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 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 help ensure teams are following these, looking for ways to handle the ever more complex studies that are being designed, the importance of focusing on the regulatory objectives of a study over more academic pursuits, the value of using the Transcelerate template to get more standardization across the industry, and the importance of preparing protocols that communicate clearly and effectively not only to help users find the information they need but also to ensure teams are aligned on the full intentions of the study and for downstream use of the protocols in writing study reports and ultimately dossiers.
EPISODE 13: Q&A WITH TRILOTALK – Focus on CSRs
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 leave a comment with your questions for future sessions of “Q&A with TriloTalk”.
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 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.
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.
EPISODE 10: THE IMPORTANCE OF STYLE GUIDES
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 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.” – Barry Drees
EPISODE 9: THE ETHICS OF MEDICAL WRITING
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 are deep-rooted in the profession of medical writing.
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.
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.
EPISODE 6: APPRENTICING MEDICAL WRITERS
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.
EPISODE 5: LAY SUMMARIES
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 Dr. Lisa Chamberlain James and Dr. Barry Drees as they discuss their knowledge and experiences in writing Lay Summaries.
EPISODE 4: THE POWER OF GOOD REVIEW PRACTICE
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 focused review process leads to a transformational change in how drugs get approved.
EPISODE 3: THE VALUE OF MEDICAL WRITING
“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 writer brings to the table.
EPISODE 2: THE ROLE OF AI IN MEDICAL WRITING
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 as medical writers. You will discover how AI will make writing clinical documents not only faster and more interesting but will aid with the analysis and eliminate human error. Get a sneak-peek into the coming revolution in medical writing.
EPISODE 1: LEAN MEDICAL WRITING
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 is more and the importance of giving answers to the questions posed by studies, rather than just spewing data. Lean writing is at the core of how to take aim at inefficient medical writing.