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5 Professional Networking Tips for Emerging Medical Writers

January 16, 2017 | Jacquie Powell, PhD, and Ashley Godfrey, PhD, RAC, Clinical Research Scientists | Medical Writing Services

We have talked to a number of transitioning scientists who have a hard time understanding why they should engage in professional networking. One postdoctoral fellow summed it up by saying, “I know I should network but it just feels so dirty.” This made us laugh and helped us remember our own disconnect as we were going through the process of leaving academic science to enter the field of medical writing.

In an effort to help others bridge the gap, this blog post provides 5 professional networking tips we have learned along the way.

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IRB Meetings — Beyond The Regulations

December 15, 2016 | Ashley Godfrey, PhD, RAC, Clinical Research Scientist II | Regulatory Affairs

Have you ever wanted to know what goes on at a convened Institutional Review Board (IRB) meeting? What does the board talk about, how is each clinical research study evaluated, and what kinds of questions will the board raise before approving a study?

These were all questions I had when I joined a local IRB at a large institution.

The experience I had serving as a voting board member and discussing clinical research on the other side of the process has provided me with a valuable perspective.

I hope that sharing some of the things I have learned along with providing some general information about IRB regulations will shed some light on the IRB’s process of review.

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Final Rule Confirms, Posting of Study Results on ClinicalTrials.gov Will be Required for Unapproved Products

November 29, 2016 | Hazar Awad Granko, RPh, PhD, Senior Director, Regulatory Affairs | Regulatory Affairs

In a previous post, we told you about the National Institutes of Health’s (NIH) Notice of Proposed Rulemaking (NPRM) on expanded clinical trial registration and results submission on ClinicalTrials.gov. The Final Rule has now been issued and significantly expands the registration and results reporting requirements for clinical trials.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) required Sponsors of certain clinical trials to register on ClinicalTrials.gov, but only required results reporting for trials of drugs, biologics, or devices that were approved, licensed, or cleared by the FDA.

In a push for expanding transparency and advancement of public health, the NIH issued an NPRM in November 2014 proposing to expand these requirements. After receiving over 900 comments from various companies, organizations, and individuals, and nearly 2 years later, the NIH has now issued a Final Rule on clinical trials registration and results reporting.

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Submitting Drug Master File Submissions to Health Canada – Lessons Learned

November 7, 2016 | BJ. Witkin, Senior Manager | Regulatory Operations

Health Canada has recently announced two major initiatives which greatly affect regulatory submissions in general and Master Files (commonly called Drug Master Files) specifically.

First, Health Canada will now require that all electronic submissions (under 10 GB in size, which is most of them) be sent via their Common Electronic Submissions Gateway (CESG) effective January 1st of 2017. Note that this is 4 months ahead of the FDA’s mandate of May 5th, 2017 (see our previous post for details).

Second, Health Canada has released draft guidance on Master Files with very detailed changes to how they are laid out and submitted. It is very different from FDA Drug Master Files; one example is the Applicant’s Part/Restricted Part (as described below). If you haven’t read the guidance and are considering submitting to Health Canada, I urge you to read it.

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RAPS Turns 40 and Holds Successful Annual “Convergence” in San Jose: A Recap

October 12, 2016 | Mark A. Cierpial, PhD, RAC; Principal Regulatory Consultant | Regulatory Affairs

Congratulations to the Regulatory Affairs Professionals Society (RAPS) on turning 40 this year, and for conducting another successful annual meeting (or “Regulatory Convergence” as it’s called) at the end of last month. This year’s Convergence was focused around the theme of innovation, so the location, San Jose, CA, in the heart of Silicon Valley, was the perfect backdrop.

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