Discover the course

Medical Writing: from theory to practice

Deepening in the environment of scientific publications to write scientific articles achieving the desired objectives

Date

16 - 17 November 2020

Location

Milan

Language

Italian

Medical Writing: from theory to practice

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

Meta-analysis

The clinical study protocol

Literature search and retrieval

Clinical trial repositories

Preparation of a scientific publication (in groups)

Conclusion and final questions

Giovanni Goisis
Giovanni Goisis Principal Biostatistician - CROS NT

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 Rossi
Andrea Rossi Freelance International Scientific Communicator

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

• Scientists

• Regulatory

• Strategic Planning

of Pharmaceutical Companies, Medical Devices, Diagnostics, CRO, Biotech, freelancers.


The course is also aimed at:

• Hospital Research Centers

• Consultants

• University

• Public administrators



Participant experience

Participants should be aware of the basic principles governing clinical trials.

Interactive workshop with on-train exercises.

Hotel Melià
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.


Upon Arrival
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.

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.



Training Room

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.



Teaching materials

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.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.


Brochure
Certificate of attendance

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.

Register now

Course Price

1755.00 €

Early Bird

Monday, October 26, 2020

1535.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 days

Course Type

Limited number of participants

You will receive

Certificate of attendance

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

Participants' Feedbacks

Very focused and pragmatic

Environment was well described. I appreciated a lot the number of exercises

Practical and clear explanations

very effective training with exercises

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Medical Writing: from theory to practice

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link.