Next events
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Please note:
- MediNeos free events (webinars and workshops) are exclusively reserved to MediNeos clients.
- Programs may be subject to changes. Please visit www.medineos.com/events for updates and registration links.

17 June 2020 (Workshop)

After the entry into force of European Regulation no. 679/2016, Italy has implemented local regulations that have an impact also on clinical and scientific research.

In the meantime, the new technologies  of Patient Support Program (PSP) generate new reflections on personal data protection.

The workshop aims to analyze European and local regulation framework that have impact on observational clinical research.

 

Speaker: F. Preite, lawyer

She obtained a law degree in 1994 and she is been practicing since 1997. She dedicates most of her work activities to business consultancy especially in the field of clinical research with particular attention to the Privacy legislation in epidemiological studies and management of clinical databases. On these issues she has published several contributions including some articles for the Italian Society of Medical Statistics and Clinical Epidemiology (SISMEC).

For more information and registration: training@medineos.com

The workshop is free and reserved to MediNeos clients


30 June 2020 (Webinar online)

While the wide-ranging subject of quality is perfectly well regulated in clinical trials, it still remains foggy in observational research because of some legal gaps that lead to frequent difficulties/doubts for specialized operators. During this webinar we will explore different views on this subject, bringing some specific situations related to Real World Data research and giving much room for discussion from the audience.

Speaker: Sara Montanari, MediNeos Quality Assurance Manager

She has competencies in genetics, clinical epidemiology, GCP, Patients Reported Outcomes, computer system validation, pharmacovigilance, quality assurance and quality compliance processes, and in laws and regulations applicable to the conduction of clinical studies.

The webinar is free and reserved to MediNeos clients


15 July 2020 (Webinar online)

The webinar will present guidelines for best practices in publishing and presenting scientific results, with a special focus on results from observational studies. It will cover the widely cited STROBE and CONSORT statements.

Speaker: Sara Rizzoli, Medineos Senior Biostatistician

She obtained a MS degree in Statistics and a Master in Communication and Information Technology (University of Bologna). In MediNeos she is responsible for writing study protocols (statistical analysis and sample size paragraphs), designing and validating the case report forms, for data analysis (statistical analysis plans, statistical and clinical study reports). She is author of scientific publications on international journals and of scientific communications both at national and international congresses.

The webinar is free and reserved to MediNeos clients


29 September 2020 (Workshop)

At the end of the workshop, participants will share indications and examples on how to approach in their own company a valuable method for designing a Real World Data collection dealing with internal multi stakeholders and with the high heterogeneity of observational research methods (prospective and retrospective study designs) and of the type of studies (registries, medical chart reviews, drug utilization studies, epidemiological studies, etc.).

Speaker: Daniele Andreis, MediNeos Epidemiology and Outcome Research Specialist

Graduated in Prevention, Health Promotion and Education. He has strong experience in clinical research having participated in over 50 clinical trials (phases I through IV) and coordinated multiple academic projects from start-up to close-out. Among his competences: expertise in research methodology, skills in designing observational studies, study protocol writing and results reporting. He is coauthor of more than 20 scientific publications.

For info and registration write to: training@medineos.com

The workshop is free and reserved to MediNeos clients


13 October 2020 (Webinar online)

The aim of this webinar is to provide a methodologic overview of the peculiarities and opportunities of observational studies on rare diseases. As the real-world research on rare diseases is persistently growing in demand, a general understanding of appropriate observational methods is recommended in order to approach this interesting and challenging epidemiologic area.

Speaker: Alessandro Zullo, MediNeos Clinical Project Portfolio Manager

The webinar is free and reserved to MediNeos clients


27 October 2020 (Webinar online)

Real World Data refers to the systematic and unbiased collection of data used for decision making that are not collected in conventional randomized controlled trials. At the same time, the patients’ perspective has never been more important in the evaluations of medical products and in effectiveness research. Patient Reported Outcomes (PRO) play a key role in capturing real world data that reflect patients’ needs and values. This webinar will provide an overview of PRO-related topics with a particular focus on the use of PROs for the collection of Real World Data for RWE generation.

Speaker: Daniele Andreis, MediNeos Epidemiology and Outcome Research Specialist

Graduated in Prevention, Health Promotion and Education. He has strong experience in clinical research having participated in over 50 clinical trials (phases I through IV) and coordinated multiple academic projects from start-up to close-out. Among his competences: expertise in research methodology, skills in designing observational studies, study protocol writing and results reporting. He is coauthor of more than 20 scientific publications.

The webinar is free and reserved to MediNeos clients


04 November 2020 (Workshop)

The workshop will be focused on main characteristics of Patient registries, with particular attention on some methodological aspects and main advantages. Some examples will also be provided and discussed.

Speaker: Fabio Ferri, Medineos Epidemiology and Outcome Research Specialist

Graduated in Biomolecular and Cellular Sciences at the University of Ferrara. He has skills in designing observational studies, study protocol writing, planning and implementation of statistical analysis in SAS, statistical reports and clinical reports, publication of results, and evaluation of psychometric properties of questionnaires. He is also lecturer in webinars and training courses on statistical and epidemiological methods.

To register write to training@medineos.com

The workshop is free and reserved to MediNeos clients


18 November 2020 (Webinar online)

The aim of this webinar is to share an introduction about what site management means in Observational Studies. We will define what site management is, because some overlaps in definitions are still quite common.Then we will illustrate the typical site management tools, with specific regard to the study dashboard recommended for study management. In the second half of the webinar we will describe the most commonly used indicators in site management with specific examples.

Speaker: Alessandra Ori, MediNeos Clinical operations Manager

She started her working experience with important medical device manufacturers and since 2005 Alessandra has been working in MediNeos. Throughout the years she has built competence in clinical epidemiology, Clinical Site Management GCP applications, national and international regulations applied to clinical research.

The webinar is free and reserved to MediNeos clients


02 December 2020 (Webinar online)

In real world observational research, two basic components of any study are exposure and outcome. In absence of randomization, bias occurs when  a measure of association between exposure and outcome is systematically wrong. Selection bias, misclassification and confounding are typical problems that must be faced by the researcher so that a causal unbiased association between exposure and outcome is estimated. Knowing and understanding these feared demons is the first step for fighting them, armed with the powerful  weapons of study design and statistical analysis.

Speaker: Fabio Ferri, Medineos Epidemiology and Outcome Research Specialist

Graduated in Biomolecular and Cellular Sciences at the University of Ferrara. He has skills in designing observational studies, study protocol writing, planning and implementation of statistical analysis in SAS, statistical reports and clinical reports, publication of results, and evaluation of psychometric properties of questionnaires. He is also lecturer in webinars and training courses on statistical and epidemiological methods.

The webinar is free and reserved to MediNeos clients

MediNeos – Right to the point of Observational Research
Real World Evidence | Outcome Research | PASS/PAES | Drug Utilization Studies | Comparative Effectiveness | Patient Reported Outcomes
Viale Virgilio 54/U, 41123 Modena, Italy | Tel. +39 059 88.60.134 +39 059 88.60.135 | www.medineos.com | training@medineos.com