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AIFA: a research-driven Coronavirus Task Force

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A strategy for the fight against Coronavirus in which the promotion of clinical trials, with the parallel collection of data necessary for the purpose, is one of the building blocks that make up the action plan of the Agenzia Italiana del Farmaco (AIFA – Italian Medicines Agency) .

As highlighted by AIFA itself in a press release published on its website, a crisis unit has been set up on four fronts: drugs in off-label use; research and development/access to experimental drugs; national management guidelines; and the fight against shortages of medicines at hospital level.

The Ministry of Health also recognised the need for this plan last week. “The vaccine will be the ultimate weapon – said the Minister, Roberto Speranza -. In this world match Italy is with all our scientific community, in a relationship of full collaboration with pharmaceutical companies”. But Speranza also stressed that the measures to manage the COVID-19 emergency are moving to date on the four levels identified by the Agency.

Promotion of clinical trials and off-label use. The evolution of trials

It is mainly on the research front that the most obvious needs have emerged. AIFA has in fact underlined its role in “evaluating all clinical trials on medicines for patients with COVID-19”. In this regard, with the help of the Scientific Technical Commission (CTS), it has activated a “simplified procedure that aims to promote, regulate and supervise access to therapies potentially useful to combat this pandemic”.

In this simplified management of clinical trials, the Agency has prepared an updated list of ongoing trials, but also a list of drugs used outside clinical trials. The National Health Service (by way of derogation from Law 648/96) has therefore included the off-label use of medicines registered and approved for the use of different pathologies. Among these are chloroquine, hydroxychloroquine (two antimalarial drugs with preliminary data on potential antiviral activity); as well as lopinavir/ritonavir and, subordinately to the latter, darunavir in combination with cobicistat or ritonavir (drugs used to treat HIV infection). To these are added the antiviral Remdesvir and the monoclonal antibody Tocilizumab. “Other experimental protocols, both independent and proposed by pharmaceutical companies, are being evaluated, with further therapeutic alternatives that could represent new options”, reads the AIFA website.

The “management” factor and the creation of a Task Force

The other two lines of the AIFA strategy concern the management of the phases necessary to ensure the start of the research. Already at the beginning of last month, the Agency stated that it has started a series of actions to “combat shortages of medicines”, facilitating the import of critical products through contact with marketing authorisation holders (MAHs) and importers to ensure the regularity of supplies of medicines used at hospital level during the emergency. But all this takes place under the lens of the control booth which sees the participation, alongside AIFA, of the Civil Protection and the National Institute for Infectious Diseases Lazzaro Spallanzani (INMI), national reference centre for research and treatment of infectious diseases and WHO Collaborating Centre for highly contagious diseases. This task force has the task not only to develop national management guidelines for COVID-19 cases, but also to follow the progress of clinical trials and to provide all available information on ongoing trials.

Principi di Computer System Validation

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

WORKSHOP AGENDA

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 gehad.shehata@advicepharma.com or call phone no. +390223992985

Milano for Covid, superare la pandemia con un approccio multidisciplinare

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a project multidisciplinare, intellettualmente laico e collaborativo. È quanto portato avanti da “Milano for Covid – Uniti per informare”, l’iniziativa promossa dal dottor Eric Manasse e che coinvolge un team composto da 40 esperti in differenti ambiti: sanità, economia e ricerca, industria e ambiente, area legale e sicurezza informatica; nato con l’obiettivo di generare analisi, creare report e informare cittadini e istituzioni.

La squadra di Milano for Covid intende offrire un approccio polisettoriale al superamento dell’emergenza innescata dalla pandemia Covid-19. Tra gli obiettivi, in particolare, il contributo della comunità scientifica per l’avvio e la costruzione di nuovi modelli e dinamiche comunicative volte a veicolare contenuti certi, ideologicamente “laici” e tempestivi. E perché ciò avvenga è necessaria una visione “omnicomprensiva e multidimensionale in grado di elaborare analisi, informazioni e proposte chiare, a beneficio di chi decide e dell’intera collettività”.

«Milano for Covid è la dimostrazione che la muldisciplinarietà è la base della crescita collettiva», sostiene Alessandro Ferri, Managing Director di AdvicePharma tra gli esperti coinvolti nell’ambito Economia e Ricerca. «Il contributo fornito da ciascun professionista, sotto la guida del dottor Manasse, è una spinta a superare l’individualità delle proprie competenze e dei propri ambiti di attività, per raggiungere un obiettivo comune, quello di una società non soltanto “sana” ma anche “consapevole” e “informata”».

Come riportato sul sito, il gruppo di lavoro “Uniti per informare” abbraccia nove macro discipline e altrettante nazionalità fra i propri membri, e intende avanzare proposte concrete applicabili in diverse aree: la definizione di un nuovo piano di emergenza pandemico, fondato su un sistema decisorio centralizzato e in grado di abbracciare tanto gli ambiti medici e sanitari, quanto quelli legali e comunicativi; la creazione di una nuova relazione fra pubblico e privato, in cui l’Unione Europea si configuri come soggetto autorevole in grado di agire nell’interesse di tutti gli Stati membri, armonizzandone le differenze e valorizzandone le peculiarità; lo sviluppo di nuovi modelli di business che guardino alla società nel suo insieme, alle sue componenti più deboli e alle generazioni future; una spinta definitiva verso la digitalizzazione, estesa all’intera società attraverso una formazione capillare e infrastrutture all’altezza dei nuovi flussi di dati. Il tutto dando nuova centralità al settore medico che, anche nell’emergenza Covid-19, si è dimostrato vera guida socio-scientifica nei Paesi colpiti. E questo anche attraverso la creazione di cluster che lo rendano sempre più autonomo e indipendente.

Digital for Clinical Day 2019

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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.

Symposium Research 4.0 #AI4RCT

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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.

Agenda

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

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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

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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

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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

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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

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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.

Agenda

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

Source link: https://lsacademy.com/it/corsi/intelligenza-artificiale-e-ricerca-clinica/

To register, please fill in the following form