On Thursday 25 January 2024, we organised the Webinar “ISO IDMP standard: a challenge for pharma companies to comply with EMA requirement”, with the participation of our Arithmos experts, Sergio Scaccabarozzi and Maurizio Giraudo, and some important Life Sciences companies, that shared their direct experiences.
The Webinar was full of insights and insights. We are pleased to share the recording of the Webinar:
About the Webinar
To allow a facilitated and reliable exchange of medicinal product information robustly and consistently, EMA has implemented a standards approach to handle four domains of master datain pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) master data.
This is intended to ensure wide interoperability across global regulatory and healthcare communities, which is critical in ensuring accurate analysis and unambiguous communication across different parties involved.
Starting from 2022, EMA has revised the process introducing a web-based approach, new functionalities, and requirements.
During the webinar, we will present and discuss:
- the principles of ISO IDMP classification (including Implementation Guidelines)
- EMA requirements
- Implementation process
- And the challenges for pharma companies
Structured and unstructured information management will be deep-dived to understand possible solutions approaches.
The experiences of some pharmaceutical companies will also be illustrated. Further details will be available soon.
What will you learn during the Webinar?
The webinar will provide you with useful information to better manage IDMP-related activity to comply with regulatory requirements.
Who is the Webinar for?
This webinar is addressed to people involved in regulatory information management, document management, and IT, in pharma companies. Depending on company’s organisation, they could mainly (but not limited to) people from regulatory, R&D, drug safety, drug manufacturing, and IT.
With a medical degree and a specialization in general surgery from Università degli Studi in Milan, Sergio Scaccabarozzi has 35 years of experience in Clinical Research for global pharmaceutical and biotechnology companies.
In his professional life, Sergio spent 12 years as Head of Clinical Operations for the Italian affiliate of a big pharma and biotechnology company, managing a team of 90+ people and more than 220 studies from Phase I to Phase IV, RWE and providing support to institutions for Investigator initiated studies.
Sergio Scaccabarozzi enriched his professional experience by spending one year and a half as Operation Research Manager in one of the most important public research hospitals in Italy.
Sergio Scaccabarozzi is a member of scientific societies and working groups on Clinical Research, a recognized speaker at national and international events, with active editorial activities on Clinical Research and Life Science in general.
With a law degree from La Sapienza University in Rome, Maurizio Giraudo is a management consulting professional with over 20 years of experience in Life Sciences from commercial excellence and digital transformation to R&D, regulatory affairs and manufacturing for global pharmaceutical, biotechnology, and medical device companies.
His career also boasts consulting experience with Accenture and EY, with a combined 14 years as a senior consultant and manager in the Life Sciences divisions.
Daniele Segagni covers the role of Corporate R&D Business Solution Manager at Menarini Group which means leading IT projects in the Research and Development field of pharma and life science, covering the space of drug discovery, chemical development, pre-clinical and clinical development, regulatory affairs, including also pharmacovigilance.
He has been working with R&D experts for about 15 years in research centres and international and Italian pharma companies.
As Business Solution Team head, he leads initiatives aimed at developing strategies by anticipating, identifying, and articulating new business needs or exploring ways for adoption of new technologies like Artificial Intelligence, shaping demand, design capabilities, planning activities for building new solutions that can make the difference for R&D stakeholders.
A technologist and business development professional whose experience spans 39, 8 years initially as a Software Engineer and most recently 31 years dedicated to the Life Sciences industry. In his current role he leads Veeva System’s strategy activities in Europe for their Regulatory customers to help them leverage their innovative Vault RIM product suite.
Previous roles have also included Business Development, Product Management, Product Architecture, Software Development and Professional Services at DxC, CSC and FCG.
We are experts in the Life Sciences industry & Technology.
We support pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions and achieve excellence in business operations.