| |
|
|
|
GlobalCompliancePanel, Online Training Webinar
2010-10-05
Why should you attend:
Cost Issues: - Blockbuster drugs coming to end of patent life
- Keeping products on the market without interruption becomes more essential with reduced pipeline
- Current economic environment drives cost saving efforts
- Peaks and valleys in case processing workload emphasize the need to optimize expensive resources
Regulatory Issues: - Increased safety regulations by global government agencies
- Requirement for added safety data slows down the product approval process
- FDAAA enforces more stringent requirements for monitoring post-marketing safety
Public confidence issues: - Heightened public awareness of product safety
- Product safety reflects company image and consumer confidence
Areas Covered in the Session: The following aspects will be examined: - Identify areas that require attention - strategy, planning, execution and control of case processing and signaling
- Reference processes for case processing and signaling
- Identify non-value added activities, redundancies, parallel and serial operations, cost-benefit of technology
- Align strategy, business process, metrics and SOPs
- Outsource/offshore strategy
- Identify compliance risks and inefficiencies in case intake, data entry, coding and evaluation, submissions.
- Signal assessment such as analysis of company data, comparison to FDA and WHO databases, prioritizing signals, case series analysis, medical significance of confirmed signal, preparing signal assessment report, and recommendations for label update.
- Use of signal triage algorithms such as disproportional reporting, positive re-challenge, rapid reporting increase, new drugs, serious reactions, and reactions of special interest.
- Compliance with FDA guidance as specified in “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” March 2005.
- Timing and frequency of signal detection, triage, and data mining runs.
Who Will Benefit: - Clinical Safety/Pharmacovigilance
- Quality management
- Clinical research & development
|
|
|
|
|
|
|
|
Organized by:
|
|
GlobalCompliancePanel |
|
|
Invited Speakers:
|
|
Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA. He has 25 years’ experience in drug safety & pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide. DLB was acquired by eResearch Technologies in 1997; since then Steve has worked as an independent consultant.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
2010-10-04
|
|
|
|
|
|
|
|
Registration:
|
|
Live live online training only for one participant Price: $245.00 Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) Price: $995.00
|
|
|
E-mail:
|
|
webinars@GlobalCompliancePanel.com
|
|
|
|
|
|
|
|
|