Topic: Common Technical Document (CTD)

Podcasts

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Episode 11: Taming the Complexity of Preparing CTD Submission Dossiers

Process optimization, effective management, and organisation strategies are all essential components when preparing CTD submission dossiers for drug approval. 

In this episode, Douglas, Senior Partner at Trilogy Writing & Consulting, and Johan Telen, President at Improvement at Work, discuss how implementing well-planned, focused, and robust processes can actively de-risk the critical path and contribute to reducing the time needed for dossier preparation.

TrloTalk at Apple Podcast, Google Podcast, Spotify
Responses to Regulatory Authorities
Episode 8: Responses to Regulatory Authorities

In this episode, Julia and Douglas, Senior Partners at Trilogy Writing & Consulting, discuss how preparing written responses to questions received from regulatory agencies during the review of application dossiers can be decisive to the outcome of the review, and how medical writers can make a substantial contribution to this process.

A Primer for Writing Oncology Dossiers
Episode 7: A Primer for Writing Oncology Dossiers

In this episode, Julia Forjanic Klapproth, Senior Partner, and Maurice Löwens, Medical Writing Manager at Trilogy Writing & Consulting, discuss how experienced medical writers can streamline the planning and writing process of oncology dossiers, helping the team navigate a minefield of potential problems and advising the team on how to present the information with clarity that will direct agency reviewers to what they are looking for and aid the approval process.

Publications

OCT-2022-Cover-Page
How to streamline a complex process: why experienced medical writers will add value to oncology dossiers
Oncology is one of the most common areas of drug development in the pharmaceutical industry. In 2020, many of the new drugs approved by the FDA were cancer treatments. Existing...
Author: Julia Forjanic Klapproth and Maurice Löwens
Journal: Clinical Operations in Oncology Trials Handbook 2022
Date: December 2021
Medical-Writing-Special-Edition-2-Front-Cover
Taming the Complexity of Preparing CTD Submission Dossiers
Process optimisation and effective management and organisation strategies are essential components when preparing CTD submission dossiers for drug approval. “Be prepared.” In his book, Scouting for Boys, Robert Baden-Powell introduced...
Author: Douglas Fiebig, Johan Telen
Journal: Medical Writing Special Edition No. 2
Date: February 2020
Medical-Writing-Special-Edition-2-Front-Cover
Implications of Policy 0070 for the Writing of Clinical Dossiers
EMA Policy 0070 requires the publishing of all clinical reports submitted as part of MAAs, so it is important to highlight what new challenges this may bring for the writing...
Author: Julia Forjanic Klapproth, Jo Anne-Marie Blyskal
Journal: Medical Writing Special Edition No. 2
Date: February 2020
Medical-Writing-Cover-722x1024
The Challenge of CTD Submissions and Responding to Questions from the Authorities
The Common Technical Document is an international standard for the summary documents needed to obtain regulatory approval of medicinal products. These summary documents involve presenting key information drawn from a...
Author: Douglas Fiebig
Journal: Special Edition of International Clinical Trials, ICT
Date: February 2017
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Battling with clinical submissions: War rooms and other tricks of the trade
Submission dossiers - the most interesting and challenging documents for a medical writer.
Author: Julia Forjanic Klapproth
Journal: The Write Stuff, The journal of EMWA
Date: Vol.15, No.1, 2006