Pellizzari Consulting
GmbH

Dr. Josef Pellizzari, Managing Director and Principal Consultant

I have 20 years of experience working for Global Regulatory in large pharmaceutical companies, with a focus on data maintenance in Regulatory, the data flow towards Regulatory and the RIM systems used to manage the data.

Over time I worked in leading positions from PIM to XEVMPD, then SPL and IDMP, adapting the RIM systems to be the central data store. This rich experience has given me a wide overview how data flow within pharmaceutical companies, and a lot of detail experience how to ensure a smooth submission of data to regulators.

In addition to the extensive Regulatory experience I hold a master degree in computer science. From this unique vantage point I can process, transform and analyze your data, all the while understanding their business meaning. This approach has proven much more powerful than manual data inspections.

Leveraging this unusual skill combination I support companies in locating the IDMP data, analyze the suitability and correctness of the data, and advice how to set up processes and tools to master the data challenges.

I actively participate in the IDMP standards setting in ISO TC215 WG6, and have been a member of the EMA Focus groups on Data and Processes.

Since 2021 I work as an independent consultant located in Basel, Switzerland.

Expert consulting on IDMP requirements and implementation

• What is IDMP and what are the current and upcoming regulatory requirements?
• How does IDMP impact you? How do you get ready for upcoming regulatory requirements?
• Impact of IDMP on your RIM system and upstream systems.
• Use of IDMP data at regulators, including changed requirements for XEVMPD, submissions using the eAF web portal.

Support your IDMP data collection

• Where in the company can you find the IDMP data?
• Help with any manual data collection with prepared Excel sheets and data verification.

Data analysis across IDMP/XEVMPD/PMS and your RIM system

• Check your data for correctness and completeness.
• Verify your XEVMPD data for consistency and alignment to your RIM system (for manual processes).
• Verify the PMS data against your RIM system.

IDMP training

• Get an overview over ISO IDMP, and the background what IDMP is all about.
• Take a deep dive into the details of each IDMP attribute.

Get in touch!

Call +41 79 833 9906 (Central European Time Zone) during office hours,
or email at office@pellizzari.ch,
or pass by at the office location at Blauenstrasse 21, 2nd floor, in Basel.