Aptus.AI’s Compliance Talks, episode 2: interview with Simona Scialpi
The second episode of our Compliance Talks features Simona Scialpi, Head of Legal & Compliance at Daiichi Sankyo Italy. Even turning from the financial sector to the pharmaceutical one, the need to transform compliance into a proactive function that can generate competitive advantages has proved to be very strong. Here, then, is another snapshot, from one of the Italian top experts, of the state of the art, critical issues and prospects for technological innovation in the field of compliance.
Simona, tell us more about who you are and what you do for your company.
“I have been working in the pharmaceutical sector since 2009. My first roles were in the areas of Audit, Risk Management and Financial Compliance, and then later moved into the world of Ethics & Compliance, an area in which I still work at Daiichi Sankyo Italia, a Japanese pharmaceutical company active in the cardiovascular and oncological fields. My work and that of my team consists mainly of supporting my colleagues in the management of various business projects. To do this, we both provide a set of internal policies that define the guidelines for managing the various processes that are sensitive from a Legal & Compliance point of view, but also work alongside our colleagues on a daily basis during the various stages of the projects, so that they are implemented in compliance with the industry regulations “.
What do you enjoy most about your job and what do you find most difficult?
“Working in the pharmaceutical sector, one of the best things is to think about the ultimate impact of my work on patients: the idea of being able to make even a small contribution to improving their living conditions is a note of pride for me. With regard to my role in the Legal & Compliance area, I strongly believe that compliance should not be seen as a mere approval function: I like to conceive it as a support function that, as such, works alongside the business functions right from the brainstorming stages because, only in this way, is it possible to achieve common goals “the right way”. Thinking about the difficulties, these latter are present mostly in the management of complex and multi-stakeholder activities, when it is indeed difficult to bring different functions together and to combine the objectives of all, while always ensuring compliance with the relevant laws and regulations. This complexity, however, represents a challenge that makes my work continuously stimulating”.
What are the main skills a Compliance Specialist must have in your opinion?
“From a hard skills point of view, a good Compliance Specialist must combine a legal and economic background to what is called a “ Business Acumen”, which enables an understanding of business objectives in order to provide the most effective support possible. From a soft skills point of view, curiosity and the desire to be constantly updated are decisive, because they are in fact also a necessity. Just as relevant are the relational aspect and knowing how to work in a team: as already mentioned, the compliance function must not intervene at the end of the process to provide any green light to a business, but must work together with the business from the earliest stages, with an approach aimed at co-creation. In short, a good Compliance Specialist combines hard legal-regulatory skills, business knowledge, excellent interpersonal skills and team spirit”.
What is the main problem or limitation in the area of compliance?
“Certainly, one problem of the compliance area is its being perceived as a hostile function. Therefore, from the point of view of internal perception, it is very important to create a culture both on the role of compliance and how it can represent a competitive advantage for the company, but also on the role of enabler that the compliance function can have. And for this, teamwork is crucial, since all functions, through their cooperation, contribute to the achievement of the company’s objectives”.
Do you think there are sufficient resources dedicated to compliance in Italy?
“I can speak about the pharmaceutical sector, where I have been working for years in large multinationals — and where I have contacts with colleagues who work in other realities: I can not say whether the resources allocated to compliance functions are sufficient but, certainly, being a very regulated sector, there is a great sensitivity to compliance structures, because one understands their value. What I have learnt from my experience is that support functions must grow in proportion to how much the business grows, to ensure the necessary support”.
In which steps of compliance processes would you most need the support of innovative solutions?
“In my opinion, there is not one phase more complex than the other in the compliance process, but each phase responds to a life cycle with its own complexity to be managed. Especially in a highly regulated sector such as pharmaceuticals, great care is needed from the earliest stages of projects, because the impacts can be different — legal, privacy, reputation -: a careful mapping of the needs and risks that a solution or project may entail is therefore vital. Even with respect to a possible automation of processes, every phase is good for capturing insights for improvement. Certainly, a tool that transversally offers a continuous regulatory update could be a valuable ally: there are projects that last a long time, so the relevant regulations could change in the course of time. Having a tool that always provides the latest regulatory updates would be useful to promptly reprioritize Risk Management activities and always have an updated and monitored risk mapping. In project management, this applies to both the design and execution phases”.
Do you currently use technology tools to support your work?
“Today we use (non-automated, ed) alerting tools mainly based on newsletters to stay up-to-date. We then have internal tools for approval flows and internal policy management. However, if we talk about automated regulatory updates, I am not aware of any similar tools in the industry at the moment”.
If you had a magic wand, what tool would you create to support your work?
“Surely being able to automate the aspect of regulatory updates and the consequent impact on business management and related risks is the fundamental and most critical one, since the analysis of case law takes time. Reporting systems that bring together different data, for the purpose of careful and cotinuos risk management, would also be very useful. Very often we work on different systems, so having dashboards that aggregate sensitive data by providing KPIs would be very useful”.
Turning to current issues and focusing on compliance in your industry, how has the Covid-19 pandemic impacted the pharmaceutical regulatory environment?
“In my opinion, in the pharmaceutical field, the pandemic has been an accelerator on certain aspects, especially relating to interaction. Several industry activities historically based on physical interaction were no longer possible with the pandemic. This led to the development of various activities based on digital interaction (like conferences or telemedicine platforms), which led companies and industry associations to reflect on how to apply existing rules and regulations in the light of the new requirements. My take home message from this situation is that industry needs and regulation must go hand in hand — and this I believe applies not only to the pharmaceutical sector, but also to the financial sector on which you are focusing at the moment. And this alignment is also important with regard to the “regulation-innovation” pairing. I am thinking, for example, of the provisional restriction order issued by the Italian Garante della Privacy for ChatGPT, which called for the concrete implementation of a series of measures and prescriptions to guarantee the protection of personal data. So, I welcome innovation, when it can lead to the optimization and streamlining of processes, while at the same time taking into account all the requirements in force, so that these tools are real opportunities”.
Originally published at https://www.aptus.ai.
