Program Title: FDA-CDER: Three Topics from 2015 Conference Attendees
Location: Children’ Hospital Colorado 13123 E. 16th Avenue, Aurora, CO 80045
Speaker: David Burrow, PharmD, JD
- Chapter Member - $0
- ACRP Member - $25
- Non-Member - $25
Program Description: In this session, FDA personnel from the Center for Drug Evaluation and Research will discuss three topics which were identified by attendees of the 2015 ACRP Global Conference as subjects which they would most like to hear FDA discuss. Topics will include: (1) an update on FDA's experience with Risk Based Monitoring; (2) a description of FDA's experiences when an inspection goes bad (and what to do about it); and (3) a description of strategies to ensure "sufficient" clinical investigator oversight. Lastly - in this session, attendees will have the opportunity to suggest potential topics for FDA to include in a similar presentation next year.
- Explain FDA's experience with Risk Based Monitoring
- Describe FDA's experiences when an inspection goes bad.
- Describe key strategies for sufficient clinical investigator oversight.
- 5:15 – 5:30 pm – Registration
- 5:30 – 6:30 pm – Presentations and Q&A
- 6:30 – 7:00 pm – Refreshments and Networking
Target Audience: All clinical research professionals.
1 contact hour has been approved for through ACRP. Membership is not required for online registration/application of contact hours.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
To receive contact hours: Purchase the contact hours, sign in at the registration desk and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate. After 30 days, contact hours are no longer available.
Refund Policy: No refunds will be provided unless the chapter cancels program.
Questions? Contact Theresa Wilson at Theresa.firstname.lastname@example.org.