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Management Forum

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD).

★★★★★ "John Price explained all information in practical and useful way. I have been satisfied from the who... more (21)"

23-24 October 2024
+ 5-6 February 2025, 18-19 June 2025, 1-2 October 2025 »
from £549

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Format: Live online
CPD: 6 hours for your records
Certificate of completion

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Course overview

The Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications. The clinical overview and clinical summaries in Module 2 provide a critical analysis of the clinical data within the CTD.

This interactive course will present the regulatory guidelines and requirements of Module 2 and discuss practical approaches to developing the content and preparation of the clinical overview and clinical summaries. The programme will provide a review of the latest information and potential future developments and cover associated documents, such as the RMP and SmPC. A practical workshop session will simulate real situations and highlight the key issues to consider when preparing the content of the written summary.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

Gain practical advice on writing clinical documents for global submissions
Review the latest guidance to ensure you meet regulatory expectations
Understand how to prepare separate integrated summaries of efficacy and safety for FDA
Clarify the content of orphan drug applications, over-the-counter (OTC) switches, line extensions and safety-related labelling updates
Ensure your risk management plan (RMP) is consistent with the Common Technical Document (CTD)
Discuss the place of the clinical overview and summary in life cycle knowledge from initial IB to PSUR, and how they support the changing summary of product characteristics (SmPC)

Who should attend?

Senior R&D managers
Members of medical science clinical trial departments
Medical writers
Regulatory affairs personnel
All those interested in the CTD document, clinical overview and summary and its place in the evolving clinical, safety and regulatory processes

Enrol or reserve

This course will cover:

Day 1
Day 2

The CTD Guideline

CTD modules, structure and content
An effective clinical overview
The role of the written summary
Agency validation

Planning content of the clinical overview

Data sources
Presenting efficacy and safety data
Risk management
Expressing benefit/risk
Comparative effectiveness
Avoiding pitfalls

Content of the written summary – practical considerations including a workshop

The document writing process
- Templates
- Style
- Timelines
- Efficiency
The writing team
Engaging and working with external writers
Getting started, and reviewing and interpreting data
Document review: avoiding rework
Achieving quality
Document review and approval

Meeting regulators’ expectations

The CTD in a global company: regional and country requirements
Is a separate ISS or ISE necessary for an application to FDA?
Writing for NCEs, orphan drugs, over-the-counter switches, MA renewal, generic products and line extensions
Recent developments and their effect on producing future CTDs
- The RMP and risk evaluation and mitigation strategy (REMS)
Writing an overview and summary to support the SmPC and labelling changes

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John Price
John Price Pharma Solutions

Dr John Price is a physician consultant in pharmacovigilance and regulatory affairs, working with several small biotechnology companies in North East USA planning submissions for marketing approval of oncology, haematology, renal and orphan drugs.
He was previously Vice President and Head of Global Pharmacovigilance and Drug Safety at Alexion Pharmaceuticals, USA. Until 2014 he was VP and Head of Medical, Clinical and Regulatory Operations at Johnson and Johnson Consumer Health, USA and previously VP of Medical Documentation, Labelling and Submissions Management, Worldwide Safety and Regulatory Operations, Pfizer Inc, USA. In these roles he has led and participated in the preparation of multiple clinical overviews and summaries for MAAs, variations, renewals and labelling updates globally.
He is a physician trained also in clinical pharmacology who has worked in the pharmaceutical industry since 1998, including working as a consultant providing medical writing support to pharmaceutical companies and service providers. Prior to joining Pfizer he spent 7 years as medical assessor and head of the Clinical Evaluation Unit of the Post Licensing Division at the Medicines Control Agency (now the Medicines and Healthcare products Regulatory Agency).

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

23-24 October 2024

Live online

13:30-17:15 UK (London) (UTC+01)
14:30-18:15 Paris (UTC+02)
08:30-12:15 New York (UTC-04)
Course code 13964

GBP 549 649
EUR 789 929
USD 893 1,049

Until 18 Sep

2 sessions of 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 February 2025

Live online

13:30-17:15 UK (London) (UTC+00)
14:30-18:15 Paris (UTC+01)
08:30-12:15 New York (UTC-05)
Course code 14491

GBP 549 649
EUR 789 929
USD 893 1,049

Until 01 Jan

2 sessions of 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

18-19 June 2025

Live online

13:30-17:15 UK (London) (UTC+01)
14:30-18:15 Paris (UTC+02)
08:30-12:15 New York (UTC-04)
Course code 14759

GBP 549 649
EUR 789 929
USD 893 1,049

Until 14 May

2 sessions of 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

1-2 October 2025

Live online

13:30-17:15 UK (London) (UTC+01)
14:30-18:15 Paris (UTC+02)
08:30-12:15 New York (UTC-04)
Course code 14961

GBP 549 649
EUR 789 929
USD 893 1,049

Until 27 Aug

2 sessions of 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 Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application training course

John Price explained all information in practical and useful way. I have been satisfied from the whole shapes of the program. For sure I will recommend it to other colleagues.

Feb 7 2024

Marco Taras Italy
Regulatory Affairs, Philogen S.p.A.

Jun 28 2023

Very well organized and detail to address areas I would not have considered - very grateful they were addressed! I received more value that I anticipated and would absolutely recommend to anyone who writes Module 2.5 and 2.7

Angela Turner United States of America
RA Director,

Feb 8 2023

Overall the course is interesting and detailed and provides good overview of process and requirements for clinical module 2 sections. John is very knowledgeable and shares his knowledge in a clear manner with audience and answered all our questions during the course.

Michalina Najda United Kingdom
Regulatory Affairs Manager, Theramex

Oct 4 2023

I wanted to broaden my knowledge of submissions, I think it's accomplished

Caroline Baudino France
Medical Writer Project Lead, Ipsen Innovation S.A.S, Accounting Department

Oct 5 2022

Very interesting content, excellent presentation, helpful for future work

Heidrun Mylius Germany
Senior Medical Writer & Process Improvement Manager, Medac GmbH

Oct 5 2022

Great presentation. Excellent delivery. Perfect amount of information for the level at which I am currently at.

Anna Johnstone United Kingdom
Senior Regulatory Officer, JensonR+ Limited

Oct 5 2022

It was a very good webinar. I have learnt more about clinical summaries and overviews. This webinar will definitely help me as a medical writer.

Andreia Mónico Portugal
PhD, Owlpharma

Mar 16 2022

I did get some interesting information that may be useful when writing these documents in the future.

Nele Hilgert Belgium
Medical Writer, Emtex Life Science

Mar 30 2021

It was a very nice webinar and met my expectations. The slides were well structured and the content nicely presented. It was great to profit from John´s huge experience.

Katharina Broeker Germany
Scientific Expert, Department of Medical Affairs, Medac GmbH

Mar 30 2021

It was a very interesting and useful webinar. I would definitely recommend it.

Fernando Bergantinos Germany
Manager. Drug Safety Scientist, Daiichi Sankyo Europe GmbH

Mar 19 2019

Overall, I felt the course content was excellent; it contained a lot of relevant and useful information that was well-organised. The course was presented at a pace that kept the audience's attention and involved them throughout. The speaker was very experienced in the topic, open to answering questions in a calm and professional way, being sure to clarify that he understood what was being asked.

Lynne Isaac United Kingdom
Medical Writer, Pharmaceutical Company

Mar 19 2019

Lynne Isaac United Kingdom
Medical Writer, Pharmaceutical Company

Mar 19 2019

Very accomplished. A lot of useful info

Camilla Hammerum United Kingdom
VP, Ipsen

Mar 19 2019

The course was informative and all topics on the agenda were addressed. There were also plenty of opportunities to ask questions and have discussions due to the small group size.

Rasielle Gonzales Netherlands
R&D Project Manager, Disphar International B.V.

Mar 19 2019

Clear, manage of the knowledge, practice, orientated.

Diego Silva Vasquez Netherlands
Regulatory Affairs Coordinator, Eurodrug Laboratories B.V.

Mar 19 2019

Presentation was clearly structured and there was a good interaction with the speaker.

Sofie Stalmans Belgium
Regulatory Affairs, PhaRA BVBA

Mar 13 2018

There was a good level of detail for each section of the clinical overview/summaries. The presentation was well thought out and the take home book an added benefit. The speaker's knowledge of the inside workings of the health authorities was invaluable.

Dominique Helberg United Kingdom
Medical Writer, Scinopsis Ltd

Mar 13 2018

Excellent overview - very comprehensive and clearly presented

Sue Tollerfield United Kingdom
Senior Medical Writer, Scinopsis

Mar 13 2018

I was really content about the course. I found the information to be very complete

Samuel Vandenbussche Belgium
Regulatory Affairs Consultant, PhaRA BVBA

Mar 27 2017

The course was really specific and delivered the contents expressed in the summary. It was very organized and well structured. The speaker was very knowledgeable and answered every question I asked. I was overall very satisfied with the whole course.

Andres Uribe Marino Germany
Medical Writer, Bavarian Nordic

Mar 27 2017

The structure of the content was very clear. The presentation was good. The speaker was well prepared and could answer all questions.

Claudia Hemmelmann Germany
Medac GmbH

United Kingdom