So, you have an inspection coming up. Panic sets in, but that doesn’t have to be the case. With some practical planning and prep, your firm can be sure to have a positive experience. Here are some tips for ensuring that successful outcome:

REVIEW WHAT THE AGENCIES KNOW...

The Merriam-Webster dictionary defines foreshadowing as “an indication of what is to come.”  In many ways, regulatory agencies foreshadow what is important for them to inspect when they evaluate a company’s pharmacovigilance department.

Clearly, having a view into what...

DSN was invited to attend the “Leveraging Real-World Treatment Experience from Expanded Access Protocols” event at the FDA Headquarters in Silver Spring, Maryland recently. At this event, the team learned about numerous advancements in Expanded Access (EA) that will be...

November 15, 2018

Regulations are a part of the fabric of the pharmacovigilance industry and the pace of change is only accelerating.  Having just returned from the 2018 Foresight Argus User Group Convention in Washington DC in late October, there were several key updates that will have...

September 13, 2018

 UPDATE:  As a follow-up to our post below, DSN’s offices and team were fortunate and suffered no damage. DSN did not have any interruption in case processing or deliverables. We resumed functioning under standard procedures as of Tuesday, September 18, 2018. As you pr...

April 18, 2018

Imagine this all-too-common scenario.  You are the head of a mid-sized pharmaceutical company and one of your most successful post-marketed drugs is up for its annual Periodic Adverse Drug Experience Report (PADER). Upon draft of this required annual report, you learn...

March 28, 2018

DSN is pleased to announce the addition of industry veteran Joseph Knight-McKenna to the newly-created role of Director of Quality and Compliance.

"We're excited to welcome Joe to our DSN team," said Molly James, DSN President.  "He brings world-class quality experience...

Websites can be a window into an organization; what their culture is like, their mission & values, team chemistry in addition to their portfolio of solutions.  We hope you find our newly-refreshed DSN site to be dynamic, easy to navigate, and sprinkled with some action...

Please reload

Recent Posts

Please reload

Archive

Please reload

Tags

Please reload

©2018 by Drug Safety Navigator. All rights reserved. Web design by Fuel Marketing Group.