Medical Communications & Regulatory Writing

Introduzione

Each 3-step medical writing path will cover different aspects of medical communications and regulatory writing in line with the needs and requirements of those willing to step into the field or willing to improve their writing skills.

Two different paths designed to give you the tools you need to improve your skills and the quality of your scientific texts.

Medical Communications Path
You will learn to find your way around the substantive and technical aspects of medical writing and editing. You will understand how to appropriately approach the challenges of publication planning. You will be helped to start writing scientific articles for peer-reviewed journals in the right way, effectively communicate your findings and conclusions and optimise the writing process.

Regulatory Writing Path
You will be put on the right path to become a skilled and successful writer with an introduction to the characteristics of good quality of technical and scientific documents. You will address the stages of preparation of a Clinical Study Protocol. You will understand how to schedule, manage and author a Clinical Study Report.

An opportunity to learn the insights of the Medical Writing world through case studies, discussions and examples.

Medical Writing Path 1 | Medical Communications

Knowing the basics of writing scientific texts

1.”Medical Writing Course: Improve your Writing & Reviewing Skills”

Training Duration: 3 modules of 2 hours each (6 hours in total)
Dates: 15th, 17th and 19th March 2021; 10:30 am – 12:30 pm CET

The aim of this course is to improve medical writing skills & the quality of texts that you regularly prepare or review. Whether your text is an email, laboratory report, summary, regulatory submission, manuscript or business proposal, learn to make your message effective.

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Appropriately approach the strategic Publication Planning

2.”7-Step Workshop to Master your Publication Planning”

Training Duration: 2 modules of 3.5 hours each (7 hours in total)
Dates: 08th and 09th April 2021; 9:30 am – 1:00 pm CEST

In this workshop the key aspects and challenges of Publication Planning will be explored to give insights on what publication planning is, the importance of good publication planning and how the different figures involved in the development of disclosures can work together to succeed.
Maximize the impact of:
▪ Scientific manuscripts in peer-reviewed journals
▪ Data presented at congresses
▪ Data published on clinical trial registries
▪ Data included in Clinical Study Reports
▪ Data shared through social media

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The basics for writing a scientific paper

3.”Writing Scientific Articles: Starting with the Right Foot”

Training Duration: 4 modules of 2 hours each (8 hours in total)
Dates: 10th, 11th, 12th and 17th May 2021; 2:00 pm – 4:00 pm CEST

This workshop will help you start writing scientific articles for peer-reviewed journals in the right way, effectively communicate your findings and conclusions and optimise the writing process.
Attendees will benefit from the perspective and experience of two international experts in writing scientific papers and their management. Between them, they have successfully published many hundreds of articles across a wide variety of scientific and clinical specialties.

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Medical Writing Path 2 | Regulatory Writing

What are the characteristics of good quality technical/scientific documents?

1.”Tips and Tricks to Improve your Technical/Scientific Writing”

Training Duration: 3 modules of 2 hours each (6 hours in total)
Dates: 27th, 28th and 29th September 2021; 2:30 pm – 4:30 pm CEST

How can we prepare documents that please our audience? Are there general rules that might help us effectively write any type of technical/scientific documents?
This course will answer those questions and more, putting you on the right path to become a skilled and successful writer. Through exercises and discussion, you will learn fundamental techniques that will allow you to prepare high quality documents.

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The importance of the protocol as the central document for a study

2.”Clinical Study Protocols – Structure & Content”

Training Duration: 3 modules of 3.5 hours each (10.5 hours in total)
Dates: 06th, 07th and 08th October 2021; 9:30 am – 1:00 pm CEST

The study protocol is the foundation of any clinical research and a key factor in the success of its conduction. This course will give you an insight into the importance of study protocols as core documents of any clinical study. We will discuss the essential elements, the structure and its content with a hands-on practical approach.

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The final step…preparing a good quality Clinical Study Report!

3.”Clinical Study Reports – a 360° Perspective”

Training Duration: 2 modules of 3 hours each (6 hours in total)
Dates: 27th and 28th October 2021; 9:30 am – 12:30 pm CEST

This virtual course in 2 sessions covers scheduling, managing and authoring of clinical study reports (CSRs) for modern design clinical studies. It discusses the stages of preparation of CSRs in the context of precursor documents including the clinical study protocol (CSP), the statistical analysis plan (SAP), and the incorporation of study data. Components of the integrated CSR include narratives and appendices, and the preparation of these sections of the CSR will also be covered. Scheduling an achievable reporting timeline for this complex and multi-component document will be explained.

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Clinical Affairs staff
Regulatory affairs professionals
Clinical Operations staff
Medical Writer
Professionals moving into medical writing

Upon completion of one of the two Medical Writing Paths all delegates will be awarded a certificate of attendance for continuing professional development purposes.

Interactive workshop with exercises and application to participant’s daily activities.

Docente/i

Info

Barbara Grossman

Hawkeye Medical Limited

Barbara Grossman has a passion for proofreading, quality control, and education. She started Hawkeye Medical Limited, a medical writing and consultancy business, after working for a medical publishing company and then a contract research organisation, where she built up and managed its medical writing group. Barbara runs professional development training for companies and educational institutions. She has had many roles in the European Medical Writers Association (EMWA): workshop leader since 2001, Treasurer 1998–2005, member of the Education Committee 2010–2018, Education Officer 2014–2016. She was awarded an EMWA fellowship in 2005 and was EMWA President for 1 year until May 2020. In addition, Barbara is an Associate Editor of Medical Writing, EMWA’s journal.

Info

Andrea Rossi

Consultant in Medical Writing, Communications and Scientific Affairs

Andrea has more than 30 years of experience in clinical research and physician relations. Author of more than 400 publications and articles, including more than 70 in peer-reviewed journals. He is past president, workshop leader, chairman of the study group on scientific communication and artificial intelligence, chair of the Italian group, and ambassador for the European Medical Writers Association (EMWA), of which he was president. In addition to his professional activities and training in medical schools, research centers, and medical-scientific societies, he acts as a speaker and chairman at several conferences.

Info

Phillip Leventhal

Manager of Medical Writing and Healthcare Communications at Evidera-PPD

Phillip Leventhal, PhD is a Manager of Medical Writing and Healthcare Communications at Evidera-PPD, where he specialises in scientific writing. He has nearly 20 years’ experience as a medical writer, has written and edited hundreds of peer-reviewed articles, and has worked extensively with, and trained, non-native English speakers in scientific writing. From 2012–2020, Phil was the Editor-in-Chief of the journal Medical Writing, and since 2010, has led professional workshops and academic courses on scientific writing throughout Europe and North America.

Info

Monica Milani

Freelance Medical and Scientific Writer

Monica Milani has been a medical writer since 2011. She began her career in a medical writing company, and then moved to the pharmaceutical industry. She has experience in a wide range of regulatory and medical communication documents covering various therapeutic areas. Prior to medical writing, she worked in academia and authored numerous articles in the immunology and oncology fields. She was editor‑in‑chief of the open access journal Drug Target Insights from 2008 to 2011 and served as a reviewer for several peer-reviewed journals. She is also an active member of the European Medical Writers Association (EMWA). Monica holds degrees in biological sciences, biotechnology and scientific/technical communication.

Info

Sam Hamilton

Regulatory Medical Writing Strategist and Educator

Sam Hamilton is a postdoctoral virologist with 29 years in clinical and regulatory medical writing roles, including leadership positions, in the pharmaceutical industry. Sam is an expert in writing and managing clinical-regulatory documentation for medicines licensing, and am international speaker in the area of public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the May 2016 open-access www.core-reference.org. Sam is long-time supporter of her professional association, the European Medical Writers Association (EMWA) www.emwa.org serving in various roles over 17 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW) (journal); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President of the Executive Committee (EC). Sam was elected an EMWA Fellow in 2018 for her services to EMWA and the global MW community. Currently, Sam is MEW Section Editor for the “Regulatory Public Disclosure” Section, a Workshop Leader, and serves on the Advisory Panel of the EMWA Regulatory Public Disclosure Special Interest Group.

Durata e Informazioni utili
Quote Iscrizione

Medical Writing Path 1 | Medical Communications:

Medical Writing Course: Improve your Writing & Reviewing Skills
15, 17 and 19 March 2021 | 10:30 am – 12:30 pm CET

7-Step Workshop to Master your Publication Planning
08 and 09 April 2021 | 9:30 am – 1:00 pm CEST

Writing Scientific Articles: Starting with the Right Foot
10, 11, 12 and 17 May 2021 | 2:00 pm – 4:00 pm CEST

Medical Writing Path 2 | Regulatory Writing:

Tips and Tricks to Improve your Technical/Scientific Writing
27, 28 and 29 September 2021 | 2:30 pm – 4:30 pm CEST

Clinical Study Protocols – Structure & Content
06, 07 and 08 October 2021 | 9:30 am – 1:00 pm CEST

Clinical Study Reports – a 360° Perspective
27 and 28 October 2021 | 9:30 am – 12:30 pm CEST

Some days before the online training you will receive all details about the connection.

Each online training 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.

Number participants: 12 maximum each online training.

Sign up for Medical Writing Path 1 and 2 at:
Early Bird: € 3.560,00* (until 01 March 2021)
Ordinary: € 4.480,00*
Freelance – Academy – Public Administration**: € 2.315,00*

Sign up for Medical Writing Path 1 | Medical Communications at:
Early Bird: € 1.875,00* (until 01 March 2021)
Ordinary: € 2.350,00*
Freelance – Academy – Public Administration**: € 1.220,00*

Sign up for Medical Writing Path 2 | Regulatory Writing at:
Early Bird: € 1.908,00* (until 30 August 2021)
Ordinary: € 2.400,00*
Freelance – Academy – Public Administration**: € 1.240,00*

* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials for each training and attendance certificate that will be sent after the complete Medical Writing Paths via e-mail.

If you prefer to enroll in single courses, a discount of 10% applies when enrolling to 2 courses of the Path.

If you sign up for one of the below additional medical writing courses, you benefit from 5% discount

Do-It-Yourself or Outsource? Cooperation with Medical Writing Providers
How to get the most out of your medical writing consultant
Great Topic – Shame About the Slides!
Creating clear and professional-looking slide decks to communicate biomedical science
Searching the Medical Literature
How and where to find the biomedical data you need
Beyond PubMed
Additional approaches and sources for cost-effective literature monitoring
Writing Science for Lay Audiences
Ways to improve the readability of your message
Medical Reading
The critical evaluation of scientific publications

Visit each course online brochure for more information! www.lsacademy.com

Versione Stampabile

Cosa saprai fare dopo il percorso formativo

AFTER THE END OF THE MEDICAL WRITING PATH 1 | MEDICAL COMMUNICATIONS:

- You will better address the substantive and technical aspects of medical writing and editing

- You will understand how to appropriately approach publication planning

- You will be able to properly write scientific articles for peer-reviewed journals

AFTER THE END OF THE MEDICAL WRITING PATH 2 | REGULATORY WRITING:

- You will know what the characteristics of good quality technical and scientific documents are

- You will know how to address the stages of preparation of a Clinical Study Protocol

- You will understand how to schedule, manage and author a Clinical Study Report

Online interactive training on Zoom platform.

LS Academy will provide the access link to the virtual platform a few days before the training.

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Medical Writing Paths: ‘Medical Communications’ & ‘Regulatory Writing’

Medical Writing Paths: 'Medical Communications' & 'Regulatory Writing'

Introduzione

Medical Writing Path 1 | Medical Communications

Medical Writing Path 2 | Regulatory Writing

Docente/i

Barbara Grossman

Andrea Rossi

Phillip Leventhal

Monica Milani

Sam Hamilton

Cosa saprai fare dopo il percorso formativo