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Welcome to our first newsletter of 2018! We hope everyone had a wonderful holiday season and are enjoying the start of the new year.

Our first edition of 2018 has articles written by Protocol Link team members to provide expertise on current industry trends. We review the new draft guidance which describes the Agency's "least burdensome approach", highlight the results of the 2017 PDA Aseptic Processing survey, and analyze effective engagement between project managers and sponsors.
Noteworthy Links

Defining "The Least Burdensome Approach" to Spur Medical Device Innovation

Authored by
Christine Shumard-Sauer, Ph.D.
On December 14, 2017, the FDA issued a new draft guidance that describes the criteria that the Agency plans to pursue the "least burdensome" means of assuring the safety and effectiveness of new devices so that innovations that will benefit patients can reach them quicker.  The "least burdensome approach" is not new; however, recent legislation such as the 21st Century Cures Act in 2016 and scientific advances have prompted the Agency to modernize its regulatory framework and make its review processes more efficient.




2017 Parenteral Drug Association (PDA) Aseptic Processing Survey

Authored by
Steve Weltler
In December 2017, the Parenteral Drug Association (PDA) published an updated survey of the aseptic processing practices currently being utilized by pharmaceutical manufacturers globally. The survey focused primarily on secondary manufacturing processes (finished product filling and packaging) and reflected the feedback of 304 global respondents representing both PDA members and non-members.  The identity of the respondents was blinded to the authors collating and summarizing the results.  The intent of the survey was to assist PDA in understanding and communicating aseptic practices in current use and serve as a useful tool for firms to benchmark and further improve their operational practices.




Successful Relationships Between Project Managers and Sponsors

Authored by
Lokesh Kukreja, Ph.D.
The effective implementation of a project is critical for an organization to achieve its goals and to meet client needs and expectations.  One of the key factors for success in any project is the working relationship between the project manager and the sponsor. A project manager is responsible for planning, execution, and closing of a project working closely with a project team and a sponsor, typically an executive, who clarifies the project goals and provides direction and funding.




A Word from Our Staff

Each time January rolls around, it's hard to believe another year has ended! Our industry continues to provide many opportunities for all of us to grow, improve and innovate, and for this we are motivated and grateful.

2017 was another memorable year at Protocol Link. We continued to expand our team of Subject Matter Experts, formally launched our Project Management Services sector, and continued to provide the premier consulting services that our clients have grown to expect, both domestically and internationally. In the past year, our team was busy across a broad spectrum of pharma, device, and biologics services, supporting our client's growth in areas of mergers and acquisitions, facility additions and expansions, strengthening process reliability and quality systems, and providing practical advice in the ongoing management of global regulatory compliance to meet the best standards of our industry in each business area.

I want you to know how special you are to us, especially at this special time of the year. We wish you all the best, and may your New Year bring health, happiness and success! We look forward to working with you in the upcoming year.

Dipak Doshi
Chief Executive Officer, Protocol Link

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