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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.

4 May 2018 – Advice Pharma participates in the Thinkhart with GISE event.

The third edition of ThinkHeart with GISE will take place on May 4, 2018 at the Auditorium Via Veneto in Rome. It will be a limited number event, during which will be presented a preview of the data of diagnostic and interventional cardiology activities 2017 and the main barriers of access in Italy, compared to other European countries, to therapies of proven effectiveness in terms of mortality and morbidity, innovative medical technologies or still not widespread in the Italian context.

The aim of ThinkHeart 2018 is to identify, thanks to institutional and professional stakeholders, scientific societies and research bodies, governance processes and a shared agenda that can ensure appropriate access to innovative technologies in Italy. A summary document, a roadmap, representing the commitment of all the experts involved in the implementation of the actions identified, will then be shared.

European Data Protection: news in the pharmaceutical and health field Organized by Advice Pharma Group in collaboration with LS Accademy On March 6, 2018, at the Polihub Bovisa – Politecnico di Milano, Milan

The event focuses on the discussion on the changes brought about by the new General Data Protection Regulation (Gdpr), legislation with which the European Commission intends to strengthen and unify the protection of personal data within the borders of the European Union. The objective of the EU is to substantially modify several aspects of data collection, processing and retention. All companies within the EU will also have to adapt to the new rules on the processing of personal data, the management of information security and compliance processes and contractual relations. During the event organized at the PoliHub, the business incubator of the Politecnico di Milano, the following topics of the legislation will be discussed: structure, principles, impacts on the organization, on the IT sector and on the management of clinical research; Data Protection Officier, Data Protection Impact Assessment, certifications, extra-EU data transfer, sanctions, etc.

February 22-24, 2018 – Advice Pharma is among the sponsors of the 12th Meeting Cardio LUCCA

The labyrinth between science and assistance. Lucca, 22-24 February 2018

The heart of Lucca is ready to beat, once again and even stronger. From Thursday, February 22 until Saturday, February 24, the auditorium of San Francesco will host CardioLucca 2018, the traditional meeting expression of the precious scientific and organizational heritage of cardiology in Lucca.

Organized by Advice Pharma Group in collaboration with Alfa Technologies International

On 28 November 2017, at the Polihub Bovisa – Politecnico di Milano, Milan

Speed in data collection and aggregation of information and cost reduction. These are the basic requirements for being competitive in conducting clinical studies. And that’s what Ice (Integrated Clinical Trial Environment), a new platform for clinical data collection created by Advice Pharma, does. The workshop organized at the PoliHub, the business incubator of the Politecnico di Milano, brings together experts from the public and private sectors to discuss the advantages and opportunities of using this innovative solution.

Every year the National GISE Congress takes place, which brings together the members and represents the main association moment, also dedicated to the election of the representatives of the association and to the in-depth study of Hemodynamics and Interventional Cardiology. The high depth of scientific interventions, the quality of clinical cases presented and the intensity of debate that characterize all sessions of the Congress make it the most important event in the world of interventional cardiology in Italy.

The IX BIAS Congress will be held in Parma on 28 and 29 September.  For this edition, the BIAS Committee has chosen to broaden the horizon and has developed a program that will embrace topics of growing interest to those working in clinical research.

The Society of Associated Biometricians of the Industry (BIAS) was founded in 1985 as a working group SSFA (Society of Applied Pharmacological Sciences) with the aim of deepening issues related to statistical methodology in clinical and pre-clinical trials.

Advice Pharma organized the first ICEVENT in 2017, hosting representatives of industry and public service at the INTERACTIVE WORKSHOP ON eCRF-BUILDING WITH ICE on July 26, 2017, at the Sala Arena, Polihub Bovisa – Politecnico di Milano.

Advice Pharma is among the sponsors of Nordic ePharma Day – Copenhagen, May 31 2017.

The LS Academy event for the Nordic countries. Dedicated to European clinical research legislation and its impact, with the title of this year’s ePharmaDay event being Implementation of Clinical Trial Regulation EU 536/2014 and National adoption. What lies ahead: Impact on Clinical Trials and Stakeholders.