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Topic: Common Technical Document (CTD)

Think-Tank-October-2019-Massachusetts-
Taming the Complexity of Preparing CTD Submission Dossiers: Science meets Logistics
October 25, 2019 | Massachusetts, US Trilogy hosted a discussion on how to make the process of writing and coordinating a CTD submission dossier as efficient as possible and, ultimately,...
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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.
Date: July 2022
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...
Date: April 2022
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...
Date: March 2022
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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
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Taming the Complexity of Preparing CTD Submission Dossiers: Science Meets Logistics
Trilogy hosted its second virtual Think Tank on how to make the process of writing and coordinating a CTD submission dossier as efficient as possible and, ultimately, reduce the stress often associated with this activity.
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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
Think-Tank-Dossiers-London-2019 (1)
Taming the Complexity of Preparing CTD Submission Documents: Science Meets Logistics
April 26, 2019 | London, UK Trilogy hosted a discussion on how to make the process of writing and coordinating a CTD submission dossier as efficient as possible and, ultimately,...
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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