Presented by
Management Forum
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)
30 Mar 2022 + 1 more date
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:
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).
30 Mar 2022
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 11590
Until 23 Feb
8 Sep 2022
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 11852
Until 04 Aug
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.
Mar 30 2021
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
UK
France
Netherlands
Germany
Belgium
Switzerland
Italy
Croatia
Finland
Latvia
Spain
Multiple colleagues?
Talk to one of our training experts to discuss how to:
Cookies: we use cookies to deliver the best experience to you and to help us understand our customers.
