Pharmacovigilance Oversight – Best Practices for Safety IT
Date: June 14, 2017 (60 minutes)
Find out how the use of information technology for drug safety has evolved over the last decade in line with changing demands from the business. Hear about current best practice, common mistakes and expectations for the future.
Topics covered will include:
- Electronic Data Transfer
- Investigator/ERB portal reporting
- Upcoming regulation adherence
- Safety application upgrades due to end of life
- Integrations with other clinical and safety applications (EDC, etc)
- Safety monitoring: Up-to-date information on safety data (real time vs. ETL transferred / lagged data)
- Cost of getting BI applications (software + FTE) vs. built in solutions within safety apps
- Global reporting (APAC vs. ROW)
Keywords: Drug Safety, Pharmacovigilance, Clinical Data
Andrew Mitchell, Director of Life Sciences, Synchronoss
Andrew Mitchell has almost 20 years of experience delivering software to the pharmaceutical industry and has been on the forefront of driving key innovation such as the adoption of EDC and Electronic Safety Reporting (E2B). His career includes positions at Covance, Relsys, Medidata, and he led the EU Drug Safety Practice at BioPharm prior to joining Intralinks where he’s responsible for the Life Sciences vertical, regularly speaking and writing on topics related to biopharma deal making, clinical collaboration and drug safety.
Kapil Kedia, Founder & CEO, SyNRG Solutions
Kapil Kedia runs SyNRG Solutions, a drug safety software provider and consultancy.
For almost 2 decades Kapil has been on the forefront of driving the industry’s innovation - including as the principle product manager of Argus Safety at Relsys and Oracle Health Sciences (after their acquisition).
SyNRG offer pharmacovigilance system hosting, setup, migration, integration and implementation expertise along with proprietary tools to assist with:
- Safety data exporting, analytics, visualization and metrics
- Custom reporting
- Medical and drug dictionary up versioning and centralized coding
- Electronic submissions including automated E2B(R2) to R3 conversion
Clients range from small biotech’s to the world’s largest pharmaceutical organizations.
|THIS PROGRAM IS INTENDED FOR|
- Clinical Trials Executives
- Drug Safety Leaders
- Pharmacovigilance Auditors
- Business Development Leaders
- Chief Medical Officers
- Chief Executive Officers
This webinar will additionally benefit biotech start-ups thinking about safety.
|OUR XTALKS PARTNER FOR THIS EVENT|
Synchronoss is transforming collaboration and mobility across business boundaries, enabling users to work anytime, anywhere, on any device improving workflow and productivity. We are leading the digital transformation of global business with a secure, full-featured content collaboration and mobility platform that scales and configures to every type of company in all major industries worldwide.