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Closer Encounters: How the Changing Regulatory Environment Is Connecting Regulatory and Safety


The move towards centralizaton and harmonization means that the regulatoy and pharamcovigilance functions can longer work independently, writes Markus Dehnhardt, Ph.D.

The move towards centralization and harmonization means that the regulatory and pharmacovigilance functions can no longer work independently, writes Markus Dehnhardt, Ph.D.

For the past several years, regulatory authorities have been striving to create more centralized and more harmonized processes around all regulated activities. As a result, life sciences companies have had to reconsider (1) how they manage the information related to all of the activities involved in meeting regulatory authorities’ requirements and (2) how the various functions that are performed in providing information for the regulators can be carried out more efficiently.

Most crucially, the shifting landscape means that the regulatory and pharmacovigilance (PV) functions can no longer work independently, as they have in the past. Both functions are affected by today’s rapid expansion of product data, by PV’s responsibility for reporting regulated data, and by the use of that data in PV documents. During inspections, for example, the authorities are increasingly looking for data outside pharmacovigilance, and in particular, they’re paying closer attention to data in regulatory. Thus, the lines delineating the two departments are becoming increasingly blurred.

The mingling of the two functions has become more apparent with the advents of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and the Identification of Medicinal Products (IDMP). The European Medicines Agency has a clear goal-to manage all aspects in PV in relation to XEVMPD reported information, which would seem to extend to regulatory for IDMP data in the future. As a result, the lion’s share of information will be derived from the dossier, which has to be available electronically-and in accordance with the required structure when it is known-together with recent product information and variations and product launch dates.

Interviews with several regulatory and pharmacovigilance experts at various pharmaceutical companies offer enlightening views on where the industry is headed with regard to managing those growing intersections.

Driving Forces

Numerous activities bring the two groups of PV and regulatory more closely together-for example, maintenance of a company’s product dictionary electronic submissions, certain annexes for the company’s risk management plan, aspects of the company’s Periodic Safety Update Reports, and, most notably in the future, the Identification of Medicinal Products. Furthermore, sharing information and having a better understanding of other departments’ functions can only benefit the business.

Equally from a commercial point of view, companies are gaining growing awareness of the need for greater collaboration amid functional overlaps and shifting responsibilities. For example, a unified approach to the way regulatory and pharmacovigilance prepare a submission or a product launch could help a company respond more efficiently to country-specific requests. Some experienced regulatory and pharmacovigilance leaders have gone so far as to say that having guidelines that require the two departments to work together more closely is good for business because such guidelines and such collaboration lead to improved productivity.

How are companies responding to the changing dynamics? Discussions with various regulatory and pharmacovigilance leaders demonstrate that even though approaches may differ according to the individual needs and the size of a company, there is growing recognition of the need for business units to work together.

Uniting Functions

Many of the roles and activities handled by regulatory and pharmacovigilance have extensive and continuous overlaps, and therefore closer collaboration and stricter consistency in managing data and procedures are vital. Recognising that reality, more and more companies are starting to put PV and regulatory within the same reporting function. For example, Grünenthal has adapted processes that facilitate the sharing of information across departments, with regulatory checking all actions undertaken for safety reasons and with pharmacovigilance ensuring regulatory gets informed about any data that could trigger, say, a label change. Members of product-specific teams from both functions meet regularly to exchange important information.

At Basilea Pharmaceutica International, both regulatory and PV are parts of the clinical development management team, working closely together at the product level and interacting frequently.

Klaudija Marijanović Barać, MD, DPM, director and global risk management group leader at Teva, says that Teva’s two departments worked together to create joint standard operating procedures and processes and that the groups continue meeting regularly to improve processes. For example, the company’s risk management plan is owned by pharmacovigilance, but it’s up to regulatory affairs to communicate with the authorities in order to fulfil regulatory obligations adequately, Teva’s PV team needs to work with regulatory affairs so as to ensure good procedures or working instructions are in place and being followed.

The aforementioned are certainly bold and progressive steps towards full collaboration, but Anne-Cecile Laborie, PharmD, director of global regulatory affairs resources, tools, and processes at Ipsen Pharma, says more needs to be done to ensure a common way of working, adding that collaboration on a topic-by-topic basis implies working only in parallel rather than in the desired, unified way.

But unity in all aspects of PV and regulatory might be impractical at some organisations, and Rudi Scheerlinck, MD, head of global drug safety at Basilea Pharmaceutica, suggests the collaborative process between the two groups must be tailored to an organisation’s. One way to improve cross-functional insights at big pharma, he suggests, might be to offer secondment or job rotations whereby PV and regulatory gain better understandings of each other and can then use the arrangement to the advantage of the organisation.

However companies choose to manage the intersections, the fact is that PV can report only what regulatory affairs has maintained in the EudraVigilance database; and ensuring that that database is correct and up-to-date underscores the need for collaboration and for clearly defined roles and responsibilities. Experience shows, though, that it’s not just about meeting more frequently or coming to an understanding of one another’s roles. A centralised approach to the way information gets stored and managed is just as important. Chantal Bernardeau-Coeuru, project leader of information technology regulatory solutions at Pierre Fabre Laboratories, warns that separate databases used by regulatory and pharmacovigilance for product information will result in information that gets recorded differently. It’s a view also held by many of those who are experienced and therefore familiar with the vagaries of separate processes and systems. As Dr. Laborie says, it doesn’t make sense to have information in one database and copy it to another, because inevitably, one or both will become incorrect.

A strategic approach to regulatory information management (RIM) is, arguably, the most effective way to achieve data consistency. The strategic approach is also the goal of a large number of pharma companies. In its 2014 industry survey entitled Next Generation Regulatory Information Management and Intelligence: Strategy, Investments, and Status, Gens & Associates finds growing interest in leveraging processes and systems across divisions. Asked to describe their RIM strategies, 40% of surveyed companies define them as comprehensive RIM strategies that include other functions and key third-party partners. A majority of surveyed companies (70%) understand that pharmacovigilance should be an integral part of any RIM strategy, and as such, either they are in the process of improving their RIM capabilities around safety reporting or they plan to make such improvements in the next two years.

A comprehensive and strategic RIM approach has the potential to be the glue that binds all R&D information-regulatory, safety, clinical, manufacturing, and marketing-and that frees relevant data to be used by all stakeholders as and when needed.

Confronting Change

As the regulatory authorities continue requiring more and more information, continue collaborating with other authorities more frequently, and continue deepening their communications with companies, it is even more important that pharma companies implement rigorous communication procedures.

One of the biggest hurdles to building stronger intersections is to make sure that messages and information from stakeholders such as authorities or affiliates get passed on accurately and in full. Experience shows that it’s about good teamwork: building teams that are accustomed to working together so that each knows what to expect. For example, regulators increasingly send companies unplanned requests-in other words, communications that are unexpected by companies. For his company’s part, Rüdiger Faust, PhD, head of regulatory intelligence and regulatory operations, global regulatory affairs, says Grünenthal prepares to manage such requests by (1) capturing the information, (2) ensuring it gets communicated to safety-and especially to the qualified person for pharmacovigilance-and (3) tracking it to see to it that the company has provided a response for the authorities. He adds that such a procedure has become standard practice in the industry.

It’s arguable that departmental priorities could present challenges to cohesion because inevitably, each department will be focused on achieving its own objectives first and foremost. But as long as robust discussions are held to determine roles and define ownership, collaborative management of activities should not be jeopardised. It’s also important to gain an understanding of what colleagues in other departments require to get their jobs done; having such insight makes it easier to determine what processes need to be established, what information needs to be provided, and what the flow of information flow will be.

The way a company manages its intersections and collaborations will depend very much on the size of the organisation, but the same principles apply in all instances. Dr. Scheerlinck describes those principles as ongoing discussions about the best options in given circumstances and the adoption of tailored approaches that are workable and include clearly defined owners for the different tasks. He emphasises the need for all parties to take time to sit together, to really communicate by each party’s explaining what it needs, and then to work out how to best meet those needs.

Goodwill, openness, honesty, and willingness to collaborate are the critical ingredients to building strong interdepartmental links. Integral to success-particularly for departments accustomed to working separately-is the selection of a bridge builder, Dr. Faust suggests, adding that it’s important to have key people in place to bridge divides, communicate across departmental silos, and act as role models by generating collaborative ideas and actually living the cooperation.

Ideally, the goal of interdepartmental collaboration should extend beyond regulatory and PV to include clinical, development, manufacturing, and marketing. As Ms. Bernardeau-Coeuru points out, whereas the documents belong mostly to regulatory, many functions have to provide regulatory with information for those documents, and so, working together more closely is important.

An End Goal

The need to find common ways of working that cut across departments and a more centralised way of managing activities that cuts across departments will become all the more critical with the advent of the IDMP. Companies therefore need to formulate plans not only to meet regulatory requirements but also to enhance the business through the integration of infrastructures and processes.

Ultimately, closer collaboration and improvement in the ways information gets managed and shared benefit the broader organisation by ensuring regulatory requirements are met, by seeing to it that regulators’ questions can be answered quickly and efficiently, and by helping drive informed decision making across the portfolio.

About the author 

Markus Dehnhardt Ph.D. (mdehnhardt@productlife-group.com) is a senior toxicology and pharmacovigilance consultant at ProductLife Group ( www.productlifegroup.com )



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