WS #01: Essentials of Copyediting

10/23/2024 9:00 AM - 12:00 PM

Presenter: Loretta Bohn, BA, ELS

Intended for beginning copyeditors, this workshop will focus on basic copyediting skills. Copyediting is the process by which a manuscript is prepared for publication by revisions that ensure clarity, accuracy, and consistency.  Participants will learn the elements, principles, and processes involved in copyediting for scientific and medical publications.  Specific exercises will enable participants to identify typical copy problems and compare various editorial choices.

Content Area: Writing/Editing

WS #03: Project Management: A Practical Approach to Document Leadership

10/23/2024 9:00 AM - 12:00 PM

Presenter: Elizabeth Brown, MS, PMP

With the ever-evolving role of the medical writer shifting from “document writer” to “document leader,” knowing how to successfully lead a team-based deliverable is just as critical as the writing itself. In this workshop, attendees will discover a practical approach to medical writing projects by applying project management skills and methodologies. Through a combination of presentation, demonstration, and hands-on activities, attendees will build their Project Management Tool-Kit with essential tips and effective tools that can be immediately implemented to successfully lead writing projects even when challenged with difficult stakeholders and accelerated timelines.

Content Area: Regulatory

WS #05: Usage: Choosing the Right Word for the Job

10/23/2024 9:00 AM - 12:00 PM

Presenter: Stephen Palmer, PhD, ELS

Designed for moderately experienced medical communicators, this workshop focuses largely on words that are commonly misused in medical writing. We will discuss what is considered correct usage in the academic medical literature (mainly according to AMA style), as well as how to choose words for maximum precision and conciseness. The workshop format includes lecture and group exercises and time for participants to raise questions about usage.

Content Area: Writing/Editing

WS #06: Comparing and Contrasting US and EU Regulatory Processes

10/23/2024 1:30 PM - 5:00 PM

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

WS #08: Writing the Investigator's Brochure

10/23/2024 2:00 PM - 5:00 PM

Presenter: Kathy Spiegel, PhD

This workshop is intended for beginner to moderately experienced writers in the pharmaceutical industry who want to improve their understanding of the investigator brochure (IB). The workshop leader will focus on the regulatory and informational needs of the audience and how to use best practices to communicate information on the drug. Relevant regulations will be reviewed, and required topics discussed. The evolution of the IB from phase 1 to phase 4 will be elucidated. A discussion will focus on how to prepare an IB using subject matter experts.

Content Area: Regulatory

WS #10: Mentoring Other Writers - How to Begin

10/23/2024 2:00 PM - 5:00 PM

Presenter: Kim Jochman, PhD

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

Executives Forum with Lunch & Reception, Sponsored by Certara (By Invitation)

10/23/2024 11:00 AM - 5:45 PM

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

WS #12: How to Interpret and Write About Clinical Trial Data

10/24/2024 2:00 PM - 5:00 PM

Presenter: Kim Jochman, PhD, RAC

When writing about clinical trial data, the days of simply repeating numbers from a table have passed. Whether you are writing about data for regulatory reviewers, journal readers, patients, or other groups, your audience wants and deserves to read interpretations about what the data mean. But how does one write content that accurately and effectively interprets the data? In this workshop, the science (and art!) of interpreting data from clinical trials will be discussed and practiced, with a focus on understanding different statistical approaches to gain confidence in what can (and cannot) be said about the data. Techniques for getting stakeholder input and alignment on key interpretations and messages will also be presented. Embrace your role as a data interpreter with the knowledge and ability to lead your team through the creation of clear, accurate documents that go beyond the numbers in a table.

Content Area: Regulatory

WS #14: Leadership Development for Medical Writers

10/24/2024 2:00 PM - 5:00 PM

Presenter: Angela Russell Winnier, PhD & Julia Forjanic Klapproth

In our current global, remote working environment, the value of medical writing depends on excellent interpersonal, active listening, and influencing skills in addition to strong technical writing ability. Much of our existing training programs focus on technical/knowledge-based competencies. But, developing medical writers to be leaders (of a project, of other writers) should be an essential focus. As for any role, good leaders do not emerge fully formed from the seed of a medical writer. There is a specific skill set needed to make a great leader/people manager capable of successful collaborations with cross-functional, global teams and influential development of other medical writers. This workshop will summarize the characteristics of the training environment that promote development of these skills and provide behavioral tips and real-world examples to illustrate the skill set and characteristics desired in a medical writing leader.

Content Area: Leadership/management

WS #16: Do More with Less Faster: Project Management for Medical Communicators

10/25/2024 9:00 AM - 12:00 PM

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

WS #18: Summarizing Clinical Safety Data for a New Drug Application

10/25/2024 9:00 AM - 12:00 PM

Presenter: Jennifer Bridgers, MS, MWC

This workshop is appropriate for regulatory/medical communicators who are familiar with writing clinical regulatory documents but are new to submissions. 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 effectively write the high-level clinical safety documents required specifically by the Food and Drug Administration for US New Drug Applications (NDAs), namely the Module 5.3.5.3 Report of Integrated Safety Analysis (ISS) vs the Module 2.7.4 Summary of Clinical Safety. Associated regulations and guidelines will be discussed, as well as the source documents and other tools needed for generating these documents.

Content Area: Regulatory

Roundtable Discussions with Breakfast

10/26/2024 8:30 AM - 9:45 AM

Presenter: Click description for details

View full roundtable descriptions and presenter information here. AMWA Staff will reach out to the email address you've provided within 5 business days to select your roundtable.