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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)

30 Mar 2022

& 8 Sep 2022

Book now

Details

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

Programme

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

Presenter

John Price (More...)

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 now

Book now

30 Mar 2022
Live webinar
30 Mar 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 23 Feb 22*
Enrol now
to attend
Live webinar
8 Sep 2022
Live webinar
8 Sep 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 4 Aug 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • AbbVie Ltd
  • Astellas Pharma Europe BV.
  • Bavarian Nordic
  • BBio
  • Cycle Pharmaceuticals Ltd
  • Disphar International B.V.
  • Galapagos
  • GW Pharmaceuticals
  • LFB Biotechnologies
  • Martindale Pharma
  • McDonough Clinical Research Ltd
  • Medac GmbH
  • Merck Sante s.a.s.
  • NDA Regulatory Science Ltd.
  • Norgine
  • Novartis
  • Olainfarm AS
  • Omega Pharma Ltd
  • Orchard Therapeutics
  • Pfizer Limited
  • PhaRA BVBA
  • Pharmaceutical Company
  • Scinopsis Ltd
  • TEVA UK LTD
  • The Lewis David Consultancy Ltd
  • Tigenix NV
  • Trilogy Writing & Consulting GmbH
  • UCB Pharma SA
  • United Therapeutics Europe Ltd
  • Zambon S.p.A.

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

Fernando Bergantinos, Manager. Drug Safety Scientist, Daiichi Sankyo Europe GmbH, Mar 21

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 21

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

Sofie Stalmans, Regulatory Affairs, PhaRA BVBA, Mar 19

Clear, manage of the knowledge, practice, orientated.

Diego Silva Vasquez, Regulatory Affairs Coordinator, Eurodrug Laboratories B.V., Mar 19

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

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

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

Very accomplished. A lot of useful info

Camilla Hammerum, VP, Ipsen, Mar 19

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

Samuel Vandenbussche, Regulatory Affairs Consultant, PhaRA BVBA, Mar 18

Excellent overview - very comprehensive and clearly presented

Sue Tollerfield, Senior Medical Writer, Scinopsis, Mar 18

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 18

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 17

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, Mar 17