regulatory information management

Pharmaceutical companies are placing even more importance on the pharma regulatory aspects of data and information management and how efficiently information is translated to drug market applications. Neil Gow, Head of Records Management for UCB, joins Helen Winsor from Pharma IQ, to discuss the challenges to efficient and effective information management in pharma and biotech.

Pharma IQ: Neil, welcome to the show. How are you today?

N Gow: I’m very well, thank you.

Pharma IQ: Great that you could join us. The first question that I’d like ask you is, how does your role in records management overlap with that of data management in regulatory departments?

N Gow: Well, many of the source documents that are used for submissions in regulatory submissions, are formal GXP reports and documents… my team have the responsibility to ensure that these types of document are well managed in the UK. Now the new regulatory Electronic Document Management System (EDMS) means easy access to the source documents for all new documents. But for the old paper documents, we still operate on a fetch and copy basis.

Pharma IQ: Sure, okay, and having had previous experience working on the pharmaceutical regulatory side, what would you say, Neil, is the biggest challenges for those departments right now?

N Gow: The big change in the last three years obviously has been the move to electronic submissions. I think that’s going to keep posing further challenges, because I just feel that the agencies are going to continue to require more and more in what they want in this format of submission. In the industry, we’re just going to have to keep adapting to that. We’ve now got an EDMS and regulatory publishing solution in place.

The biggest challenge for that is to actually ensure compliance within the organisation. So documents need to be written or imported in the system, they have to be written using the appropriate template and meet the requirements of submission readiness. A big one for me personally is how we manage documents that aren’t actually within the scope of that system. Some of those are still very important to the organisation and we have to continue to manage those as well as we did before.

Pharma IQ: Are you actively looking at new data solutions all the time?

N Gow: It’s being forced on us to a large extent. If you look at what’s happening now, data at all stages of the R&D process are increasingly being generated or stored in electronic systems. Gone are the days when you could just print out raw data onto paper and say this is an original; you just can’t do that anymore. So management of electronic data is really becoming the major issue for records managers these days.

Pharma IQ: How are you and your company solving these types of challenges?

N Gow: The compliance issue I mentioned is a topic on its own and it’s really the case of constant training, support, cajoling, working with the users; it helps to have really committed individuals out there in the user communities. They’ll fight the cause and they’ll also take it up to their management, because the other thing you need is strong management to make this kind of thing work. Regarding the e-data issue, really there, you have to keep up with the times, so I can go on conferences, share experience with other record managers in the industry. We read the guidelines from the regulatory agencies; they’re not always that helpful.

For example, the Food and Drug Administration has issued a guideline saying that if you wish to scan paper and throw it away and only keep the electronic copy, it must be validated. The process must be validated. There’s nothing there to tell you what the expectations are, what that validation should be. So, at the end of the day, you have to make your own risk assessments and justify your processes and hope that eventually common industry practices would evolve which we can then all follow.

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Pharma IQ: Now how did you choose your latest vendor?

N Gow: It was important to UCB to obtain a system that could be used off the shelf. We didn’t want to go about customising it and doing lots of configurations to make it work. So we produced our requirement specifications and we really looked at the vendors who were offering what you’d call a best practice product and assess those against the requirements that we had. We basically chose the one we use based on those assessments. Also what’s more important obviously is the company and the vendor to continue to support the product. So, that was a major factor in our choice.

Pharma IQ: Absolutely, another question that I have for you is: how can your department work more effectively with the regulatory departments?

N Gow: I like that question. It’s always about communication. We all know the regulatory departments work to some pretty horrendous deadlines, and that does have an impact on everybody else’s needs to input into that. So we need to know what’s going on. The other thing is they need to know how we work, so that their requests of us are realistic. They do occasionally still ask us to do things that aren’t our responsibility and then we have to explain and go through the hoops. Having said that, I’ve been a member of the project team for EDMS that was led by Regulatory and Regulatory drove the project. That helped me develop some really useful contacts, on sites throughout the world and they know me well. That’s important now because UCB is a globalised organisation. Documents we manage here will be used elsewhere in the world; it’s good for them to know who to come to.

Pharma IQ: Yes. Now just to round off, Neil, I understand that you’re going to be presenting at our upcoming Pharmaceutical and Biotech Regulatory Information Management event.

This is running from the 22nd - 23rd March 2011 in London. Now for anybody that’s interested in attending, what would you say Neil, will be the key learning points from your presentation at this event?

N Gow: The presentation, if it goes ahead, will be coming back to that compliance issue which I think I already said was worthy of topic on its own. It’s a bridge-head really between the legal compliance which I think you have at the conference and the EDMS and regulatory publishing part of it, and it’s around this issue of how do we get business compliance? How do we get the users buying in and using the system?

The other topic that matters to me, is how we actually manage documents that aren’t in the scope of the system or any other system that we have. So it’s really all about how you’re going to make it work in practice, because it’s all very well to have a system. But if people don’t like it very much, to have rules and regulations about compliance, people don’t always stick to them; and it’s actually a question of: what do you do to make it work in practice?

Pharma IQ: Yes, absolutely. Well, thank you very much Neil for your time today, it’s been great to get your point of view on some of these key issues. Thank you very much.

N Gow: Thank you.

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