| Starts: | Monday May 03, 2010 at 8:00am |
|---|---|
| Ends: | Wednesday May 05, 2010 at 3:30pm |
| Event Type: | Training/Seminar |
| Region: | Washington D.C. Metro Area |
| Location: |
Hyatt Arlington Hotel Arlington, VA US |
| Price: | $1,695.00 Register by 03/20/10 |
| Website: | http://www.peri.org/course_details.cfm?course=1979 |
| Industry: | pharmaceuticals |
| Keywords: | Ich, Cioms, Adverse Event, Periodic Reporting, E2 B, Safety Data, Psu Rs, Pharmacovigilance, Fda, Risk Management, Crisis Management |
| Intended For: | This course is intended for individuals working in safety surveillance, regulatory affairs, product development, data management, and computer systems who will benefit from knowledge of current regulatory developments in drug safety requirements, as well |
| Organization: | PERI |
This course focuses on regulatory requirements that impact the management and handling of drug safety data and adverse event reporting. Significant regulatory changes from the sponsor's and FDA's view will be reviewed, including current FDA regulations and Guidances and how they will be implemented. This course will also provide an opportunity for those working in safety surveillance to gain an in-depth understanding how these regulations relate to international activities in CIOMS and ICH. This course will be highly interactive, with participants partaking in small group discussions and case studies emphasizing expedited and periodic reporting, decision-making and crisis management.
Key Topics: - ICH and CIOMS Initiatives - FDA’s Office of Drug Safety - New Pharmacovigilance Initiatives - Electronic Submissions and E2B - Risk Management - MedDRA and SMQs - Expedited and Periodic Reporting - Product Liability Implications - Capturing and Exchanging Safety Data - Case Evaluation and PSURs - Crisis Management - FDA Perspective on Inspecting Safety Departments