Eventi

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

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.

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”.

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

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.

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.

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

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.