Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

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)

Course Overview

The Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications.

This programme will present the regulatory guidelines and requirements, discuss practical approaches to developing the content and preparation of the clinical overview and clinical summaries (module 2) and provide an update on the latest information and potential future developments. Associated documents will also be discussed, such as the risk management plan and summary of product characteristics.

Benefits of attending:

  • Latest guidance to ensure you meet regulatory expectations
  • Writing clinical documents for global submissions
  • Preparing separate integrated summaries of efficacy and safety for FDA
  • Content of orphan drug applications, OTC switches, line extensions and safety-related labelling updates
  • Writing a risk management plan that is consistent with the CTD
  • The place of the clinical overview and summary in lifecycle knowledge from initial IB to PSUR, and how they support the changing 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 Common Technical Document 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 Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)
  • Writing an overview and summary to support the SmPC and labelling changes

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

You may also be interested in

Previous customers include...

  • AbbVie Ltd
  • Angelini ACRAF s.p.a.
  • AstraZeneca
  • Bavarian Nordic
  • Disphar International B.V.
  • Dr. Victoria Howe
  • Eurodrug Laboratories B.V.
  • Galapagos
  • Galderma R&D
  • hameln pharmaceuticals ltd
  • INNATE PHARMA
  • Ipsen Biopharm Ltd
  • LFB Biotechnologies
  • Martindale Pharma
  • Medac GmbH
  • Merck Sante s.a.s.
  • NDA Regulatory Science Ltd.
  • Novartis Consumer Health SA
  • Omega Pharma Ltd
  • Orion Corporation
  • Pfizer Limited
  • PhaRA BVBA
  • RB Healthcare (UK) Limited
  • Scinopsis Ltd
  • TEVA UK LTD
  • Tigenix NV
  • Trilogy Writing & Consulting GmbH
  • UCB Pharma SA
  • United Therapeutics Europe Ltd
  • Zambon S.p.A.

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

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

Samuel Vandenbussche, Regulatory Affairs Consultant, PhaRA BVBA

Excellent overview - very comprehensive and clearly presented

Sue Tollerfield, Senior Medical Writer, Scinopsis

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

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