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Welcome to the May-June 2019 edition of The Protocol Link Newsletter! In this edition, we present some noteworthy links while our Protocol Link team members provide insight into current industry trends. We look forward to hearing from you!

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Noteworthy Links ---------------------------------------- Office of Product Evaluation and Quality (OPEQ) ---------------------------------------- FDA’s Device Inspections Program Sets FY19 Performance Goals ---------------------------------------- Unique Device Identification: Convenience Kits (Final Guidance) ---------------------------------------- FDA's Efforts to Advance the Development of Gene Therapy ----------------------------------------

Blending Agile and Waterfall Methodologies Authored By: Scott Buckely, PMP

Is your organization looking to get more Agile? Will your teams have a hard time letting go of Waterfall methods? You are not alone, as many organizations look to reap the benefits of Agile without losing the comfort level felt with Waterfall methodologies. The approach? Use a blended method; Waterfall methods for definable work, and Agile for high-uncertainty work.

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FDA Again Delays Combination Product Postmarket Safety Reporting Compliance Dates Authored By: Christine Shumard-Sauer, Ph.D.

On April 23, 2019, FDA published an immediately in effect guidance document, Compliance Policy for Combination Products Postmarketing Safety Reporting (PSMR), which pushes out compliance dates for certain postmarket safety reporting requirements another year. FDA is exercising enforcement discretion for these safety reporting requirements originally published in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR Part 4, Subpart B.

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Lessons Learned: Why You Need a Cross-Functional Team and a Project Manager Authored By: Dale Kelley

The names of the (not so) innocent have been removed to protect their identities. Also, just to be clear, this story is not about you, it is a composite of my experiences with a variety of clients. I’ve seen a lot working as a consultant for over 20 years and heard the phrase, “This must be the most messed up company you’ve ever seen!” many times. The answer is generally no, but sometimes a specific incident does get added to my personal “best examples” list. A recent one has led me to think about cross-functional teams (CFTs) and dedicated project management.

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Service Spotlight: Device and Diagnostics By applying our thorough knowledge of the unique challenges medical device industry, our team can help you build control strategies manage the product lifecycle for domestic and global markets. Our Subject Matter Experts have extensive experience across many device, diagnostic, and combination product platforms. Our hands-on approach and in-person collaborative efforts will ensure that the best strategy is determined, is effectively implemented for sustainable business practices, and it seamlessly fits with your business requirements.

A Word From Our Staff " Protocol Link always strives to be at the forefront of technology, utilizing the latest tools to efficiently deliver projects to our clients. We are excited to announce that 2019 is no different as we continue to invest in new hardware and software technologies. This year, our goal is to reduce our total hardware footprint and become more environmentally friendly. To achieve this, Protocol Link has virtualized our servers, further securing current and future requirements, while providing the highest security. In addition to these hardware upgrades, Protocol Link will continue to strengthen its IT infrastructure by upgrading our ERP System, eCTD Software, and other project management tools, allowing us to continue the premier services and customized solutions that truly differentiates Protocol Link. " Ankit Patel Director, Protocol Link

Protocol Link, Inc. 175 E. Hawthorn Parkway, Suite 210 Vernon Hills, Illinois 60061 USA  www.protocollink.com

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