Table 2.

Excerpts extracted from the interviews and coded as part of the best practices theme

Interview	Stakeholder group	Excerpt	Code
SI08	Patient representative	We have to educate the people; a lot of training is needed, so we have our own programs for patients to understand pharmacovigilance. We have to increase awareness of how the PV works and how patients can report, and that is why we participate in the European Awareness Week on PV and patient reporting, and I think we have to amplify this communication	Patient Education and Empowerment
SI12	Neutral party	Now we see that patients who actually completed the EUPATI program have a foundation of knowledge that completely steps up their game in terms of the advice given, their understanding, and their contributions to the discussions; their general contributions to the system are huge	Patient Education and Empowerment
SI13	Patient representative	Offer information, especially training in different areas like medicines, regulatory and approval processes of drugs and how they follow them up, so that when the patient has the opportunity to participate, they have a good level of base knowledge of the topics in the discussion	Patient Education and Empowerment
SI19	Marketing authorization holder	When patients are well informed, they make good decisions, and I would say that the more educated, the better	Patient Education and Empowerment
SI04	Regulator	Every activity we have done, we have tested with patients; the Patient and Consumer Working Party (PCWP is instrumental in things like the public hearings. They were working with us when we designed how we would do it, how long they would be, how long each speaker would have, how we should lay down the audience, everything we did with them, everything we have done, we have always done it by consulting with the patients	Engagement from the Start-Design
SI11	Regulator	We have 2 years of doing these patient seminars with the patient organizations; we have a program or a group with representatives from the patient organization with whom we sit down and consider what kind of agenda, what kind of topics would they like to hear about; we have a full day of speakers, and they can come with their issues	Engagement from the Start-Design
SI17	Marketing authorization holder	It is important to have a long-term partnership so that when you are talking about real collaboration, real partnership and long-term, it is really not at the end and you just say "is this ok for you or not?" but rather having the people involved from the start	Engagement from the Start-Design
SI01	Patient representative	There should be laws, there should be policies, there should be practice guidelines, there should be standards showing how these patients should be involved in the regulatory and pharmacovigilance system and how they relate to other stakeholders, almost like a framework like the one WHO has, so that everyone is clear about what is expected from them, what are their obligations, what are their rights	Structured Involvement and Guidelines
SI04	Marketing authorization holder	I think is important moving forward now to have this guidance like the one that the FDA has, like global guidance on patient engagement, how to involve patients throughout the whole life cycle of the medicine	Structured Involvement and Guidelines
SI12	Neutral party	There were initiatives like, for example, PARADIGM* and others that really gave a structured identity and structured way of involving patients, how can it be done and the conditions to do it. That really encourages organizations to do it more proactively	Structured Involvement and Guidelines
SI03	Regulator	What we are currently doing is complementing the generic framework, because that framework is for any kind of engagement we have in relation to medicine, but for pharmacovigilance we don't have a specific one, so we want to complement what we have with a document on points to consider, and that would be tailored to specific risk scenarios, to see how we can engage in those	Structured Involvement and Guidelines
SI04	Marketing authorization holder	They have this valuable information that is needed to do a proper follow-up for any medicine that is on the market, so I think things have changed over the years, and it is not just that patients should just be passive acceptors of medicine and treatments, but they have now evolved to be collaborators with us	Patients as Same-Level Partners
SI06	Patient representative	My dream is that patients are just one of the stakeholders, they are viewed as just one of the stakeholders, so you have the pharmaceutical companies for the development of new medicines, regulatory agencies for regulation, but in that list you also have the patients in the same position, and they are really seen as one of them. For now, I think it is not the case; we have to fight for the position of the patients, and in the future I hope that will not be necessary anymore	Patients as Same-Level Partners
SI03	Regulator	The role of the patient has changed over the years and is no longer just the person with an illness that receives treatment from a sort of higher authority from the medical system; it is increasingly becoming and has been defined as a partnership and shared decision-making	Patients as Same-Level Partners
SI12	Neutral party	Real-time interactions like a meeting are a sign of respect somehow, because otherwise, with a survey, it might look a little bit more transactional, and you can have written feedback afterward, of course, to use it in your research, but I think if you really want to partner with patients, it is more important to have a meeting	Face-to-Face Communication
SI10	Patient representative	There is just something to be said for face-to-face interaction; it is the most powerful, it is a force of nature, you must listen to me while I am speaking. An email, an online platform, you can ignore it, but with face-to-face interaction, you can't, so nothing beats it	Face-to-Face Communication
SI13	Patient representative	I have always thought that having someone there whom you can ask a question face-to-face, either by videocall or a physical channel, and seeing someone there at the other side makes communication easier, gives you trust and the security to know who is answering you	Face-to-Face Communication
SI06	Patient representative	I would like to know what is going to be done with my feedback email, or when they have had many emails, they say "Okay, we are going to talk about it, and in about a month we will give you back feedback from us, and we can give you the negative points and the positive points and what can we do better in the future," which would trigger me to send another email in the future	Full Circle of Feedback
SI07	Patient representative	Sometimes we just hear people and don't hear the results of their hearings or meetings, and so people afterward feel they weren't heard; they never know exactly what was done with their opinions and with their work, so it is really important to have the full circle of patient involvement in the process, to give them the full feedback	Full Circle of Feedback
SI08	Patient representative	I think that probably the best way that pharmacovigilance could progress is when regulators and patient organizations, for example, have some research questions and work together on how to respond to those questions. I think that the ultimate goal of pharmacovigilance and patient engagement would be direct-to-patient PV, that whenever a questions arises, we join together and discuss how we can respond to those questions	Establishing Common Goals
SI14	Regulator	That your goal and the goals of the patients are aligned or clear between both of those parties, and they can be accomplished together so that it is meaningful and impactful and can have value for patients and public health	Establishing Common Goals
SI05	Patient representative	In one of the committees I work with, there is really an equilibrium, and we discuss what is going wrong, and they accept a lot. And in the other group, there are a lot of doctors, and I am the only patient … and they have real difficulties accepting the opinion of a patient; they are too far away from the patients, and I am sitting there and playing my role a little bit to see that they don't make something that is impossible for patients, but I don't bring a lot of news because I don't feel good in this group	Developing Trust and Balance
SI14	Regulator	In my role, I would pretty much be keeping in touch and building those relationships over time, and it does take a while to foster that change and for them to feel comfortable, to have that free interaction, I guess, because the patients and the organization need to feel that	Developing Trust and Balance
SI10	Patient representative	It is intimidating to see someone on the other side, because all of you look like doctors and politicians in our eyes, and patients get intimidated or scared, maybe, not to say what you guys want to hear	Developing Trust and Balance

PV pharmacovigilance