LIMS has no boundaries over the Cloud

This November 25th from 10 AM to 12 PM join us for a very special free online event!

Main topics

  • check mark Regulatory Challenges for Cloud based solutions
  • check mark GDPR & new technologies: Obstacles or Opportunities?
  • check mark Eusoft.Lab the LIMS saas for Pharma
  • check mark SaaS Solutions: Pros and Cons from the Regulated User perspective

Agenda

  • 10.00 — 10.05   Introduction
  • 10.05 — 11.30   Main topics presentation
  • 11.30 — 11.55   Q&A section
  • 11.55 — 12.00   Conclusions
Hosted by
logo PQE Group + payoff-1
Eusoft

Boost your Data Management System

Cloud based solutions are widely used in nowadays industry, as the digital transformation helps major firms to further push their businesses.
This includes managing overwhelming amounts of Data, and Pharma Companies’ environment makes no exception.
Delivering protection and integrity to GxP Data, as well as making each involved workflow consistent and secure, it’s one of the major concern in this environment.
This can be achieved through a tailored Validation Lifecycle for each computer and/or process system, including a well assessed risk based approach, together with the system provider qualification, and the drafting of service and technical level Agreements.
However, in light of above, the implementation of cross-linked systems to manage analytical data and QA functions, such as a LIMS SaaS (Software as a Service), maintained and accessible within a cloud based platform, can be a huge boost to the firm’s business core in terms of Data management in a sleek yet compliant way, and is a ‘must have’ to get your Pharma company fly high.

The right infrastructure and a proper Validation lifecycle for the Service will give a real chance to also have custom controlled measures in order to ensure these systems a proper and safe usability in the future.

LIMS-illustration

Introducing the Team

Danilo-Neri-resized

Danilo Neri
Speaker

VP Executive, Senior Partner
& Data Integrity Principal Consultant

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20+ years of experience in managing multi-site, international projects for MES, ERP and Serialization System Validation. Graduated with a degree in Physics and a PhD in Engineering, Danilo Neri is a Principal Consultant with a demonstrated history of working in the pharmaceuticals industry and certified PDA Auditor in Computer Products Supplier Auditing Process Model since 2003.
Member of PQE Group Board & Partner since 2004, he is now the Vice President Executive of the company.

Massimo Marino

Massimo Marino
Speaker

Co-Founder & Senior Consultant

kax-consulting

MM has over 17 years of experience in scientific research and over 15 years in the private sector of cross-industry experience in providing Business Development, IT Governance, Data Privacy, Data Protection, Information Security & Risk Management leadership and guidance to international companies. He worked at CERN, the Lawrence Berkeley National Laboratory in California (USA), Apple Computer Inc, and the World Economic Forum, Advanced Accelerator Applications, and Novartis. At CERN, he was one of the pioneers of Object Oriented development techniques applied to HEP software applications in the early 90s. Massimo has defined, implemented, and realized whole GDPR compliance programs and strategies, trained operatives in all aspects of the regulation which impacted business operations.
In 2020 Co-Founds KAX Medical, Pharmaceutical, Information Security and Data Protection Consulting Sarl.

Stefano dAscoli Eusoft

Stefano D’Ascoli
Speaker

CEO

Eusoft

More than 20 years of experience in ICT with a specific focus in the development of highly innovative software solutions for quality control and laboratory management.
Graduated in Sciences of Information, Stefano D'Ascoli founded Eusoft in 1997 and is currently the CEO of the company. In 2015, after the international growth of the company, Eusoft Ltd reached the UK.
Creator of Eusoft.Lab, the first italian LIMS Saas cloud solutions for laboratories' management and quality control.

Claudia Martini Dompé

Paola Martini
Speaker

Corporate Quality System Specialist

dompe

Paola is a pharmaceutical biotechnologist with about 10 years of experience in cGxP biopharmaceutical environments with area of expertise in quality assurance and regulatory.
Paola is a Corporate Quality System Specialist at Dompé Farmaceutici S.p.A. She has in-depth understanding of computerized system validation, infrastructures, digitalization and serialization processes. Paola is also a Corporate Quality SME for data integrity topic. She understands FDA, EU and Russian regulations, regulatory guidance documents, and ICH guidelines and has applied the knowledge to develop risk-based approaches for several applications. Paola is a certified auditor and has significant experience in GxP compliance auditing.

Davide Bottalico

Davide Bottalico
Moderator

Digital Healthcare & Innovation Head

takeda

Davide Bottalico, Nephrologist, born in Piacenza (Italy) in 1966. Digital passionate, after 10 years as Medical Director for Haemodialysis centers, joined Pharma companies (Roche Diagnostics; Roche; Takeda) covering several positions in Medical Affairs and Digital Health. In 2012 created the 1st Pharma Digital Academy powered by IULM University of Milan winning the 4th  Social Media Pioneer Award in USA. He won the IAIR Award for 4 years in a row (2016-2019) as Excellence of the Year for Digital Innovation in the Pharmaceutical Industry. He was appointed in 2019 as Innovator of the Year by Popular Science Magazine. Among the innovative solutions he devised we mention LeggoXTe, the first solution equipped with artificial intelligence that allows the assisted consultation of the package information leaflets (PILs) of drugs through Google Home and Amazon Alexa; ScaNews the first anti-fake-news App for the world of Health; Virtual Lab, the first immersive virtual laboratory for the cultivation of stem cells for therapeutic use and MyHospitalHub PRO the advanced telemedicine platform that also allows the management of Smart Homes for monitoring fragile elderly patients at home. Recently in 2021 he won the W.In.e prize as eLeader in Healthcare during the Digital Health Summit held in Milan.