Starting Clinical Trials: You've Developed Your Product and Protected Your IP, What's Next?

Event Details

Schedule

August 24, 2011

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Location

Internet

AGG’s Food and Drug Team and Corporate Practice Group invites you to participate in the following complimentary webinar:

“Starting Clinical Trials: You’ve Developed Your Product and Protected Your IP, What’s Next?” being held Wednesday, August 24, 2011 11:30 am – 1:00 pm EDT. In this 90-minute webinar Terrence Gaffney, Partner in the Food and Drug Practice Team will address such issues as:

  • Dealing with the Food and Drug Administration (FDA) in a Pre-Investigational New Drug or Pre-Investigational Device Exemption Meetings
  • Dealing with the Institutional Review Board
  • Preparing for Phase I, II and III trials
  • Working with a Biostatistician
  • Working with the FDA and Clinical Research Organizations (CROs)
  • Entering into agreements with sites, principal investigators, CROs and suppliers
  • Negotiating significant terms of agreements, including obligations and governance, confidentiality and use, record keeping and access, liability and indemnification, ownership of intellectual property and publication rights

Registration 

  • If you have any questions please contact Tracey Chapman, Event Coordinator at tracey.chapman@agg.com.  
  • State Bar of Georiga CLE has been approved for 1.5 hours.