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
- If you have any questions please contact Tracey Chapman, Event Coordinator at firstname.lastname@example.org.
- State Bar of Georiga CLE has been approved for 1.5 hours.