Laura Sheppard joins this episode of #CertaraTalks to share highlights from #AMWA2023. Watch below for insights and key takeaways around topics like AI and the evolution of technology in medical writing and the importance of plain language summaries.
Video Transcript:
Hello, everybody. I’m Doctor. Suzanne Minton. I’m a director of content strategy at Sartara, and I’m talking to my colleague today, Laura. Laura, could you introduce yourself, please?
Sure. Hi. My name is Lara Shepherd. I’m the senior director. For regulatory affairs management here at Suttara.
My responsibilities lie within the writing, and oversight for clinical, regulatory, and lay language content for our clients.
Fantastic. And Laura, I hear that you came you just got back from a really exciting conference. Can you tell us about it?
Certainly. Yes. It was wonderful. This year, we attended the Amwa Medical Writing and Communications Conference. It was held October twenty fifth, the twenty eighth, and, Baltimore, Maryland. And it was spectacular.
Awesome. So glad to hear that you had a great time. I feel like every time I open the news these days, talking about AI and technology. Was this a topic of discussion at Amwa?
Yes. It was a major topic in many, many forms of communication.
And while focus is not only on the regulatory writing space, but also on medical communications.
From a AI perspective, I must say there was quite a large, level of interest on understanding what role the medical writer has in the development of the medical and regulatory document content in face of the evolution, right, of technology, either via AI or other automated system.
It’s multidimensional in many spaces, and it is completely changing how we work with our teams to ensure clear and efficient communications.
Absolutely.
I also was thinking, you know, we’re just it’s October thirty first. We’re ending October, which is Health literacy month. So what did folks at Amwa have to say about plain language summaries?
Oh, plain language definitely one of the very hot topics.
You know, as you remember earlier this in twenty twenty three, the EMA came out and, put enforce the requirements around, for regulatory content, you need to have specific content written to address a plain language audience. In addition to the content, written to the regulatory health authority, and those requirements have frankly changed the way that, our clients need to assess how they write when they write and when they need to start planning for these specific two forms of writing because they are very unique and distinguished from each other and required if they’re going to proceed forward with a a child, in the EMA regions.
Absolutely. So, Laura, you’ve talked about some of the required regulatory writing that drug developers need to make sure that they’re addressing. But you also said earlier that medical publications and communications is a big track at AMua. You tell us some of the insights you got from this year’s meeting?
Definitely. It was.
Publications are a vastly immense space. And it’s very exciting for myself and others in this area to see the growth and the development of the, the PLSP. So it’s the plain language summary for publications.
And this is taking those medical communications and helping to write them to address a broader audience. So those could be the patients themselves. It could be health care staff at a physician’s office. Who may not necessarily be as conversant with a publication directly.
I find it very exciting because the aspects of lay language are to share the top line important pieces of information that everyone has worked so hard to achieve in terms of clinical research to to move the pipeline forward and provide more patient information, and ultimately, hopefully, approvals for products available.
Absolutely. I couldn’t agree more, more Laura. I think that patient literacy is so important so that we can help our patients understand the drugs that they’re taking and make sure that they’re taking them to get maximum benefit. Well, thank you so much. It was great talking to you. If you wanna learn more about Laura and her team and how reports, regulatory and medical writing, visit us at certara.com. I’m Suzanne Minton, and we’ll see you next time.
