Presenter: Bart Harvey, MD, PhD, MEd

This workshop is designed for participants who have little or no background in statistics. Elementary statistical concepts needed to understand medical and scientific articles will be covered, including types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and Student’s test. Emphasis will be placed on understanding statistical presentations and on reporting statistical information, not on calculations or mathematical explanations.

Content Area: Core Knowledge

Presenter: Jennifer Bridgers, MS, MWC

This workshop is appropriate for newer medical communicators who are interested in understanding the process for writing clinical study protocols. The teaching style will be primarily lecture with opportunity for discussion. The workshop leader will focus on what regulatory/medical communicators need to know to write effectively a clinical study protocol that is compliant with the International Council for Harmonisation (ICH) guidance. The workshop leader will present the regulatory requirements and introduce how the use of templates can shorten the protocol development duration. Participants will learn how to gather information, manage the review process, and understand who will be using the protocol. Current initiatives in protocol research will also be discussed.

Content Area: Regulatory Writing

Presenter: Damiana Chiavolini, MS, PhD

Content Area: Writing/Editing

Presenter: Art Gertel, PhD

There is now an internationally agreed format for the presentation of an application dossier for a marketing authorization for a pharmaceutical product: The Common Technical Document (CTD). It is accepted by the three participating regulating authorities (USA, EU, and Japan) as well as by other “observer” parties (e.g. Canada). This does not mean, however that there is commonality in the processes required for submission and review, the content of dossiers, nor the way in which reviewers approach the assessment of the dossier. In particular, there are significant differences between the way data are summarized and the approach taken by European reviewers and that taken by their counterparts in the USA. While some of these differences may ultimately evolve to a state of commonality, others likely never will. Participants will be introduced to the legal origins and mandates, and will review some of the labyrinthine procedures associated with preparing, filing, and defending a licensing application. Cultural and practice differences and similarities between the EU and USA will be explored.

Content Area: Regulatory Writing

Presenter: Kelley L. Hill, MS, ELS

Teaching our peers provides opportunities for sharing valuable knowledge, often gained through hands-on experience, but where do you start in sharing this knowledge? This workshop focuses on the skills needed to serve as a mentor, the mentee and mentor relationship, tools that can be used to assess the needs of the mentee, and how to develop a mentorship plan.  Workshop participants will have the opportunity to immediately apply the information shared in this workshop to identify mentor opportunities within their current role and develop an individualized mentorship plan.

Content Area: Career Development

Presenter: Marianne Mallia & Stephen Palmer

Through a discussion of numerous editing and writing examples, you will learn strategies to improve the editing of your own and others’ medical documents, including some finer points of grammar and style. You will apply what you learn through small-group work on editing exercises. The knowledge and skills gained in the workshop should make an immediate difference in your ability to prepare a medical document that is clearer and more concise.

Content Area: Writing/Editing

Presenter: For Pharma and Biotech Executives Who Oversee Medical Writing Teams

Presenter: Genevieve Walker, PhD & JoAnna Pendergrass, DVM

How do you create patient education that includes everyone? Paying attention to your audience and purpose helps you tailor patient education content and design to increase access and readability. You’ll learn key principles of health literacy, numeracy, and plain language to create materials that empower patients, families, caregivers, and consumers.

Content Area: Health Communication

Presenter: Lisa Chamberlain James & Julia Forjanic Klapproth, PhD

The primary goal of writing is to convey information to a target audience. This workshop will explore the fundamental concepts of how a writer can express the same story to vastly different audiences. The workshop will introduce, actively explore, and exercise the different writing styles commonly used in medical writing in addition to emphasizing which style is most effective for each audience and why. 

Content Area: Writing/Editing

Presenter: Cyndy Kryder, MS, MWC

The use of images to convey information continues to grow exponentially, and with good reason. Visual communication offers important advantages over text: delivery of a clear, unified message, ability to relay a message quickly, and better audience retention of content. Medical communicators tend to think of their expertise as writers, but to stay current and meet their employers’ and clients’ needs, they must learn to think—and communicate—more visually. In this workshop, you’ll learn about the science behind visual communication—why we need to present information visually and the benefits; trends in visual communication, such as infographics and visual abstracts; tools for content visualization; and best practices for creating effective visualizations that are appropriate for the audience and message. Throughout this workshop, you’ll have opportunities to stretch your creative muscles and work in small groups to practice communicating visually.

Content Area: Core Knowledge

Presenter: Art Gertel, PhD

Medical Writers, by virtue of their role throughout a project, with particular focus on the deliverable at the near the end, often inherit project management responsibilities. Whether formal or not, the medical writer is often the de facto project manager, responsible for ensuring the timely delivery of source documents and input from their colleagues. This workshop will cover project planning, monitoring, and execution, and will highlight the required communication skills and the challenges faced during the project lifecycle. Discussion will include project management theory and practical applications, both within the context of a matrix organisation, and as an independent providing services to clients. A medical writing group may also adopt these practices to better control their own destiny. This workshop will be a combination of lecture and in-class exercise, and will include discussions based on analysis of the scenarios presented in the homework. While the majority of the presentation will be didactic, there will be opportunity for attendees to share their experiences and ask questions throughout the presentation.

Content Area: Regulatory Writing

Presenter: Kim Jochman, PhD, RAC

In today’s medical writing environment, medical writers are routinely faced with writing about highly complex studies and overwhelming amounts of data. When writing a deliverable, be it a protocol, clinical study report, poster, or peer-reviewed manuscript, it is imperative to develop a document that focuses on the key messages. This workshop provides recommendations on how to get out of the way of the data and implement various lean authoring techniques to ensure that the target audience comes away with the intended key messages. In-workshop activities: participants will engage in exercises to revise text to make it more fit-for-purpose, more lean and message-driven, more concise, more effective, and less biased.

Content Area: Regulatory Writing

Presenter: Jennifer Bridgers, MS, MWC

Effective narrative composition is a skill. Well written narratives are cohesive, concise, and clear. This workshop is appropriate for moderately experienced writers who want to develop the skills needed to compose top quality narratives. Key elements in safety reporting, correct use of medical language, and organization of data for a well written narrative will be covered. Best practices and realistic constraints will be discussed. This workshop will include interactive exercises to build narrative composition skills.