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Prescription for Success: Streamlining Meetings to Craft Compelling Regulatory Documents

Prescription for Success: Streamlining Meetings to Craft Compelling Regulatory Documents

29 Feb 2024

February 29, 2024 | Evan DuBose, PhD and Kelsey Gray, PhD – Clinical Research Scientists | Medical Writing Services


Does scheduling meetings feel like a circus act between juggling multiple calendars and balancing competing priorities? If so, you will likely appreciate the value of meaningful meetings that are both effective and efficient.

Let’s dive into general meeting tips and detailed strategies to enhance common types of meetings for regulatory medical writers.


General Meeting Tips

For any type of meeting – whether it be a meeting with a client or an internal meeting with colleagues – it can be helpful to remember the following:

  • Preparation is the key to success. At minimum, even a few minutes of preparation immediately prior to a meeting makes you a more effective participant. In this case, focus on a few key principles: what do you absolutely need to communicate before the meeting ends and what information do you not want to leave this meeting without? When leading a meeting, reserve additional time for meeting preparation
  • What’s on the agenda? If you are leading the meeting, enhance efficiency by emailing an agenda in advance. This will support the attendees with their preparation and encourage them to be active participants.
  • Do or do not, there is no try. Clearly establish action items during the meeting, including target completion dates and a point person assigned to each task. As a meeting leader, make note of these details to include in a post-meeting follow-up email.
  • Don’t forget to follow-up. Before the meeting ends, it is important to remind attendees of next steps. This ensures that team members adhere to timelines and outstanding action items are completed. Next steps can be stated at the end of the meeting and reiterated in follow-up emails with meeting minutes and action items highlighted.

Medical Writing Specific Meetings

In regulatory medical writing, three of the most common types of meetings are Kick-off Meetings (KOMs), Results Interpretation Meetings (RIMs), and Roundtables (RTs).

  1. A KOM is important to hold prior to the start of any clinical or regulatory document. The purpose of this meeting is to establish the key messaging, identify any nuances in the study or drug program, determine timelines and regulatory deadlines, and confirm lists of team members and approvers of documents.
  2. A RIM for data-driven documents, such as Clinical Study Reports (CSRs) or Integrated Summary documents for New Drug Applications (NDA)/Biologics License Applications (BLA) submissions, is conducted once final data are available and is typically a half-day or day in length. While this may seem like a big investment of time, it’s worth it! At this meeting, the team reviews the data and (as the title implies) interprets the meaning of the results. Reserving time for in-depth discussion of data interpretation helps to ensure clear and consistent messaging throughout the CSR and related submission documents. Depending on the company, you may come across many alternative names for this type of meeting, such as Data Interpretation Meetings (DIMs) and Clinical Interpretation Meetings (CIMs).
  3. A RT meeting is conducted for the documents mentioned above (and more!) following team review of each draft of a document. The purpose is to discuss any of the team’s review comments that warrant group discussion/consensus and determine edits/action items for the next draft or document finalization.

Kick-off Meetings

  • Getting started. Prior to the meeting, create an agenda to ensure general project management questions concerning the timelines are answered and to address project specific details. If the team has provided any regulatory deadlines prior to the meeting, generate tentative timelines to share with the team during the meeting to jumpstart the timeline discussion, and ultimately the project.
  • Be direct. To ensure you have the information needed to start this project, ask direct and specific questions. At the conclusion of this meeting, it should be clear what source documents and models to use for authoring, if the project is on a standard or abbreviated timeline, and how many drafts and/or rounds of review the team is expecting. This is also the time to confirm who the key decision makers are if you should encounter any issues along the way during the project.
  • Team effort. After the conclusion of the meeting, send the agenda with the team decisions and meeting minutes appended. Be sure to also highlight any action items in your follow-up email to the team and provide names of responsible persons and deadlines for completion of the action items. If the KOM is for a CSR, be sure to also send the meeting minutes, specifically appendices decisions, to the narrative writers and the publishing team so they can begin work on the necessary appendices.

Results Interpretation Meetings

  • Review the data in advance. Take time to look at the study results prior to the meeting and compare these with the planned data collection to determine whether there were changes to the analysis. If the RIM is for a document that includes in-text data tables, add these data to the document in advance when possible, so that it can be viewed by the group during the meeting.
  • Annotate, annotate, annotate. To stay organized, add review comments throughout the document to make note of your interpretations, comparisons, and questions about the data presented.
  • Think globally. Be sure you are clear on the team’s vision for the overall organization of the document, which treatment groups or dose groups to compare, which time points to present/discuss in text, or any data tables that should not be discussed in text. Establishing clear global decisions for the document early in the authoring process can avoid substantial potential re-work later in the project.

Roundtable Meetings

  • Prioritize team comments in advance. Create a version of your document for the RT with additional information added to the team comments as needed for meeting discussion. It is helpful to also create a separate document/agenda listing high priority comments for discussion that includes details such as comment page number, document section, and commenter(s) name.
  • Where am I? Use the navigation pane or bookmarks to provide a visual showing what section of the document is being discussed at any given time. It is also helpful to verbally state when the topic is transitioning from one section to another. This will alert meeting attendees as to when sections most relevant to their area of expertise are being discussed.
  • Inclusive conversation. Determine who the key decision makers are and bring them into the discussion as needed. Notice which team members are prone to speaking up or keeping quiet and be sure to take this into account when facilitating discussion. To confirm all participants are on the same page throughout the meeting, one simple method is to repeat/rephrase ideas back to the team and ask the primary contributors to verify they have been accurately captured.
  • Help me help you.  Unleash your inner detective – seek out any missing pieces of information that you need to make updates for the next draft. Ask clarifying questions to ensure complete understanding of data and messaging before the meeting ends.

We hope you have found these tips helpful! If you have questions, or want to enlist us to write your documents and run meetings, all of us at the Syner-G BioPharma Group would love to help. Don’t hesitate to contact us!

About The Authors

Evan Dubose, PhD

Clinical Research Scientist II

Evan DuBose, PhD is a Clinical Research Scientist II at SynerG Biopharma Group. Prior to joining SynerG Biopharma Group, Evan gained experience in clinical trial development and regulatory affairs at Cato Research (now Allucent) where she worked as a regulatory strategy intern.

Evan has over 5 years of experience in regulatory medical writing and project management. Evan’s regulatory writing experience includes writing CSRs, IBs, and protocols in therapeutic areas which include neurology and immunology. Evan has over 10 years of experience conducting, presenting, and publishing basic medical science and clinical research.

Evan received a BS in chemistry from Spelman College and a PhD from the UNC-Chapel Hill Department of Pharmacology. Evan’s dissertation work focused on identifying novel treatment modalities for metastatic melanoma to overcome intrinsic and extrinsic resistance to current therapies. In her time away from work, she enjoys crafting and traveling. She also loves attending basketball and baseball games.

Kelsey Gray, PhD

Kelsey earned her PhD in Genetics and Molecular Biology from UNC Chapel Hill. Experiences that followed include a postdoctoral fellowship with the Emory-Tibet Science Initiative, a Fulbright-Nehru Fellowship at Drepung Loseling Science Center in south India, an Assistant Professorship at Chapman University, and developing online science courses for Tibetan Buddhist monastics. After completing the Syner-G Medical Writing Fellowship in December 2023, she has continued the work in her role as a Clinical Research Scientist I.