What next for PIM and Lifecycle Management?

Helen Winsor

Dr. Andrew Marr, Director of the e-Regulatory Development and Global Regulatory Operations, and Co-Chair of the PIM Steering Committee on behalf of the EFPIA, joins Helen Winsor from Pharma IQ, to discuss the latest developments in PIM for Lifecycle Management. To listen to the podcast now go to:A Regulatory Perspective: Integrating PIM into the Product Lifecycle:

Pharma IQ:
Welcome to the show Andrew, how are you today?

A Marr: I’m fine, thank you Helen.

Pharma IQ: I’m glad that you could join us. To start off with I’d like to ask, in summary, what are the latest developments in Product Information Management, or PIM as it’s known?

A Marr: About nine months, 10 months ago, the European Medicines Agency (EMA) issued a Statement of Intent around switching the way that it manages product information from the Word-based process it operates now to a PIM-based process, which uses things like XML.Since then, the timelines have slipped slightly. We are waiting for EMA to re-issue its Statement of Intent, but what it needs to wait upon is the firm date for the revised version of the PIM review system, which is the tool it uses to do the evaluation of the PIM files that we submit. Once it gets a firm date for that, then this Statement of Intent will be re-issued. We hope that will be very soon and then that will confirm once and for all the timelines that we would need to work to.

Pharma IQ: Secondly, why is it important to prepare before implementing PIM and what would you say are the main challenges faced?

A Marr: PIM has been in development for some time, and with EMA stating that it will adopt this as the standard way of working, all applicants who have either got approved product information, or ones who are going to be submitting product information with their new applications will need to take account of PIM. Since this is the way that EMA wants to work, the direction that it’s stated, it’s something that will happen and the question-mark is only around precisely when that will happen. The product information that we have now will need to change and really take that forward in the implementation. Applicants are going to have to understand what PIM is, how it will change their product information processes, technology support, that will be required and services that might need to be bought in to be able to manage this product information.

The key basic driver for some of this is around the way that information is consumed bothwithin the regulatory agencies and also with the public. The way that we have produced our product information to date is not exactly great for the reuse of that information in the way that it is presented in systems and to the public. It’s designed in an old way of page-based information rather than in a much more modern way, in being able to read that on the internet and do all sorts of searches and comparisons, etc. It’s going to change the way that we do things and change them fairly significantly, but ultimately, change them for the better. But as a change process, we really need to pay attention to how to do that.

Pharma IQ: Andrew, can you give some examples of lessons learned so far in implementation?

A Marr:
PIM is a pilot programme at the moment. There have been five or six companies taking part in it and there are seven or eight products that have gone through it. And as with any pilot, the idea is to identify business issues, technology issues. Consequently, we expect there to be problems along the way and to be able to accommodate those with workarounds and further development, etc. So it’s certainly been a challenge to the companies that have been involved in these pilot implementations.

So, lessons learned. The way in which the guidance is written can be confusing and so we need to improve that. The way that the applicants have used the tools in implementing something may not be what the agency is expecting, and so there have been some technical issues there that we’ve needed to further develop the data exchange standard for. There have been a number of business process issues. In essence, people still need to talk to each other, but because they’re now using a system, in many instances they believe the system will do everything for them and they don’t need to inform the next person down the line that something has happened. But this isn’t the case. We’ve certainly learned a lot about the process and the technology, and these are all being addressed. We believe that as we come out of the pilot and into production, the whole process will be a lot more efficient.

Pharma IQ: And what are the key advantages to be gained from implementing PIM?

A Marr: You can balance this in two ways. One is that EMA is effectively really requiring this to be done. It can’t mandate it because there is no legal basis for this. But if it streamlines its processes to make use of this and make use of the delivery of the information, then it really does drive the applicants to utilise PIM. If the information is going to have to be migrated, if you are continuing to do it in Word each time and then it subsequently needs to be checked, etc, then not using PIM can be a very inefficient process. So, that’s one driver, it’s saying it’s effectively mandatory.

Let’s look at it and say: ‘why is it being done?’ There’s a whole series of things here. One is quality. If you look at your product information now, particularly if you have got more than one SPC or more than one set of patient information leaflets, then I would guarantee that there will be errors between these particular documents, simply because they’ve been edited so many times over years that they’ve drifted apart. Where text was aimed to be the same, there will be some differences between those, not just in the English-to-English, but also the way that things have been translated from English to other languages.

Every product that’s been looked at has got a whole series of consistency issues associated with it, perhaps lack of compliance with the QRD (Quality Review of Documents) template. In Word, it’s perfectly feasible to manipulate the product information and change it from what should be standard statements to things that are non-standard. In most instances, the process would catch those and they would have to be changed back, but in some instances they slip through and they’re not spotted. So there are standard statements that should be standard that aren’t standard, as an example. And so when we’re doing the product information creation in PIM, there is a great chance to reuse information.

So instead of effectively having the same piece of information in multiple documents, you manage that piece of information once. You keep that up-to-date, you keep that correct, you use that piece for translation so that everywhere that that piece should appear you can guarantee that it’s the same piece of information. Create, manage and approve a piece of information once and then reuse that many times. And then, in terms of availability of information to the public and to patients, the way that EMA publishes its information at the moment is a single pdf file, one per language. That is, in some instances, not a great deal of use to a patient. There are examples of documents that are over 180 pages long and, really, it’s not consumable. You can’t easily search across products; you can’t do comparisons within particular documents very easily without significant software tools.

And so what EMA wants to do ultimately when it’s got this set of information in PIM is to
be able to publish in an improved way on the internet, and also to provide that information internally in a much more consumable manner. The nature of the output will change and it will be a much richer source of information to do a variety of things with. In terms of the key advantages, these will differ as to whether they’re perceived to be what the advantages to the regulators are, what the advantages to the applicant is and also what the advantage is to the consumer who uses the information, the public, patients and medical profession, etc. It’s a new way of delivering information which will have new ways of being consumed.

Pharma IQ: Sure. Finally, to round off, Andrew, I understand that you’ll be presenting at the upcoming conference, Successful eCTD Lifecycle Management, which will be taking place from 13th - 15th September. For anybody interested in attending this event, what would you say is the key learning point that can be gained from your presentation?

A Marr: I think there are a number of things here, certainly the current status of the programme. EMA may, by that time, have issued its Statement of Intent, and we can certainly concentrate on the detail of that. If it hasn’t, then I will be providing the unofficial position on that. We can look at the challenges that there are in migrating to PIM, but also the opportunities, understanding why it’s being done. We can look at the plans that an applicant would need to have in place to begin to use PIM, and what some of the possible approaches are in terms of software or service provision to do these things. I think it will give people a good overview of where the project is and what they need to do to get ready for it. Then others can follow on with more detail about the technical and labelling aspects of the migration to PIM.

Pharma IQ: What do you personally expect to gain from the conference?

A Marr: What I expect to gain is interaction with the audience. I think it gives people theopportunity to ask questions and to keep up to date with information. There’s nothing worse for a speaker than to have a silent audience. We’ll have some eminent speakers at the conference, not just on PIM but also on other aspects of the eCTD. I really do expect attendees to make use of the facility. It’s not just about soaking up the information one way. It’s really useful to hear comments from the audience because these are the frequently asked questions that we really should be addressing in terms of the communications that the EMA puts out, information on websites, etc. We need to hear what questions people have so that we can more routinely address those. Two-way communication.

Pharma IQ: Let’s hope that the event provokes a good debate. Andrew, thank you so much for your time today. We really do look forward to your presentation.

A Marr: Thanks Helen, and I hope to see lots of people at the conference.

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