An Automated Approach to Global Adverse Event Reporting in Pharmacovigilance

Clinical Trials, Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Friday, May 18, 2018

This webinar will discuss how you can automate complex document distributions to keep all involved parties – including health authorities, central and local ethics committees, investigative sites and the study team – informed about ongoing safety issues of an investigational medicinal product (IMP). It is a central obligation for the sponsor of a clinical trial to meet national regulations that must be followed when conducting regional and global clinical trials, which differ from region to region and country to country. By joining this webinar, you will learn how to handle these different requirements by using psiXchange in an elegant and timesaving way in the field of pharmacovigilance.

Featured speakers will provide insights into how:

  • Companies automate the distribution and dispatch of suspected unexpected serious adverse reactions (SUSARs) and other safety documents such as development safety update reports (DSURs) and expedited single and periodic safety documents, according to company-specific processes
  • Depending on system configuration, submission and oversight can be managed on a product basis and not only on a clinical trial basis, therefore removing the burden to coordinate different teams working on different clinical trials and allows for staff to focus on other more valuable activities
  • The tool interfaces with any safety database, accepts documents sent in from any external system or manual upload in any format (e.g. XML, PDF, XLS) and automatically handles specific distribution methods, such as fax, email, courier and E2B
  • You can overcome many traditional manual obstacles and track progress in real time with a full tracking and audit trail

At the end of this webinar, you will understand the benefits of using the tool and how your organization can proactively manage receipt acknowledgements, oversee distribution from a user-friendly dashboard and increase your overall compliance in a cost-effective way through automation.

Speakers

Tim Billington, Chief Sales Officer, pharmasol

Tim Billington, Chief Sales Officer, has been working in the pharmaceutical industry for more than 20 years. Starting his career at a CRO within data management and project management using various software applications, he then moved to Oracle where he led a number of global implementation projects for Oracle Clinical and Oracle RDC. In 2001, he moved to pharmasol, where he co-developed the rapidLIVE implementation approach for accelerated application deployment. He now leads the sales team at pharmasol across all areas of the business.

Message Presenter

Dr. Christian Wufka, Director Product Strategy, pharmasol

Dr. Christian Wufka joined pharmasol in 2017 after working 10 years in the pharmaceutical industry in pharmacovigilance in both pharma and a global top 3 CRO company. He is responsible for strategy and product vision within pharmasol and works closely with customers, software development and business development.

While working in the field of pharmacovigilance, he was responsible for regional clinical trial safety oversight and global implementation of new, innovative technologies related to safety and pharmacovigilance. Prior to his work in the pharmaceutical industry, Dr. Wufka graduated in life sciences and worked on his PhD thesis at the Technical University Munich.

Message Presenter

Who Should Attend?

Senior professionals from pharmaceutical and biotechnology companies working within:

  • Clinical Operations
  • Drug Safety and Risk Management
  • Medical Scientific Liaison
  • Medical Writing
  • Pharmacovigilance / Aggregate Reporting
  • Product Safety
  • Patient Safety
  • QPPV (Qualified Person for Pharmacovigilance)
  • Regulatory Affairs
  • Site Management / Site Contracts
  • Strategic Planning

What You Will Learn

  • Automating the distribution and dispatch of suspected unexpected serious adverse reactions (SUSARs) and other safety documents according to company-specific processes
  • How to keep all involved parties informed about ongoing safety issues of an IMP to meet national regulations through automation of complex document distributions
  • Removing the burden to coordinate different teams working on different clinical trials on a product and clinical trial basis to manage submission and oversight

Xtalks Partner

pharmasol

pharmasol is a leading provider of innovative technology solutions, GxP compliant hosting and implementation services for the life sciences industry.

With headquarters in Germany and offices in the UK and the US, pharmasol has proven experience in delivering successful global projects across companies of all sizes.

With over 15 years’ experience in Data Management, Trial Operations and Pharmacovigilance, pharmasol staff are recognized as experts in developing software and providing support for industry leading applications.

pharmasol’s business and technical consultants have rich industry experience and are committed to providing efficient and innovative solutions and services.

For more information visit www.psixchange.com and www.pharmasol.de.

Related Webinars

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account