Episode 15: How to Streamline Regulatory Authority Meetings: Spotlight on Briefing Books
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...
Episode 14: The Importance of Getting Clinical Protocols Right
In this episode, Julia and Jonathan cover how making people aware of the many new and updated regulations (such as the ICH E8(R1) and the draft ICH M11 guideline) will...
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...
Episode 12: PIF and PIF Tick. What are these and why are they important?
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...
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.
Restrictive or time saving? In this episode, Barry, Senior Partner at Trilogy Writing & Consulting, reflects on the importance of style guides and how these can serve as a compass...
Rapid dissemination of scientific information, lower standards in review processes, unvetted information. In this episode, Barry, Senior Partner at Trilogy Writing & Consulting, and Art, Principal at MedSciCom, explore the never-ending ethical situations that...
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...
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...
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...
Writing for a non-specialist audience represents challenges beyond writing in a simpler language. Writing a fit-for-purpose document for the general public involves lay language, lay presentation, and lay science. Join...
In this episode, Julia and Barry, Senior Partners at Trilogy Writing & Consulting, call for a “revolution and complete overhaul in the way documents are reviewed”. They explain how a...
“Pay me now or pay me later”. TriloTalk episode 3 features Julia and Gretchen Griffin as they talk and discuss the value of medical writing and what a good medical...
Will AI replace or assist medical writers? Join Julia and Barry in this episode as they talk about how AI is going to change the way we write and work...
In this episode, Julia and Barry talk about the importance of lean medical writing to communicate the key messages efficiently. The goal is story, not storage. They discuss how less...
