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Management Forum

Successful Medical Writing – from Protocol to CTD Training Course

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive, practical medical writing course will benefit participants by enabling them to achieve this standard.

★★★★★ "Overall very very pleased with the course and it has thoroughly extended my interest and drive to be... more (47)"

16-17 January 2025
+ 5-6 June 2025, 25-26 September 2025 »
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

Download Print Enrol or reserve

Course overview

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring a positive outcome. This intensive three-day medical writing course will help you to improve your skills and achieve this standard.

This course is part of our Medical Writing Training Courses series that aims to equip delegates with the tools and techniques needed to thrive within an ever-evolving industry.

Benefits of attending

Gain in-depth knowledge on general writing and data presentation skills, specifically in the kind of documents most frequently encountered in clinical research
Understand the international guidelines and standards
Explore both the theoretical and practical aspects of writing for regulatory authorities through illustrative examples

Who should attend?

The course will be of interest to all those in the pharmaceutical industry who prepare research reports and documentation intended for regulatory authorities. Although the focus of the seminar is on clinical research, many of the principles will also apply to other types of reports, including pre-clinical, CMC and veterinary documentation. The practical training will benefit not only those new to medical writing but also those wishing to perfect their existing writing skills, including full-time medical writers and those who only occasionally write research documentation or regulatory submissions.

Enrol or reserve

This course will cover:

Day 1
Day 2

Day 1 – Fundamentals of Regulatory Medical Writing

Introduction to regulatory medical writing

Overview of medical writing in the pharmaceutical industry
Types of documents
Project management
Working cross-functionally
Document reviews
Quality checks

Regulatory environment and guidelines

Regulatory agencies and key regulatory guidelines
Drug development lifecycle and regulatory milestones

Regulatory documents

What are they and why are they needed?
Developing the protocol and ICFs
Developing the CSR
Developing the Investigator’s Brochure
Developing the DSUR

Day 2 – Scientific Advice and Marketing Applications

Briefing documents

What are they?
Why are they needed?
How are they developed?

Importance of real-world evidence and patient-centred outcomes

The Common Technical Document

Introduction to clinical submission dossiers
Writing the clinical overview & the clinical summary

Enrol or reserve

Cheryl Roberts-Vitalis
BioMarin Pharmaceutical Inc.

Cheryl is currently the Global Head of Medical Writing at BioMarin Pharmaceutical Inc., and specialises in medical writing for serious and life‑threatening rare diseases. She joined the pharmaceutical industry in 2001 in drug development, and continued in positions in medical editing and medical writing in both the pharmaceutical and consultancy industry. She holds a degree in Medical Biology and a Masters in Neuroscience. Cheryl has been an approved workshop leader for the European Medical Writers Association since 2015 and gives training on subgroup analyses and orphan medicinal products.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

16-17 January 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 14608

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 12 Dec

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

5-6 June 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14872

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 01 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

25-26 September 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15102

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 21 Aug

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Successful Medical Writing – from Protocol to CTD training course

Overall very very pleased with the course and it has thoroughly extended my interest and drive to become a full medical writer

Apr 27 2022

Louise Bussey United Kingdom
Senior Clinical Study Manager, Vaccitech (UK) Limited

Apr 27 2022

The content for each day was great and very informative, as a new starter to the industry it really helped me to gain an understanding of the layout, structure and what to look out for in study reports and submission documents etc. The presentations were clear and concise, and it is clear that each speaker is very passionate about their role, which is shown through their strong knowledge and experience. [...] each speaker came across very well and their understanding of medical writing, along with their expertise really helped me to understand each aspect of their presentations thoroughly.

Ruby Morrissey United Kingdom
Regulatory Writer, Imperial Brands

Jul 11 2022

The content was targeted, appropriate and informative. Presentations were good, incorporating both text and visual elements to keep us engaged, and the speakers were friendly and involved. I am new to medical writing. I hoped to gain knowledge regarding the different documents I may be working on, how to coordinate different contributors, and how to involve statistics and data presentation in my writing. This course substantially helped to clarify these things.

Holly Smith Australia
Medical Writer (Graduate Program), WriteSource Medical

Jul 11 2022

Overall, I found the webinar interesting and worthwhile. The speakers were all highly knowledgable and gave good advice. I believe this webinar is suitable for beginner medical writers.

Dulama Richani Australia
Medical Writer, WriteSource Medical Pty Ltd

Apr 27 2022

I enjoyed it, found it useful and it was clearly led by experts - I would recommend

Ian Walker United Kingdom
Programme Lead, Triducive

May 24 2021

I got what I hoped for - i.e. an introduction to the types of documents I will come across, how to select the right content, and how to write it. On top of this, it was extremely useful for me to receive all the little tips and tricks. I think all presenters were very generous in sharing their experience. This includes how to manage difficult stakeholders, when to stick to guidelines and when to use common sense, where to find links on correct use of English, and even be able to ask questions in the future on how to present data.

Lone Helboe Denmark

May 24 2021

I was really satisfied with the webinar. It reflected my expectations and it addressed my needs.

Roberta Grimaldi United Kingdom
Clinical research principal scientist, GSK

May 24 2021

Good, engaging and knowledgeable speakers.

Marit Sorum Norway
Regulatory Affairs Manager, Pharmaq

May 24 2021

I wanted to get some hints and tips on general improvements in writing style when compiling regulatory dossiers - and interested to know more about the required content in the clinical section of the eCTD, which I believe was delivered.

Judith Rowland United Kingdom
Senior Regulatory Affairs Manager, Nerudia Limited

Oct 5 2020

What a wonderful training course, especially for medical writers beginning their career. So much information is packed in this webinar and is presented in a very professional and entertaining way. Warmly recommended.

Cristiane Jensen Denmark
Senior Electronic Submissions Coordinator, H. Lundbeck A/S

Oct 5 2020

Overall, very interesting and enjoyable.

Tyrnnon Steffen Belgium
Medical Writer, DICE-CRO

Oct 5 2020

A fantastic training, a "must-do". The training via live webinar is working very well, less resource-demanding (time and costs).

Tifany Desprez France
Medical Writer, PhD, Laboratoires THEA

Oct 5 2020

This webinar had a broad array of topics and was delivered in a very interesting manner. The courses were nicely illustrated by a large number of examples and exercises. The speakers managed to deliver their messages efficiently, involving and keeping the interest of the audience along the 3 days.

Ophelie Poujade Switzerland
Regulatory Affairs Specialist, Alexion Pharma GmbH

Oct 5 2020

The interactive exercises and polls were very useful, in the future you could include more of these.

Julia Peics Denmark
Medical Writer, ALK

Oct 14 2019

The content of the talks was appropriate and useful, the topics were clearly presented and the practical exercises helped to learn efficiently.

Katrin Vögtlin Germany
Manager Clinical Affairs, Richard Wolf GmbH

Oct 14 2019

Each speaker was very inspiring.

Natasa Fischbach Simunic Croatia
Medical /Pharmacovigilance Advisor, Xellia d.o.o.

Oct 14 2019

The content is highly relevant for new medical writers and the speakers are engaging. I would recommend it for anyone entering the profession.

Maria Dzialo United Kingdom
Medical Writer, Data Investigation Company Europe

Oct 14 2019

I love this course and have recommended it to my colleagues.

Nisha Patel United Kingdom
Clinical Research Principal Scientist, GlaxoSmith Kline

Oct 14 2019

Absolutely perfect. I was personally looking for a change in my career and medical writing is definitely my first choice. The presentations were very interactive and fun!

Bouchta Karrich France
Scientific Information Officer, Laboratoires THEA

May 21 2019

The intensive course gave a comprehensive overview on the topic of medical writing. Each of the lecturers were interesting, dynamic and very professional, with a good sense for humour also. You can gain a new perspective on the differences of various European languages and on the way the English language has developed throughout the years, and can also pick up various tips and tricks to become a successful medical writer.

Maja Culjak Croatia
Associate for Medicinal Product Information Review, Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

May 21 2019

It surpassed my expectations in every way.

Vasco Cluny Portugal
Freelancer Science/Medical Writer, Built by Doctors

May 21 2019

The course was very informative and provided ample guidance on how to approach writing various documents. I found the examples and exercises very useful. The presenters were very engaging. The course met all my expectations.

Anuradha Marla Denmark
Medical Writer, LEO Pharma A/S

May 21 2019

I was very happy with the course. For me, with 2 years of experience interpreting clinical data but no MW experience, it was the exact level I needed. I got a lot of new information but I felt like I could still follow everything.

Thea Christensen Denmark
Medical Writer , ALK-Abelló

May 21 2019

I really liked the course overall. The content was new and exciting and the speakers and presentations high quality.

Stine Spray Denmark
Specialist, Medical Communication, Regulatory Affairs, William Cook Europe

May 21 2019

Really great course with very useful content and excellent speakers.

Janne Walmod Denmark
Medical Communication Specialist, Cook Medical

May 21 2019

I have enjoyed this course very much. It was a nice atmosphere and the content was good overall. The presentations were helpful and the speakers had a good knowledge of the topics.

Marga Paterson Netherlands
Senior Medical Writer, Vennlife Sciences EDS

May 15 2018

I attended previously EMWA workshops where the speakers had presented - so I knew previously that they are good! The course was vey good, interesting topics and good interaction between attendees and presenters.

Helen Thorne Switzerland
Medical Writer , Tillotts Pharma AG

Oct 15 2018

The training was of good quality and the speakers succeeded in making it dynamic and practical. It will be very helpful for my future work.

Adeline Pierre Germany
Medical Manager, Bayer Consumer Care

Oct 15 2018

Great course, I learned a lot.

Danielle Rieks Netherlands
Regulatory Affairs Officer, Beaphar B.V.

May 15 2018

The course met all of my expectations

Fida Issa Denmark
Safety Surveillance Specialist, Novo Nordisk A/S

May 15 2018

Really well organised sessions, good break up of topics. Excellent course!

Emma Biggs United Kingdom
Clinical Research Scientist, GlaxoSmithKline

Oct 15 2018

Speakers were highly engaging. Content and presentation were straight to the point with useful examples/exercises. This course was very helpful.

Elsa Sirou Switzerland
Regulatory Affairs Specialist, Alexion Pharma GmbH

May 15 2018

Very good, knowledgable, clear, supportive of medical writers and the battle they have with clients.

Ruth Forster United Kingdom
Post Marketing Project Manager/Medical Writer, ProductLife

Oct 18 2017

A really excellent course that has given me a lot more confidence in my job

Karin Jackson Sweden
Regulatory Coordinator, Hansa Medical AB

Oct 18 2017

Professional, interesting and relevant

Birgitte Sonne Rasmussen Denmark
GCP-Coordinator, GCP-Unit, Denmark

Oct 18 2017

The workshops were very comprehensive and I'm glad there was time for group exercises, which added great value to our discussions/learning

Joana Fernandes United Kingdom
Medical Writer, Scinopsis Ltd

Oct 18 2017

Great speakers with a very deep knowledge on the subject

Jone Iriondo France
Medical Writer, Insitut Bergonié

May 10 2017

Very good quality content and presentations. I am pleased and satisfied by this course

Louise Harkness United Kingdom
Medical Writing Scientist, GlaxoSmithKline

May 10 2017

An informative course with entertaining sessions

Anna LeMoine United Kingdom
Project Leader, Tissue Regenix Ltd

May 10 2017

Adequate content. Interesting presentation. Dynamic, clear, competent and experienced speakers.

Agathe Caruso-Vares France
CEVA Sante Animale

May 10 2017

The course provided a good overview of the medical writing, I liked the way that the information was split among the three days and the speakers were really good

Soteroulla Ioannou Netherlands
Medical Information Specialist, Janssen Biologics B.V.

May 10 2017

Content is good for newbies like me but it seems that other participants that are working in the area benefited. The presentations are easy to follow and right on point. Barbara, James, and Barry are inspiring.

Bettina Overgaard Switzerland
Bettina Overgaard

Oct 18 2017

All great speakers, very knowledgable

Mike Mueller United Kingdom
Medical Writer, Scinopsis Ltd

Oct 18 2017

Inspiring yet realistic

Ghazaleh Karimi Sweden
Drug Safety Manager, AbbVie

Oct 19 2016

Very useful on a daily basis, long lasting learning, lively speakers and presentations

Solange Van de Moortele France
Clinical Project Manager, Wright

Oct 19 2016

Was excellent, interactive, and the exercises were very useful to apply what was learnt in the course