Good Clinical Practice (GCP) Conference

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Wednesday, April 13, 2016
8:00 am – 5:00 pm

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

This one day seminar will provide an in-depth review of some of the latest FDA guidances and provide practical tips to assist participants in understanding, applying and successfully complying with GCP guidelines.

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

  • Risk Management 
  • Audit & Inspection Readiness
  • Developing Protocols 
  • IRB Applications
  • FDA 21 CFR and Guidance Documents 

The event will also include a panel of industry leaders sharing the most recent FDA updates and real-world strategies for overcoming associated challenges. 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.

 

Agenda 

  • 8:00-8:30 - Registration 
  • 8:30-9:00 - Introduction 
  • 9:00-10:00 - Risk Management Overview 
    • Presented by Lee Truax-Bellows, President and CEO, Norwich Clinical Research Associates
  • 10:00-10:15 - Morning Break 
  • 10:15-11:15 - Audit / Inspection Readiness 
  • 11:15-12:15 - Developing Protocols 
    • Presented by Kathi Durdon, Director of Operations, CNY Biotech Accelerator, Upstate Medical 
  • 12:15-1:15 - Lunch
  • 1:15-2:15 - IRB Applications
    • Presented by Glenda Guest, Vice President, Norwich Clinical Research Associates
  • 2:15-2:30 Afternoon Break
  • 2:30-3:30 - FDA 21 CFR Part 11 (Electronic Records) and Guidance Documents
  • 3:30-4:30 - Regulatory Update and Panel Discussion 
    • Moderator: Glenda Guest
    • Panelists: Lee Truax-Bellows, Kathi Durdon, Roxanne Tavakkol, Brian Toglia
    • Regulatory update provided by Loeb & Loeb 
  • 4:30-5:00 - Networking

Registration

Online registration is required for attending the event.

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

CEU credits are available through ACRP for an additional cost, more information to come. SoCRA members can receive seven credits for attending this program. 

 

Thank you to our sponsor!

Tanner Ibbotson

The professionals of Tanner-Ibbotson, Inc. understand that life science organizations must invest limited resources and time into the science and talent necessary to bring to fruition new life saving or life changing products and technology. Tanner-Ibbotson professionals serve life science companies in all stages from research & development to clinical trials to commercialization. They also understand that these same transformational organizations face countless financial, operational, regulatory and legal challenges. Each issue is laden with risk, yet few life science companies have time, expertise or resources to focus on corporate risk management and insurance, while at the same time innovating to save and change lives. They believe that this dynamic and revolutionary industry is remarkably underserved by the insurance brokerage industry. At Tanner-Ibbotson, Inc., the Life Science Practice is committed to serving this industry. It would be the company's privilege to serve you, as you pursue your core mission - to improve the quality of life for this generation and generations to come.

Please follow the link to Tanner-Ibbotson's webpage to see the coverage offering and appetite list - www.tanneribbotson.com/LifeScience.aspx

 

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