In my latest blog, I likened the bio-pharmaceutical submissions process with applying for a
mortgage: you need to keep track of many documents, submit everything required, and maintain detailed records of phone calls and emails. The point is that an application to a regulatory authority is not a specific event, but a continuum of submissions along with related correspondence and updates. The intent is for the continuum to create a positive and convincing story about the drug: its development, experiments and evaluations, analyses and proposed benefits to the public.
According to the report “Managing Regulatory Information as a Corporate Asset – Industry, Health Authority, and Vendor Trends” based on an industry study conducted by Gens and Associates Inc., bio-pharmaceutical companies are revising their business and technology plans for global submission management. The report highlights an increasing focus over the next several years on health authority communications. As Managing Partner Steve Gens writes, “… the ability to provide consistent information across global Health Authorities is critical and difficult to achieve.”
Making adjustments in this area will require a holistic view of all submissions, along with fast access to agency correspondence concerning every product the company has in the market. Agency representatives will assume that Continue reading →
If you’ve ever applied for a mortgage or refinanced your home, you know how document
intensive the process can be—appraisals coming in from one source, bank statements from another, employer verification from yet another, and so on. You need to keep track of all these documents, make sure you’ve submitted everything required and maintain detailed records of phone calls and emails.
The process for submitting a drug application to regulatory authorities is much like the scenario of a mortgage application. Bio pharmaceutical companies have to keep a current, complete and concise record of all their drug applications with the government agencies in each market of the world. That requires a record of exactly what was submitted, plus a thorough collection of correspondence from the first contact to the last update. The challenge is to know what was submitted, and when.
If the agency is in a market where you rely on contracted affiliates to know the local regulations, submit applications and maintain an Continue reading →
Stephen O’Leary, the Executive Vice President and COO of Chicago-based Controle has become something of a ringmaster, explaining the benefits of his particular brand of Defensible Deletion: smart and responsible solutions that purge an organization’s unneeded legacy data to improve efficiency, smooth workflow, mitigate risk, and enhance the bottom line.
It seemed to me that Stephen might find it difficult promoting this concept in a culture of cheap storage space, with people trained to save everything. But he says the opposite is true.
“Companies are coming to us. CIOs are leading the charge, telling us how data buildup is paralyzing them, how their systems are collapsing under the weight. They need a solution. But they’re also wary. They want to do this right.”
And that’s the hard part.
Proclaim a “keep it for 2 years, then delete” email policy, and you risk losing valuable business assets and running afoul of compliance and eDiscovery needs (not to mention the extra Continue reading →
As I have commented in a previous blog, the DIA Annual Meeting this year was in San Diego. The meeting was excellent but perhaps I should have stayed over a few days to enjoy the weather at the beach.
There were several sessions that I enjoyed what I learned and perhaps you will too. As an overall comment, I noticed a considerable shift in exhibitors from the past where the floor was overwhelming with CROs. It was much more balanced this year with a variety of representatives from many vendors serving the industry. This is a positive change.
There were 13 countries who sent representatives from their agencies to the meeting. Two panel sessions focused on International Collaboration between Regulators. The key take-away for me was the Continue reading →
Under any circumstances, transferring vast amounts of data into a new Document Management System can be a long and complicated process. Careful preparation is essential, along with specialized expertise and the proper migration tools. Getting it wrong carries high financial risk.
But we all know that the challenges become ever more daunting in a heavily regulated environment, where each bit of data is subject to specific rules and compliance parameters governing how documents are created, modified, stored and migrated. Perhaps nowhere is this environment more challenging than in Life Sciences, where everything is watched, the rules are strict, no wiggle room exists, and mistakes can Continue reading →