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.

05 February 2019 (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.

Click here to register

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


14 February 2019 (Webinar online)

Starting with a few common definitions, the webinar will give insights about how to plan and manage patient registries from both a methodological and a statistical point of view. We will also describe types and benefits of patient registries and studies derived from them.

Speaker: Christian Amici, MediNeos Clinical Project Portfolio Manager

After graduating in Pharmaceutical Biotechnology, he obtained a master’s degree in International Health Care Management, Economics and Policy at Bocconi University (Milan). He began his work experience in MediNeos in 2009 as Clinical Research Associate and later as a Study Designer. Since 2014 he has covered the role of Clinical Project Portfolio. Christian has a consolidated experience in: observational research, international and local project management and account, public speech and epidemiology

Click here to register

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

 


21 February 2019 (Workshop)

Conducting a real world data collection applying observational research methods implies to find the best tool to answer a strategic need in the framework of a company project. The workshop aims to focus the attention of participants on the importance of sharing with all the internal stakeholders a preliminary clear definition and description of the project goal related to an observational research before starting the design of a study protocol.

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: Giovanni Fiori, Medineos Scientific and Managing Director

He has an academic background in epidemiology and human populations biology. His current main scientific interests are clinical epidemiology (innovative study designs and analytical methods)and outcome and health services research. He is the author of several scientific publications and lectures both at national and international congresses.

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

The workshop that will be held in Rome from 2pm to 5.30pm is free and reserved to MediNeos clients


07 March 2019 (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.

Click here to register

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


21 March 2019 (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 - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


02 April 2019 (Workshop)

Since their first regulatory definition issued on 2010, Post-Authorisation Safety Studies have been confirmed as one of the main tools required by regulatory agencies (EMA) to support the evidence of the drug safety. Discussing the regulatory evolution and the use of observational research methodology in this context, the workshop aims to highlight the key factors that may transform a regulatory need into a successful opportunity to fill significant data gaps.

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.

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

The workshop that will be held in Milan from 2pm to 5.30pm is free and reserved to MediNeos clients

 

 


11 April 2019 (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.

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


09 May 2019 (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 - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


23 May 2019 (Webinar online)

The webinar content spans from the main definitions of frequently used terms to the real-life examples of Observational Research deployment at various stages of the drug life-cycle. It will provide the participants with basic knowledge on ‘hows’, ‘whens’ and, perhaps most importantly, ‘whys’ of this particular kind of evidence generation.

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


06 June 2019 (Webinar online)

The promise of Real World Evidence is that a rich diversity of data collected from extremely large samples of patients will yield more precise, better targeted and thus more highly effective health care at the level of the individual patient. This promise is driving current research methodology towards a massive use of secondary data sources, that is, sources comprised of data originally collected for other purposes (ex. other studies, registries, standard medical care, administrative databases, etc). This tendency opens doors to a rejuvenated use of retrospective observational research. Retrospective methods are gradually improving their reliability in order to embrace the current challenge of supporting robust Real World Evidence.

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

 


12 June 2019 (Workshop)

EU has introduced rules on data protection with the objective of harmonizing the various local regulations and to facilitate the free movement of data, in balance with the protection of the rights and dignity of individuals; first notes relating to this balance in the clinical research. In this workshop, it will be highlighted what has been the impact of GDPR for the observational 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 that will be held in Rome from 2pm to 5.30pm is free and reserved to MediNeos clients


20 June 2019 (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

He has a scientific background in biotech and rare disease with a strong experience in observational research. He is working in MediNeos since 2009 and currently covering the Clinical Project Portfolio Manager position

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


03 July 2019 (Course)

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 - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


12 September 2019 (Webinar online)

The webinar will provide an overview of the regulatory framework applicable to the conduction of an observational PASS study. Attendees will be given indications on mandatory and recommended provisions on the design of an observational PASS study.

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 - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


26 September 2019 (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: Christian Amici, MediNeos Clinical Project Portfolio Manager

After graduating in Pharmaceutical Biotechnology, he obtained a master’s degree in International Health Care Management, Economics and Policy at Bocconi University (Milan). He began his work experience in MediNeos in 2009 as Clinical Research Associate and later as a Study Designer. Since 2014 he has covered the role of Clinical Project Portfolio. Christian has a consolidated experience in: observational research, international and local project management and account, public speech and epidemiology

To register write to training@medineos.com

The workshop that will be held in Rome from 2pm to 5.30pm is free and reserved to MediNeos clients


17 October 2019 (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 - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


29 October 2019 (Workshop)

Among the topics of the workshop:

- definition on site management within the context of Observational Studies

typical site management tools

- the study dashboard: tool recommended for study management

- most commonly used indicators in site management

Speakers:

Alessandra Ori, MediNeos Clinical operations Manager

Lucia Simoni, MediNeos Clinical Data Management and Biostatistics Unit Manager

 

To register write to training@medineos.com

The workshop that will be held in Milan from 2pm to 5.30pm is free and reserved to MediNeos clients


07 November 2019 (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 - that will be held at 3pm (CET) - is free and reserved to MediNeos clients


21 November 2019 (Webinar online)

Starting with a few common definitions, the webinar will give insights about how to plan and manage patient registries from both a methodological and a statistical point of view. We will also describe types and benefits of patient registries and studies derived from them.

Speaker: Christian Amici, MediNeos Clinical Project Portfolio Manager

After graduating in Pharmaceutical Biotechnology, he obtained a master’s degree in International Health Care Management, Economics and Policy at Bocconi University (Milan). He began his work experience in MediNeos in 2009 as Clinical Research Associate and later as a Study Designer. Since 2014 he has covered the role of Clinical Project Portfolio. Christian has a consolidated experience in: observational research, international and local project management and account, public speech and epidemiology

The webinar - that will be held at 3pm (CET) - is free and reserved to MediNeos clients

 


05 December 2019 (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 - that will be held at 3pm (CET) - 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