Presented by
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)
★★★★★ "Overall, I felt the course content was excellent; it contained a lot of relevant and useful informat... more"
5-6 Oct 2022
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
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.
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
The Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application course will cover:
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
John Price
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).
Book Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Live online training
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*
5-6 Oct 2022
Live online
12:30-16:15 UK (London) (UTC+01)
13:30-17:15 Paris (UTC+02)
07:30-11:15 New York (UTC-04)
Course code 11852
- GBP 499 599
- EUR 719 859
- USD 814 970
Until 31 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
* 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.
Reviews of IPI's Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application training course
I did get some interesting information that may be useful when writing these documents in the future.
Mar 16 2022
Nele Hilgert 
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 
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
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 
Medical Writer, Pharmaceutical Company
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
Medical Writer, Pharmaceutical Company
Mar 19 2019
Very accomplished. A lot of useful info
Camilla Hammerum
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 
R&D Project Manager, Disphar International B.V.
Mar 19 2019
Clear, manage of the knowledge, practice, orientated.
Diego Silva Vasquez
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
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
Medical Writer, Scinopsis Ltd
Mar 13 2018
Excellent overview - very comprehensive and clearly presented
Sue Tollerfield
Senior Medical Writer, Scinopsis
Mar 13 2018
I was really content about the course. I found the information to be very complete
Samuel Vandenbussche
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
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
Medac GmbH
United Kingdom
- AbbVie Ltd
- AstraZeneca
- Cycle Pharmaceuticals Ltd
- GW Pharmaceuticals Ltd
- Hameln Pharmaceuticals Ltd
- Ipsen
- Ipsen Biopharm Ltd
- JensonR+ Limited
- Martindale Pharm
- Martindale Pharma
- McDonough Clinical Research Ltd
- NDA Group
- NDA Regulatory Science Ltd
- Norgine
- Omega Pharma Ltd
- Orchard Therapeutics
- Pfizer Limited
- Pharmaceutical Company
- Reckitt Benckiser
- Scinopsis
- Scinopsis Ltd
- Teva UK Ltd.
- The Lewis David Consultancy Ltd
- United Therapeutics Europe Ltd
France
- GALDERMA Recherche & Developpement
- Innate Pharma
- LFB Biotechnologies
- Merck Sante s.a.s.
- Sanofi Aventis Recherche et Développement
- SERB SAS
Netherlands
- Astellas Pharma Europe BV.
- BBio
- Disphar International B.V
- Disphar International B.V.
- Eurodrug Laboratories B.V.
Belgium
- Emtex Life Science
- PhaRA BVBA
- Tigenix NV
- UCB Pharma SA
Germany
- Bavarian Nordic
- Daiichi Sankyo Europe GmbH
- Medac GmbH
- Trilogy Writing & Consulting GmbH
Switzerland
- Galapagos
- Novartis
- Novartis Consumer Health SA
Finland
- Medfiles Ltd.
- Orion Corporation
Italy
- Angelini ACRAF s.p.a.
- Zambon S.p.A.
Croatia
- Belupo d.d.
Latvia
- Olainfarm AS
Spain
- Dr. Victoria Howe
Run Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Live online for your team
1 day
Typical duration
Pricing from:
- GBP 450
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
