will share their knowledge and experience on a wide spectrum of topics such as:

  • Clinical monitor success and Good Documentation Practice
  • FDA warning letters and Form 483
  • New approaches in clinical science for developing evidence
  • Quality systems in clinical trials
  • Clinical evaluation assistance in purchasing decisions, safety and effectiveness and validation of medical devices and software 
  • 21 CFR 11 and E-consent 

Agenda

  • 8:00-8:30 - Registration 
  • 8:30-9:00 - Introduction 
  • 9:00-10:00 - How Clinical Trials Can Assist Stakeholder Decisions
    • Presented by Marilyn Waxberg, Senior Principal Advisor, Regulatory and Quality Solutions (R&Q)
  • 10:00-10:15 - Morning Break 
  • 10:15-11:15 - Quality is No Accident: The Quality Systems Approach
    • Presented by Dr. Dorcie Jasperse, Executive Director, Clinical Compliance, Raland Compliance Partners 
  • 11:15-12:15 - New Approaches in Clinical Science for Developing Evidence
    • Presented by Marilyn Waxberg, Senior Principal Advisor, Regulatory and Quality Solutions (R&Q)
  • 12:15-1:15 - Lunch
  • 1:15-2:15 - Striving for Sustainability - Quality System Improvements Post 483 / WL Situations
    • Presented by Joel Dziengielewski, Director - Healthcare and Life Sciences Disputes, Regulatory, Compliance & Investigations, Navigant
  • 2:15-2:30 Afternoon Break
  • 2:30-3:00 - Monitoring Best Practices
    • Presented by Lorraine D. Ellis, President/CEO, Research Dynamics 
  • 3:00-3:30 - The Importance of Good Documentation Practices
    • Presented by Linda Kniebel MS HS, Director of Business Development, Novatek Communications, Inc.
  • 3:30-4:30 - eConsent: Deployment Considerations
    • Presented by Dr. Irfan Khan, Founder and Chief Medical Officer, Circuit Clinical
  • 4:30 Networking

Registration

Online registration is required for attending the event. Please note that registration closes on March 29. 

The cost is $175 for MedTech members and $210 for non-members.

Attendance at this event has been pre‐approved for 6 contact hours of research-related education on applications for Maintenance of ACRP’s CCRC®, CCRA®, or CPI® certification designations.

Who Should Attend 

  • Clinical Quality Assurance (CQA)
  • Clinical Quality Control (CQC)
  • Clinical Trial Operations/Management
  • Clinical Research 
  • Quality Management/Global Quality Management
  • Clinical Monitoring
  • Regulatory Affairs
  • Safety and Risk Management/Operations

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