REGULATORY

Managing your regulatory information: address challenges and achieve success

Jim Nichols, Liquents, a Thomson Scientific Business

As French intellectual, novelist, essayist and critic Marcel Proust, best known as the author of In Search of Lost Time, has said: “The real voyage of discovery consists not in seeking new landscapes but in having new eyes."

Life sciences companies around the world are finding “new eyes” in response to evolving and emerging regulatory requirements. As these companies start on these new voyages, new opportunities for operational excellence are appearing within their regulatory affairs areas. What new concepts have these companies identified that are leading to new ways of working? There are many. The following article describes only a few of the key areas that these companies have explored and implemented.

Identifying information already distributed

Companies are looking for reduced efforts in preparing and reviewing content for regulatory submissions and updates because official document versions can be identified with confidence and reused without extensive review cycles.

Typically in a electronic document management system (DMS) environment, it’s easy to identify which documents are internally approved. However, it’s not easy to identify which are externally approved for a given market. Even when the relationship of the submission to the source component is tracked, it remains difficult to know if a particular component, once submitted to an authority, was ever approved, or if that component was ever made obsolete by the submittal of a replacement. As a result, authors often recreate content or reuse content that is the wrong starting point for a particular region. Because of this current risk in the DMS environment, extra review and approval cycles may need to be provided, wasting time and efficiency.

There is also a bigger risk that incorrect manufacturing information, for example, is provided to an authority, which can delay drug approval dates. These companies will look for ways to help authors and publishers find and verify the correct document components by connecting the submission and registration management function with the DMS. This provides the author with access to information on the document components that are considered “current” for a particular country. Examples include the following:

• For any document in the DMS, the ability to see where the document was submitted, approved and if that approval is still current. If not still current, the ability to see what document replaced it.
• For a given country, the ability to see all in-effect submitted and currently approved source document versions.
• The ability to query to find a specific kind of document that is approved for a specific country as of a specific date (for example, “show me the approved stability document for France”).

Typically the efficiency savings associated with finding the desired document to start authoring from are two to three hours per document, and there are five-100 updated documents in a variation. In general time duration delays of added content reviews, fact verification, or rewrite of content are two to four months for a submission or update.

Keeping track of product details

Companies want to reduce resource effort when identifying the regulatory impact of manufacturing and labeling changes and responding to agency inquiries, while also decreasing compliance risk and improving safety by ensuring registered product details are accessible interdepartmentally and globally.

Companies will seek solutions for the tracking of registered product details such as shelf life, indications, and manufacturers, that also provide targeted reporting to evaluate which products, markets and registrations are affected by a proposed change – such as a change in supplier. These investigation requests can occur dozens to hundreds of times within a year for an active product.

Moreover, when these solutions can be made available via a web client, companies can also encourage a more proactive approach to the verification of operational data. By leveraging good design practices, focusing on end-user training and holistically implementing their approach, a product detail management solution can be associated with a two week reduction in research effort for each request.

Incorporate submission planning and tracking

Companies must have reduced efforts when preparing and reviewing dossiers.

By enabling increased automation in the creation of the regulatory submissions, the result is less user time spent on repetitive manual activities such as adding folders and assigning files and more time available to focus on quality and management activities. In addition, because the document assignment process itself is more automated, based on standard approaches, users are less likely to make errors in document assignment to the submission. These errors result in increased cycle time during internal review, or even potentially a longer agency review period.

Capabilities to enable more efficient dossier assembly can include initiating a new collection using a cumulative or virtual view of what has already been submitted in another region. For example, the Australian filing could be based on the European filing after many updates were applied to the original submission. Rather than requiring the user to manually determine and replicate this need, start with a virtual submitted or approved view to be the basis for the new submission structure. As compared to starting a submission from scratch, this can save 10 days in assembly time and potentially up to 25 days in research and compilation time.

Integrated submission and registration planning and tracking

Companies can accelerate drug approval timelines and registration support activities, requiring fewer resources via improved coordination, planning and tracking while also reducing the effort required to research and report on submission status. Ultimately, operational efficiencies can be gained by ensuring that the key functional areas and their associated information management needs are supported in an integrated fashion. In doing so, these companies can support executive summary reporting to manage risk in completing dossiers on time and identify remaining components for the submission which are complete and ready for review and approval. In companies where this information and the related processes are not truly integrated, the typical methods of manual submission reporting are associated with one day per week for a submission over a threemonth duration.

Management techniques for communication of document due dates and identification of late documents may be associated with two to three weeks reduction in duration for a submission. Companies can improve co-ordination of submission tasks, global communication, and resource management by providing a central portal to all product activity, product milestones, interdepartmental tasks, and best practice documents.

Poorly understood milestones and non-coordinated activities can cost months in unnecessary resource expenditure submission activity. An example is two global regulatory groups producing the same or conflicting submission requests. Poorly managed resources can result in weeks or months of staff supplementation consulting needs. By comparison, well-co-ordinated communication with affiliates, partners, and regulatory groups typically reduce preparation of product changes by one-four months. For most life sciences companies, the information available to their regulatory affairs areas is likely to be sparse and managed across a host of disparate applications and locations. For the companies who have faced this challenge by seeking an approach that integrates much of the information by providing systems to several different functional areas, new benefits are being realised.

These benefits include:

• Reduced costs by achieving operational efficiencies. These companies are realising the value of entering information once and using it many times since they are moving away from having different functional areas entering the same information repeatedly. They are also finding that by consolidating multiple point-solution systems, they have a lower IT burden for maintenance and validation activities.
• Strengthened partner communication and collaboration capabilities have yielded better working relationships with internal and external affiliates and across their global locations.
• Improved speed and accuracy of decision-making has resulted from the ability for these companies to locate, aggregate and analyse key information leading to the potential avoidance of missed business opportunities.
• Increased abilities for their organisation’s compliance since they can now quickly and completely deliver information that enables manufacturing and labeling compliance and also stay on track with product registration renewals and mandatory reporting requirements.

What do these companies all have in common? Essentially, they have realised that by “connecting the dots” that represent what have historically been isolated data points, they can achieve new successes in their operations and excel at what is now being called “regulatory information management”.

Jim Nichols

Jim Nichols is Vice President of Product Strategy & Marketing at Liquent, a Thomson Scientific Business.

Thomsom Scientific
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Tel: +44 (0)20 7433 4000
E-mail: ts.pharm@thomson.com
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