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What I Learned at the 2017 DIA RSIDM Conference

March 23, 2017 | B J. Witkin, Senior Manager | Regulatory Operations

I was fortunate enough to attend the 2017 DIA Regulatory Submissions, Information, and Document Management (RSIDM) Forum again this year. As usual for this conference, I learned a lot and got a lot out of it.

The big news this year was…the lack of big news. Let me explain.

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Emerging Key Concepts in Biosimilar Development

March 8, 2017 | Kathryn Tworkoski, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Biosimilars are a relatively new class of therapeutics. To date, only 4 biosimilars have been approved by the FDA (ZARXIO™, INFLECTRA®, ERELZI™, and AMJEVITA®); 3 of those 4 approvals occurred within the past year, and all 4 approvals occurred within the past 2 years! In this post, we’re going to take a quick look at the FDA’s current thoughts on biosimilar development, as well as a few key concepts in the field.

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University Resources for Aspiring Scientific and Medical Writers in the Research Triangle Park Area

February 22, 2017 | Kathryn Tworkoski, PhD, Clinical Research Scientist II | Medical Writing Services

Finding a job is hard—finding a job in a new field can be even harder. As someone who recently broke into the field of medical writing I’m familiar with the associated challenges, but I can also tell you that the reward is more than worth the work!

Image courtesy of Renjith Krishnan at FreeDigitalPhotos.net

IMPACT recently created a series of blog posts to help others make similar career transitions by highlighting local resources available to aspiring scientific and medical writers.

Previous posts discussed professional networking tips, how to use social media to make your transition, and professional organizations for emerging medical writers.

In this post, I’ve compiled a list of useful programs and opportunities provided by local universities in the Triangle area of North Carolina. Italic text denotes opportunities that are available to everyone, even people not affiliated with a university.

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Professional Organizations for Emerging Medical Writers

February 8, 2017 | Jacquie Powell, PhD | Medical Writing Services

Attending professional networking events can seem intimidating, especially for graduate students and postdocs with limited professional experience outside of academia. This post provides a list of great professional organizations that some of the folks here at IMPACT have found to be particularly helpful, both nationally and in our local Research Triangle Park (RTP) area.

We hope you find this list helpful, and let us know if we missed anything!

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How to Use Social Media to Transition into Medical Writing

January 25, 2017 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Medical Writing Services

In the previous blog post, we shared advice on face-to-face networking for people (like you!) who are looking to transition into a medical writing career. In this post, I break down some of the available social media resources and pass along some advice I learned along the way to my current role at IMPACT.

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