Discover the course
Medical Writing: from theory to practice
Deepening in the environment of scientific publications to write scientific articles achieving the desired objectives
The publication of study results is becoming increasingly difficult and requires specific skills. The scientific article is the preferred medium for the publication of these results. The environment of scientific communications is constantly evolving to answer to the growing demands of ethics, transparency, and quality from the patients.
The audience approaching to scientific articles is changing, too. The access to clinical trial databases, the growing use of open-access journals and the transparency rules have radically changed the approach to study design. The study communication strategy has become an integral part of any clinical trial planning.
The pharmaceutical industry has been moving in this direction for some time; the new EU regulations oblige medical devices and diagnostics producers moving in the same direction. Furthermore, anyone involved in the research, dissemination or use of scientific articles must become familiar with medical writing to achieve their goals.
These recent changes have radically shifted the environment of medical writing. The medical writer, traditionally working on regulatory documents, is no longer a ghostwriter but has become the strategic and engaging professional of health communications.
This course is based on a structure highly appreciated by hundreds of attenders in the last 10 years; this workshop is not only for medical writing professionals and authors but is a “must” for anyone involved in the planning of clinical studies.
During the workshop, the principles to be used to design a clinical study and to disseminate its results will be shared and applied in practical tests.
• Welcome and introduction
• Completing questionnaire 1 (individual)
• The fundamentals of clinical research and communication:
- the cycle of research
- the basics of communication
- scientific communication
- medical writing
• Statistics for planning, analyzing, presenting and interpreting clinical trial data.
• Analysis of the questionnaire (in groups)
• Presentation of the results (1 per group)
• The publication study outcomes
• Publications: definition, translations, language to be used
• Indexing and peer-reviewing
• Impact Factor
• Completing questionnaire 2 (individual)
• Interpretation and presentation of the results of a study
• Planning and allocation of resources
• Publication guidelines
• Internal and external validity
• The IMRAD structure of the scientific article
- the introduction
- materials and methods
- the results
- the discussion
- the conclusions
- the title
- the authors
- the abstract
• The other parts of the scientific article (acknowledgments, conflicts of interest, literature references)
• Analysis of questionnaires (in groups)
• Case reports
• Observational studies
• Uncontrolled studies
• Studies on diagnostics
• The levels of scientific evidence
• Systematic reviews: definition and classification
• The clinical study protocol
• Literature search and retrieval
• Clinical trial repositories
• Preparation of a scientific publication (in groups)
• Conclusion and final questions
Giovanni Goisis is a biostatistician with long experience at CRO, pharmaceutical / device industries and research institutions.
He currently works at CROS NT in the role of Principal Biostatistician.
Giovanni graduated in Biostatistics and Experimental Statistics at the University of Milan Bicocca in 2006 but since then he continues to have a passion for statistics and its applications in the clinical field.
Andrea has a degree in Biology from Florence University. After a brief spell at the University, he started working in the Italian Affiliate of Eli Lilly as a Clinical Research Associate. In the years that followed he was responsible for Statistics, Health Outcomes and Medical Information. Andrea has been working as Medical Writer since 2003 beginning in Italy and, then, becoming responsible of worldwide scientific affairs in a biosimilar company based in Switzerland.
He is author of more than 350 disclosures and acknowledged for his contribution in several others. From 2007 to 2009 he was on the coordination board of BIAS (Biometristi Italiani Associati) and has been a European Medical Writers Association (EMWA) member since 2004. Andrea acts as trainer for statistics and medical writing in some Italian schools for specialisation in medicine and has been a speaker at national and international conferences.
Andrea leads workshops for and is past-president and ambassador of EMWA.
The course is aimed at anyone who knows the fundamentals of clinical research and who is involved in the design and publication of its results, including:
• Medical Writers
• Medical Affairs
• Industry physicians
• Medical Liaisons
• Clinical Operations
• Scientific Communications
• Strategic Planning
of Pharmaceutical Companies, Medical Devices, Diagnostics, CRO, Biotech, freelancers.
The course is also aimed at:
• Hospital Research Centers
• Public administrators
Participants should be aware of the basic principles governing clinical trials.
Interactive workshop with on-train exercises.
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 1.535,00* (until 26 October 2020)
Ordinary: € 1.755,00*
Freelance - Academy - Public Administration: € 810,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Monday, October 26, 2020
At the end of the training, you will be able to
Manage the fundamentals of medical-scientific communication
Provide knowledge on the basics of medical writing
Define when, how and where to disclose the results of a clinical study successfully
Write a simple publication using the results of a clinical study