FDA/SCT Benefit-Risk Workshop:
Bridging Qualitative and Quantitative Assessments
December 5-6, 2013
The Universities at Shady Grove Conference Center, Rockville, Maryland
Due to the US Federal Government shutdown the workshop has been moved to December 5-6, 2013
Benefit-risk evaluation is essential in drug development and regulatory approval. In recent years, regulatory agencies in the US and abroad have been developing systematic guidelines and methods for making decisions, especially in cases when it is unclear whether the benefits of a drug outweigh the risks. This workshop will bring regulatory, academic, and industry representatives together with the aims of:
- Gaining a clear understanding of the current regulatory environment for B-R, including changes under PDUFA V
- Developing a common understanding of the key B-R methods, including both quantitative and qualitative methods
- Examining the relative strengths and weaknesses of qualitative and quantitative methods through a series of case studies
- Identifying best practices for and challenges in implementing formal B-R methods.
- Engaging in dialogue and advocacy efforts with industry leaders, the scientific community and regulators to develop a consensus understanding of the use of benefit-risk approaches.
The target audience for this program includes statisticians, clinicians, epidemiologists, drug safety professionals, and medical scientists who are involved in the benefit-risk assessment of drug products or are interested in recent developments in benefit-risk assessment; regulators who face complex benefit-risk decisions; and regulatory and drug development policymakers.The workshop is organized by FDA and QSPI, a committee of the SCT. The program co-chairs are Qi Jiang, PhD (Executive Director, Global Biostatistical Science, Amgen) and Jonathan Norton, PhD, (Mathematical Statistician, Office of Biostatistics, CDER, FDA).
|Nonprofit/Academia (full time)
In order to register you will have to create an account. If you are an SCT Member this account is separate from your SCT Member account and you will need to create a new username and password that you will use for this meeting only.
For registration information, please email QSPIMeeting@fernley.com
TRAVEL & HOTEL
The Hotel and Conference Center are easily accessible from either Ronald Regan Washington National Airport (approximately 25 miles) or Dulles International Airport (approximately 29 miles). Attendees should make airline reservations as early as possible.
A block of rooms is being held at a reduced rate of $125.00 at the Crowne Plaza Washington, D.C. -Rockville Hotel. Please click here to reserve a room online
or contact the Crowne Plaza Hotel at 301-840-0200 and ask for the SCT rate. Rooms are available until Friday, September 21, 2013 or when the block is full. The Crowne Plaza Washington, D.C. - Rockville Hotel is located 1.2 miles from the Conference & Events Center. The Hotel address is 3 Research Court, Rockville, MD 20850.
The Crowne Plaza Washington D.C.-Rockville Hotel offers a Complimentary Daily Shuttle for hotel guests to; Shady Grove Metro, Falls Grove Shopping Center, Washingtonian Center and places of business within a 3 mile radius of the hotel. This 9 person shuttle is on a first-come, first-served basis, but arrangements can be made in advance with the hotel to travel to and from the Universities at Shady Grove Conference Center.