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IMPACT Employee Honored as the “Triangle’s Finest” by the Cystic Fibrosis Foundation

Research Triangle Park, NC: 7 December 2017 – This fall, IMPACT’s Rachel Cohen participated in the Cystic Fibrosis (CF) Foundation’s annual “Triangle’s Finest” event, a program for Triangle-area men and women committed to professional development and personal growth through fundraising and awareness.

On November 3rd, 4 individuals were honored at the Brewer’s Ball celebration where over 200 attendees gathered at Bond Brothers Beer Company in Cary to celebrate the Triangle’s Finest and benefit the CF Foundation. In addition to Rachel, Caroline Teachey (Chiesi USA), Sarah Stokes (Gluten-Free with Sarah B), and Charles Webb (Starbucks Coffee) were honored by the CF Foundation.

On a gorgeous fall night amidst a casual environment including craft beer, tasty food from local vendors, and auction items galore, Rachel (left) was recognized as the “Triangle’s Finest Young Professional of the Year” after raising the highest amount of the 4 honorees.

In 7 weeks, Rachel raised over $8000 by online fundraising, corporate sponsorship, co-hosting a donation Yoga for Runners class with Arrichion Durham, and receiving a portion of proceeds from events held at Bull Street Gourmet & Market and Wine & Design Durham.

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Why and How to Conduct a Strategic Review of Regulatory Documents

November 16, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing and Corporate Communications | Medical Writing Services

As regulatory medical writers, we are trained on how to write for regulatory audiences, but how often are a Sponsor’s project teams trained to review the regulatory documents we write? At IMPACT, our answer is – as often as possible.

We encourage our project teams, as well as our internal staff, to use strategic review practices whenever possible, to ensure an effective, efficient review. We have trained internal and external reviewers accordingly, both with excellent results.

In this post, we’ll share the keys for an effective strategic review of regulatory documents. Please consider following these tips during your next review and let us know how it goes!

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Meredith Latino, PhD Promoted to Senior Clinical Research Scientist

RESEARCH TRIANGLE PARK, NC: 18 Oct 2017 – In September 2017, Meredith Latino, PhD was promoted to the position of Senior Clinical Research Scientist at Impact Pharmaceutical Services, Inc. (IMPACT).

Meredith joined IMPACT in December of 2012 as a Clinical Research Scientist and worked primarily with one of our strategic partners helping to coordinate the proper compilation of clinical study report appendices. After spending several years in that role, Meredith increased her medical writing responsibilities and quickly developed into a very talented author. In her role as a Senior Clinical Research Scientist, Meredith contributes to an assortment of documents (eg, clinical study reports, Investigator’s Brochures, and New Drug Applications) across a variety of therapeutic areas. In addition to her writing responsibilities, she has become a dedicated, knowledgeable mentor to our newer writers – and is always willing to go the extra mile to help them succeed.

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RAPS Regulatory Convergence 2017: A Recap

October 11, 2017 | Mark A. Cierpial, PhD, RAC; Principal Regulatory Consultant | Regulatory Affairs

The Regulatory Affairs Professionals Society (RAPS) held another successful annual meeting (or “Regulatory Convergence” as it’s called) last month. This year’s Convergence was held at the Gaylord Resort at National Harbor on the DC Waterfront and offered more than 70 educational sessions presented by over 200 expert speakers from around the world. In addition, 135 companies, offering a wide range of regulatory services and solutions, were in attendance in the exhibit hall.

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The Importance of Style…in Regulatory Documents

September 7, 2017 | Ann Brown, Document Services Manager | Regulatory Operations

When I think of style, the first thing that comes to mind is fashion. Being stylish is to wear clothes that are becoming to your size and shape (you look good!) and are functional, that is, they keep you warm in winter and cool in summer. But, style goes beyond clothing or other things like interior design, automobiles, architecture, etc.

In the world of regulatory writing, how your document presents and how it performs are critically important if it is to meet the rigorous standards of electronic submissions to worldwide regulatory agencies.

Three Tenets of Style

Basically, there are 3 important tenets of style when it comes to regulatory writing:

  1. follow a style guide,
  2. have authors trained in the use of Microsoft Word and its associated templates, and
  3. use well-designed templates that contain built-in styles.

In this post, I will concentrate on the importance of well-designed templates and their subsequent impact on an electronic submission. Style guides and training will be covered in a future post. Stay tuned!

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