Dr. Marc Zittartz
Head of Central Europe
Principal Consultant and Managing Director, Insife Germany since 2021. Marc Zittartz is an experienced leader and consultant in pharmacovigilance technology and processing. He is based out of Cologne, Germany.
Marc has been crossing the frontier between IT and R&D in the pharmaceutical industry in Europe and the USA for more than 15 years. He supports R&D divisions to improve their business processes through the optimized use of information technology.
Meet the Expert
Marc Zittartz, Principal Consultant and Managing Director, Insife Germany since 2021
Today Marc is Principal Consultant at Insife. His main fields of expertise are business processes and applications for pharmacovigilance, supported by proven knowledge in international team leadership, project management, computerized systems validation, and business intelligence.
Prior to his consulting career Marc headed the Drug Safety IT and Application Management groups at UCB and Grünenthal, respectively. In these roles he was the project leader for the implementation or upgrade of Pharmacovigilance IT systems. He has experience in designing and implementing signal detection and management systems. At Grünenthal Marc successfully conducted a business process improvement initiative for the Global Drug Safety department.
As an expat for Schwarz Biosciences Inc. (USA) for 3 years Marc Zittartz gained experience in a cross-cultural environment as well as in clinical development.
The cross-border insights into both clinical development and regulatory affairs gives Marc a unique perspective and enables him to advice clients in the process of choosing and implementing the right solutions to optimize their PV.
The Market Perspective
Working from the Insife office in Cologne, Germany, Marc benefits from a position right in the centre of Europe with natural strong ties to the surrounding European countries, the EMA and stakeholders representing some of the internationally market leading companies within life and health science.
According to Marc there has been some quite significant changes when it comes to the perception and practices involved in PV:
“During the massive rollout of the Covid19 vaccine programme we saw an unprecedented wish among the recipients to report side effects, which subsequently led to a general increase in the need for Pharmacovigilance. This is undeniably an extremely positive development. However, it has put a massive pressure on the companies within healthcare and life science. There remains a technical gap when it comes to PV. Companies simply don’t have the digital solutions implemented to handle the increase in PV activity and in large respects still relay on manual handling.”
According to Marc it is not all bad though:
“This will inevitably accelerate the digitization of PV. With the most likely consequence that the use of AI will be implemented on a broad scale.”
The Regulatory and Political Perspective
But one thing is a change in the public view and customer behaviour and the awareness of the need to work more efficient with reporting and analysing the side effects. Another is the political and regulatory affairs. Despite the move towards more reporting, sharing of information and global rollouts of new products, the regulatory regime is still in large parts both unaligned and non-transparent:
“Officially the global political goal is to align and unify the regulatory requirements, thereby optimizing the possibilities of developers of products within life science and health care to optimize their handling of PV. We are a bit ahead in the EU, despite being challenged by Brexit, but globally the process is very slow, uneven, and rather unpredictable. A constant monitoring is necessary, and I see it as central part of my work advising our clients to keep them informed about the changes and what they need to do to be prepared.”
Academic and Professional resume
Marc holds a Ph.D. in physics from the University of Cologne, Germany, entitled “Anomaler Hall-Effekt in dotierten Kobaltaten”.
Marc contributes to advance R&D IT through several networks such as DIA, Forum Institut and the Oracle Health Sciences Safety Consortium.
Prior to working at Insife:
Chief Quality Officer
2013 - 2021
Cologne Area, Germany
Life Science IT Consulting, with focus on Pharmacovigilance processes and Argus Safety.
Responsible for the pharmaSOL Quality Management System and Information Security Management System.
Definition and Monitoring of the company processes.
Consulting for Drug Safety Business Improvement Projects.
Implementation and Validation of Life Science Applications for Pharmacovigilance and Clinical Development.
Associate Director, Global Drug Safety Application Management
2009 - 2013
Responsibilities included Application Management, Business Intelligence and Business Process Engineering for the Global Drug Safety department. Project leader for Argus Safety upgrade and Empirica Signal implementation. Liaison to Global IT and deputy responsible for EudraVigilance.
Manager, Global IT Product Development
2003 - 2009
Responsibilities included the implementation and controlling of Service Level Agreements for GxP Applications, harmonization of validation processes and project controlling and the assessment of offshoring vendors for application support. Responsibilities included the implementation and controlling of Service Level Agreements for GxP Applications, harmonization of validation processes and project controlling and the assessment of offshoring vendors for application support.