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Welcome to the November-December 2018 edition of The Protocol Link Newsletter! It's hard to believe the holiday season is quickly approaching, which means this will be our last newsletter of 2018. In this issue, we bring you up-to-date with noteworthy news you may have missed, provide some great industry articles written by our own Protocol Link team members, and conclude with a Word From Our Staff. We hope you enjoy the latest edition of our Newsletter and we look forward to hearing from you!

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NOTEWORTHY LINKS

New CDRH Learn Module: How to Study & Market Your Device ------------------------------ New Efforts to Advance the Development of Generic Copies of Complex Drugs to Improve Patient Access to Medicines ------------------------------ Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements (Draft Guidance)

WHAT'S NEXT FOR US MEDICAL DEVICES IN 2019 Authored By: Christine Shumard-Sauer, Ph.D.

The Center for Devices and Radiological Health (CDRH) at the FDA recently announced the list of draft and final guidance documents it plans to issue in 2019. Since FDA guidance explains the Agency’s interpretation of, or policy on, a regulatory issue, it is interesting to review this proposed list to determine the Center’s priorities and where they are planning to focus their efforts in 2019.

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ENVIRONMENTAL MONITORING: CHALLENGES IN ANALYSIS OF NONVIABLE PARTICULATE DATA Authored By: Dale Kelley

There has been a heavy focus over the past few years on the analysis of microbiological environmental monitoring data including: Parenteral Drug Association (PDA) revision of Technical Report No. 13 (Fundamentals of an Environmental Monitoring Program), updating USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments, and the continued issuance of FDA related citations. All these provide guidance on methods in evaluating data and drive organizations to schedule and perform analysis of the microbial environmental monitoring data at regular intervals to set and revise Alert and Action levels.

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BECOME A CHAMPION OF CHANGE Authored By: Scott Buckely, PMP

In October, I accepted the opportunity to attend Project Management Institute's (PMI’s) Global Conference—held this year in Los Angeles, California. I have been a member of PMI and a holder of the PMP certification for years but never joined fellow Project Managers at such a large event until now. The 3-day conference exceeded my expectations and served to reenergize my passion for Project Management. The conference theme was "Champions of Change" and it provided me with fresh ideas and solutions to positively influence change in my workplace and our clients’ workplace.

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A WORD FROM OUR STAFF

At the time I joined the Protocol Link team, I had no idea the impact this company would have on my life--both professionally and personally. Over the past six years, I have traveled for projects to locations I never dreamed of going, developed a variety of skill sets, gained confidence, and built valued relationships. What is it that truly makes Protocol Link unique? We pride ourselves in being able to work seamlessly with our clients, developing relationships and trust that are key to making a project work while providing the best service possible. I am proud of the contributions I have been able to make, and I know this would not have been possible if this organization did not share my values and drive in always going above and beyond--no matter how small the task may seem. It's this extra care and effort, coupled with our attention to detail and unique expertise, that has led to Protocol Link's success over the past 22+ years. I look forward to what my next six years (and beyond!) brings. Bryn Domin Technical Specialist, Protocol Link

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