TriloTalk

Welcome to TriloTalk episode 15, where we will dive into the critical document that plays a pivotal role in pharmaceutical development: The Briefing Documents (or briefing books/packs). Join Barry and Maria as they explore the key elements of well-crafted Briefing Books, their importance in the regulatory process, and how to tailor these documents to the specific regulatory authority. 

In this special session of TriloTalk, Julia and Barry answer questions sent to them by medical writers around the world. The focus of the questions in this episode is Clinical Study Reports (CSRs), data reporting, and analysis. 

Tap into Julia’s and Barry’s vast medical writing experience and make sure to send your questions for future sessions of “Q&A with TriloTalk” to [email protected].

In this episode, Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting talks to Dan Wills, Quality Mark Manager at Patient Information Forum (PIF) about the PIF TICK accreditation and its importance – specifically, what it means for organizations to have this certification mark and what it means for people in their search for high-quality health information.

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.

Restrictive or time-saving? In this episode, Barry reflects on the importance of style guides and how these can serve as a compass to accompany medical writers when deciding on the grammatical or stylistic rules that need to be applied to the documents they are writing. Style guides not only save time (and money) in the writing process but also help improve the document review process. You might also like to listen to Episode 4: The Power of Good Review Practice.

"Style guides will not only improve your writing but greatly improve your review processes."

Rapid dissemination of scientific information, lower standards in review processes, unvetted information.

In this episode, Barry and Art explore the never-ending ethical situations that are deep-rooted in the profession of medical writing.

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.

In this episode, Julia Forjanic Klapproth - Senior Partner, and Maurice Löwens - Medical Writing Manager at Trilogy Writing, discuss how experienced medical writers can streamline the planning and writing process, helping the team navigate a minefield of potential problems and letting the subject matter experts spend more time on crafting the messages.

In this month’s episode, Julia Forjanic Klapproth, Senior Partner at Trilogy Writing & Consulting, and Joan Affleck, Head of the Medical Writing Department at Merck, talk about the medical writing training programs at the companies they represent and explore how training medical writers help build a brighter future and lift the entire profession of medical writing. Listen now