Principi di Computer System Validation

L’evento avrà luogo il giorno 18 Febbraio 2020, dalle 8.30-18.00 in sala Arena in via Durando, 39 a Milano


Speaker: Dott. Francesco Abbate

  • Computer system validation general concepts
  • Validation Effort and Methodology – risk based approach – Client vs Supplier
  • Validation responsibility

2. Computer Validation Life Cycle

  • Validation lifecycle general scheme – Planning documents
  • Specification Documents
  • Testing Documents
  • Acceptance Documents

3. How to Maintain the Compliance Status

  • Change Management, control and methodologies
  • Periodic review, tools and methodologies
  • Periodic Maintenance of Computer System inventory
  • On-going procedures (Backup&Restore, Record Retention, Security, Use…)

4. ERES and Regulatory Requirements

  • Overview of Electronic Records and Electronic Signatures (ERES)
  • Different types of Electronic Record (input/output regulated/not regulated, permanent/not permanent)
  • Applicable Regulatory Requirements and System Configuration

5. Remediation Activities

  • Compliance Assessment methodology
  • User Rights Review
  • Examples of GAPs and Corrective Actions
  • Analysis of GAPs Solutions

6. Example of CSV approach applied to a real computerized system (e.g. ICE Advice Pharma)

For more info and details e-mail AdvicePharma at or call phone no. +390223992985

Digital for Clinical Day 2019

Accelerate Clinical Development with Digital Strategies

November 7, 2019 – 9AM/6PM

Sala Carassa Dadda – Politecnico di Milano, Milan (Italy)

The success of digital transformation in medical research and patient care requires a solid understanding of the two basic interacting components, namely “patient care” and “digital”, at all levels. This event is intended to be a moment of confrontation on the digital transformation in the field of patient care research and management.

The technologies and the digital environment offer many opportunities to identify the health needs of the population and meet them by providing better health care, from prevention and enhancement of behaviors in favor of health, to the study of therapeutic interventions, from clinical research to the administration of care, management of chronicity. As such, digital technologies have the potential to transform health services and care research so as to contribute to the objectives of the health system.

The results and outcomes of the digital transformation in this area will depend significantly on the quality of the process of integrating IT innovation. It will benefit the end users of digital health services, such as professionals, health users or citizens, as well as developers and distributors of digital health services, and governments through their regulatory bodies.

The whole process of development, production, financing, implementation and evaluation requires careful evaluation in this context; the event wants to address these issues with a panel of experts in the field.

9.00 AM
Digitalization of the healthcare industry
E. Lettieri, Full Professor at Politecnico di Milano

9.35 AM
Management of personal data in EU: a threat to patients?

N. Vanin, Data Governance and Information Security Head, TIM
10.00 AM
Research and patient care in the hospital of the future
C. Nicora, Direttore Generale Policlinico San Matteo, Pavia
10.25 AM
Coffee Break
10.40 AM
Access to healthcare technologies in the patient centricity era
G. Beccagutti, Value, Access & Policy Director, Medtronic
11.05 AM
Digital health solutions in real-world setting

N. Porrello, Real World Evidence Leader, Roche

11.30 AM
Round Table: “Market access and patient access to innovation”
L.Cottini, AFI/High Research CRO; A. Ferri, AdvicePharma
Invited experts M. Pinciroli, Vice President Market Access, LivaNova; M. Zibellini, Market access & Pricing, Regulatory Affairs Director, Chiesi; F. Vallana, Chief Scientific Officer, CID-Alvimedica; D. Bonifazi, President, AICRO; F.Patarnello, VP Market Access & Government Affairs, Astrazeneca; G.. Tarantini, President, GISE.
11.05 AM
Lunch Break

2.00 PM
e-devices for patients monitoring
E. Caiani, Professor eHealth and Bioengineering, Politecnico di Milano
2.25 PM
Impact of mobile-health data on patient management
O. Ciani, PhD, Associate Professor of Practice, SDA Bocconi Milano

2.50 PM
Paving the future of clinical research with digital solutions

C. Tomino, Research Consultant – IRCCS San Raffaele Roma

3.15 PM
Coffee Break
3.30 PM
Standardized management of biological samples and data storage
G. Saltini, Quality Assurance Manager , BioRep, Gruppo Sapio
4.05 PM
Digital cohorts for virtual clinical trials: collecting and preserving data and biosamples to answer medical questions
R. Fesce, Full Professor of Physiology – Dept. Biomedical Sciences & NeuroCenter, Humanitas Medical School

4.30 PM
Round Table “Digital healthcare: opportunities and challenges”

Coordinators: M. Beccaria, Alfa TI; E. Sfreddo, Fondazione From

Invited experts:
G. Recchia, SmithKline Found, daVinci; L. Bergamini: Medical Affairs Director, Janssen-Cilag SpA; A. Ravizza, Founder, USE-ME-D srl – Member of the Board, BioPmed; E. Damiano, Commercial Operations Manager, Otsuka Pharmaceutical Italy; 
 G. Gussoni, Scientific Director, Centro Studi FADOI.

Modulo di iscrizione

Symposium Research 4.0 #AI4RCT

Artificial Intelligence and Clinical Trials Implications for Patients, Investigators, Institutions

30 Novembre 2018
Sala “Epson”, Politecnico di Milano – via Giovanni Durando, 39, 20156 Milano

30 novembre 2018 – Automation and information technology have redefined many aspects of our lives, it is therefore not unexpected that major technology companies are investing in the development of Artificial Intelligence (AI) for healthcare and research. AI technology, combined with big data, hold the potential to solve many key clinical trial challenges. These include increasing trial efficiency through better protocol design and study management.
Data-driven protocols and strategies powered by advanced AI algorithms, processing data collected from mobile sensors and apps, electronic medical and administrative records, and other sources have the potential to reduce trial costs. We are therefore witnessing the development of what we would call Smart Research Engineering.
Nevertheless, the extensive adoption these innovations does present technological and ethical challenges. These will be among the subjects debated during this workshop, with a panel of experts in the field.


2.00 pm Welcome and Opening Remarks Stefano Mainetti
2.15 pm Where were we? Videosummary for the 18.9.2018 meeting Massimo Beccaria, Giuseppe Recchia
2.30 pm #AI4RD Artificial Intelligence and Research of new medicines Antonio Pelliccia
3.00 pm #AI4RCTs Artificial Intelligence and Clinical Trials Francesco Tenuta
3.20 pm Artificial Intelligence to discover and develop new medicines: Patients’ Fears and Expectations Luca Patelli
3.40 pm Artificial Intelligence to discover and develop new medicines: Investigators’ Fears and Expectations Eugenio Santoro
4.00 pm Artificial Intelligence and Clinical Trials: implications for the Hospital and the Research Site Carlo Nicora
4.20 pm #ELSI Ethical, Legal and Social Implications of Artificial Intelligence in health research Pietro Refolo
4.40 pm Machine Learning and Digital Therapeutics #DTx Duilio Macchi
5.00 pm #AI4ICE – A new Artificial Intelligence system for Clinical Trial Optimization Davide Tarantola
5.30 pm Panel Discussion and Q&A Session Prepare for the Intelligent Trials: #AI comes to Clinical Trials Giuseppe Recchia, Massimo Beccaria, Enrico Caiani, Duilio Macchi, Carlo Nicora, Luca Patelli, Antonio Pelliccia, Pietro Refolo, Eugenio Santoro, Davide Tarantola, Francesco Tenuta 6.30 pm Chairmen’s Conclusions G. Recchia, M. Beccaria



European Statistical Forum

Novembre 12, 2018 – Advice Pharma con ICE eCRF tra gli sponsor del European Statistical Forum – 12 Novembre 2018 a Copenaghen. Un’intera giornata dedicata alla “Innovazione nella progettazione delle sperimentazioni cliniche” e un seminario di pre-conferenza progettato per approfondire la conoscenza di “Gestione della molteplicità dei progetti clinici innovativi”.

Pharmacovigilance Day

November 7, 2018 – Advice Pharma con ICE eCRF tra gli sponsor del Pharmacovigilance Day
Wednesday, November 7th, 2018 Rome, Italy

Una nuova era per la Farmacovigilanza?
Mentre continuano le implementazioni e le revisioni nell’ambito della farmacovigilanza, è ovvio pensare che il 2018 passerà alla storia come l’anno della sua metamorfosi.

  • Brexit
  • operatività a regime del nuovo EVWEB/EVDAS
  • ridotte funzionalità della RNF
  • arrivo del nuovo regolamento europeo sulla privacy
  • nuovo regolamento europeo sulle sperimentazioni
  • era digitale in rapida evoluzione
  • sistemi qualità globali finalizzati alla sicurezza dei pazienti
  • qualità dei prodotti e integrità dei dati

sono alcuni degli “hot topics” che verranno discussi all’Italian Pharmacovigilance Day. L’evento sarà strutturato in modo trasversale toccando diverse figure professionali, non solo propriamente operanti in PV ma anche in ambito Quality Assurance, Privacy, Regulatory Affairs.
La conferenza avrà un approccio teorico pratico e gli interventi, oltre ad avere un taglio prettamente di farmacovigilanza, includeranno aspetti strategici/tattici/operativi.
Si prevedono momenti di presentazione congiunta tra professionisti di PV e altre figure professionali che sono implicate e che toccano aspetti legati alla “safety”.
Saranno evidenziati i diversi punti di vista e suggerite le possibili “lean standards” condivise e conformi.

Un particolare focus sarà posto sulle implicazioni organizzative e i processi aziendali, una rivoluzione dovuta a diversi aspetti tra i quali:

  • ricollocazione Agenzia (EMA) e gli impatti sulle attività regolatorie con l’Agenzia
  • eventuale ricollocazione EUQPPV, PSMF e riorganizzazione dei ruoli professionali di PV HQs e Filiali/Sussidiarie
  • aree di “overlapping” delle GVP nelle GxP
  • vecchi e nuovi aspetti di PV negli studi interventistici/ non interventistici e data privacy
  • il mondo dei “digital media”

La platea sarà chiamata ad essere parte integrante della discussione e ci aspettiamo che quest’anno il “ring” sarà molto caldo

39th GISE Congress

Advice Pharma tra gli sponsor del 39° congresso GISE – 16-19 Ottobre a Milano.

Ogni anno si svolge il Congresso Nazionale GISE che riunisce i Soci e rappresenta il principale momento associativo, dedicato anche all’elezione dei rappresentanti dell’associazione e all’approfondimento dell’Emodinamica e della Cardiologia Interventistica. L’elevato spessore degli interventi scientifici, la qualità dei casi clinici presentati e l’intensità del dibattito che caratterizzano tutte le sessioni del Congresso lo rendono il più importante evento del mondo della Cardiologia Interventistica in Italia.

European Epidemiological Forum

October 8, 2018 – Advice Pharma with ICE eCRF is among the sponsors of the European Epidemiological Forum in Zurich. The event organized by LS Academy this year will be dedicated to the use of Real Word Evidence to improve clinical programs and patients’ lives.

Artificial intelligence and clinical research

September 18, 2018 – from 8.30 to 13.30
Carassa-Dadda” Great Hall
Politecnico di Milano – via Raffaela Lambruschini, 4 20156 Milano

The fourth industrial revolution is in full swing and is deeply involving health care models, directing them towards digital transformation.

In medicine, the use of Artificial Intelligence (AI) is allowing a change of approach aimed at achieving unprecedented customization and precision in treatments, therapies and administration of drugs, as well as in the use of biomedical devices. When we talk about the use of AI in the study of new therapeutic approaches, we think about how this can simplify the complexity of research projects and the development of new products. To understand the potential of AI in the specific field of clinical research, a group of experts will analyze in an interactive symposium the impact and benefits that it will be able to bring in this specific field of medicine.

Who is it aimed at?

The event is aimed at managers of the pharmaceutical industry, medical devices and health professionals working in the field of research and clinical trials.


8.30 Welcome and introduction to the event
What impact will AI have on clinical research and experimentation in the next 3 years?
Massimo Beccaria – Managing Director Alfa Technologies International
Giuseppe Recchia – Vice President Medical Scientific, GSK

8.55 What do we mean by IA…
everything you wanted to know and never dared ask.
Matteo Matteucci – Associate Professor at Politecnico di Milano Lecturer in Robotics, Cognitive Robotics, and Machine Learning

9.20 We use Intelligence in the use of AI.
Roberto Fantino – President of NAT Style

9.45 New fields of application of the IA in research and health.
Enrico G. Caiani – Associate Professor at Politecnico di Milano, Chairman of WG e-Cardiology European Society of Cardiology, Professor of eHealth and Bioengineering

10.10 Coffee Break

10.25 Decision Support Technologies and Clinical Research Assistants.
Gorgio Manfredi – CEO Rumbletumbleweed, CEO Occambee, Founder Forever Identity Inc., ISMC Advisor

10.50 AI integrated in medical devices, practical applications.
Maurizio Viviani – CEO Strong Artificial Intelligence, San Francisco

11.15 Implementing business processes with Cognitive Computing
Strategic roadmap for the adoption of IA in the pharmaceutical sector
Ettore Murciano – VP Channel Sales and Alliances, Loop AI Labs Inc. San Francisco

11.40 The IA at the service of clinical trials and medical research
Eugenio Santoro – Head of the Medical Informatics Laboratory, Mario Negri Institute for Pharmacological Research – IRCCS

12.15 New technologies for research, when to innovate.
Sergio Scaccabarozzi – Head of Country Clinical Operations-Italy, Roche

12.40 Round table and discussion with the rapporteurs

13.30 Conclusions

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58th AFI Symposium

June 6, 2018 – The AFI Annual Symposium, now in its 58th edition, focused on the ongoing changes in the activities of the drug industry as a result of new digital technologies.

Among the speakers, Massimo Beccaria, managing director of Alfa Technologies International (spin-off of Advice Pharma), presented the developments of artificial intelligence applied to clinical trials.

Beccaria explained how AI intervenes during the management of a project by supporting the operator to prevent human error, increasing access to data and simplifying the management of decisions. The results are a significant reduction in errors, costs and decision-making times and a simplification of processes.

The project, advanced by Advice Pharma, involves the creation of an avatar that will support all stages of research. It will provide researchers with immediate access to a network of useful information and data.

Link to the video of the intervention

ePharma Day

Advice Pharma with ICE eCRF among the sponsors of ePharma Day, May 16, 2018 in Milan

Clinical research 2.0: Strategic, organizational, infrastructural and quality aspects.

The world of clinical research is in a phase of profound transformation. The acceleration of scientific knowledge in recent years is leading to an exponential increase in the number of clinical trials with new drugs. This increase in studies is associated with a profound methodological transformation, which leads to overcoming, thanks to adaptive designs and approaches “basket- and “umbrella trials”, the classic model of development based on sequentially managed phases for individual New Chemical Entities.

In order to ensure rapid access to new drugs for patients and to contain high development costs, the regulatory authorities, FDA and EMA, are willing to accept new approaches ranging from new experimental designs, to early access models, to the management of certain aspects of development with a “risk based” approach, up to the opening of the future use of Real Word Evidence data.

In this context, operators involved in the management of clinical research are faced with major new challenges.

  • What is the evolution of skills, processes and tools in pharmaceutical companies, CROs and research centres, also in view of the regulatory changes taking place?
  • What organisational changes will we have to face and what are the priority areas?
  • How much will the technological evolution affecting the world of health care influence the way clinical research is carried out?
  • What is the point of view of doctors, study nurse, research coordinators and data managers who work in this sector and who are experiencing this transformation?
  • What is the right balance between complexity, speed and quality to make the Italian system more competitive at European level?

Antonino Amato, Managing Director of Clinical Trial Center SpA, a subsidiary of Fondazione Policlinico Universitario A. Gemelli; Paolo Morelli, CEO of PM Holding; Simona Re, Clinical Operations Therapeutic Area Leader Oncology and Hematology of Roche SpA and Sergio Scaccabarozzi, Head of Clinical Operations of Roche SpA, scientific coordinators of the event, will lead a panel of experts in order to share best practices, results and experiences in this field.