Regulatory affairs

Everyone agrees that advances in medicine have helped increase the average human lifespan by decades more than it used to be. Thank goodness for that! Few people realize exactly what it takes to “advance medicine” in modern times, however. When talking about selling a new pharmaceutical drug, aka bringing a new pharmaceutical to market, the…

If we will search for RI anywhere we will be getting many results and definitions. The act of gathering and analysing publicly available regulatory information. This includes communicating the Implications of that information, and monitoring the cu

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Careers and Trends in Regulatory Affairs

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Regulatory Affairs is a very important part of regulated industries that manufacture products intended for human use. One such and also the most important is the pharmaceutical industry. Any product cannot enter the market unless and until it is authorized by the concerned

Regulatory Compliance and Regulatory Transformation. Building an innovative compliance risk management program for tomorrow requires an investment today. Depending on the industry sector, the regulatory environment can be a partial or dominant trigger for transformation

Produce regulatory publishing submissions (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US and global requirements, using electronic publishing tools, and an EDMS system. Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of report-level publishing and submission readiness of source documents for submission-level publishing.

Here is an infographic summarizing what is needed to be a PRRC or Person Responsible for Regulatory Compliance. The new EU Medical Device Regulation MDR 2017/745 and IVDR 2017/748 article 15 request that you nominate a person that will be the PRRC. Learn who can be a PRRC and what are its responsibilities. I provide you with Freebies to help you. #medicaldevice #medtech #medicaldevices #regulation #compliance #cemarking #prrc #easymedicaldevice #video #blog #certification #mdr2017745…

Enhance your regulatory affairs career with these 13 SMART goals examples. You can optimize productivity and achieve measurable results.

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Drug regulatory affairs : basic question and answer for interview and exam point of view.

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A recent J.D. Power study found that customers were slow to embrace new technology and continue to prefer human interaction while obtaining prescriptions.

Read "Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices" by John J. Tobin available from Rakuten Kobo. Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs i...

For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to be experimented they should start somewhere. So how to do that? Samantha Alsbury from TOPRA will help us on this new episode. The post Episode 21 – How to master Regulatory Affairs with Samantha Alsbury appeared first on Medical Device made Easy Podcast.

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Pharma Insights Hub - This is the event description. To succeed commercially, pharma and biotech need to formulate a launch strategy that engages the right commercial resource early on, rewrites traditional payment models in partnership with payers, and provides an integrated delivery network that scales up seamlessly, end-to-end. - Date TBD - Location TBD