Training

Pharmacovigilance Training Courses

 

HighPoint’s Pharmacovigilance Practice provides a wide range of training courses to support your operations and systems.

 

System Training

The following Pharmacovigilance training courses can be delivered at your site or over a web conference. The cost of the course is based on standard HighPoint time and materials rates rather than on a per-person basis, providing significant cost savings to a classroom-based training model.

End-User Training • A three to five day course taught on your site on the basics of using your safety system for managing and reporting your adverse event, product complaint, medical error, and pregnancy/lactation exposure cases. The course includes modules on Case Management, Case Data Query, Reporting, and Data Consistency Checking.

Administrator Training • A two-day course taught on your site covering the fundamental aspects of administering Oracle AERS or Argus. The course includes modules on technical Infrastructure, User Administration, Product Repository Maintenance, Basics of Workflow Configuration.

Advanced Configuration and Management • A two- to five-day course taught on your site exploring the configuration and management in exhaustive detail. The course can be tailored to your specific needs, and can include modules on Developing Custom Edit Checks, Adding Custom Fields, Data Model Review for ad hoc access, Managing Synonym Lists with Oracle TMS or dsNavigator, Establishing Clinical Data Reconciliation, and other topics.

PSUR/Aggregate Reporting Workshop • A two- to five-day interactive workshop held on your site focusing on the design, configuration, and production of the PSUR and other aggregate reports. During the course of the workshop the key data elements and processes required for producing the PSUR are reviewed, the various configuration options are analyzed, and the specific configuration options for your company are documented and deployed.

Overview of Pharmacovigilance • A two-hour overview of the history and current practices. This course is suitable for an orientation for new hires in the drug safety or pharmacovigilance offices.

Pharmacovigilance Best Practices • A two-hour overview of best industry practices. The course is delivered for small, medium, and large companies.

Pharmacovigilance Technology Review • A two-hour review of the major commercial systems available for pharmacovigilance and safety reporting.

Selecting a Pharmacovigilance System • A two-hour overview of the process of evaluating the commercial systems for pharmacovigilance. The course provides a high-level methodology to manage the entire process of developing requirements, evaluating the software and the vendors, making the selection, then initiating the implementation.

 

Oracle AERS and Oracle Argus Computer-based Training Modules

The Pharmacovigilance Practice offers a suite of computer-based training modules that can be taken on-demand or deployed within your internal training environment.

Booking Cases • A one-hour review of the process of creating new cases, including a review of the Case ID Generation and Duplicate Check functions.

Managing Cases • A two-hour review of case management features, including case workflow basics. 

Discrepancy Management • A two-hour review of data consistency checking and discrepancy management.

Basic Case Query • A one-hour review of the basics of using the Query Module to identify cases of interest.

Advanced Query Techniques • A two-hour review of advanced query techniques in Oracle AERS and Advanced conditions in Oracle Argus.

Running Reports • A one-hour overview of the basics of running reports.

Submission Management • A one-hour review of the submission management process, including running draft versus submission reports, and tracking initial and follow-up reports.

User Administration • A two-hour review of the features of user administration, including a review of the security model and the process for creating and managing users.

 

Customized Pharmacovigilance Training

Any and all of the training materials and courses above can be combined into a full training curriculum for your department’s needs. The Pharmacovigilance Practice can develop train-the-trainer materials, computer-based training materials or focused training courses tailored for your specific needs.

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