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:

Speakers

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.

Message Presenter

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.

Message Presenter

Who Should Attend?

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

Xtalks Partner

Intralinks

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.