HURAS discusses challenges and common goals

The 10 Minute Interview: Ilia Slavov, President of HURAS in dialogue with Lynda Wight, Executive Director of TOPRA

The Hungarian Regulatory Affairs Society (HURAS) has helped to add the valuable ‘local dimension’ to the planning of the 5th Annual TOPRA Symposium. In the first of the ‘TOPRA 10 Minute Interviews’, Lynda Wight asks HURAS’s president, Ilia Slavov his views on regulatory affairs in Eastern Europe, working with TOPRA and what he values in regulatory affairs education.

LW: What is your most outstanding accomplishment in the last 12 months?

IS: One of my outstanding accomplishments in 2008 - which I am very proud about - is that I was re-elected for the 5th time by the General Assembly of HURAS (Hungarian Regulatory Affairs Society) to lead this very professional organisation for the next 2 years. From the professional point of view, I think that this is an outstanding result in my life as more than 200 Hungarian regulatory members fully supported my function and shared with me our common vision; namely for HURAS to become a leading society for professionals involved in all areas of regulatory affairs and therefore to become a leading provider of high quality education and training.

LW: What is the unique perspective of Central and Eastern Europe in the world of regulatory affairs?

IS: The Eastern European countries are new members of the European Union – most of them joined the EU in 2004 and the latest two, Bulgaria and Romania, in 2007. Prior to the EU accession, all regulatory regulations, requirements, law and registration procedures were local ones and therefore, in several cases, different from centralised procedures. For almost all countries, the regulatory environment was difficult to manage from both sides (authorities and pharma industry), challenging and not harmonised. Working in this challenging and changing Eastern European environment improved the communication management and skills of our regulatory professionals.

LW: And do you think that in this short space of time there has been progress in this area?

IS: Yes, a lot of industry RA professionals have built unique relationships with the national regulators - and bear in mind that local regulatory professionals are the best local experts in a respective member state. They have specific knowledge, expertise and experience in a local environment and regulations. In general, our regulatory professionals are more flexible, their toleration threshold is considerably higher than that of our colleagues in "old" Europe and their problem solving capabilities are also unique.

LW: I would like to press you a bit more on that. For instance, do you think that there are particular challenges faced by professionals in Eastern Europe that are not shared by their Western European counterparts?

IS: The greatest challenge is that we joined the already operating European drug regulatory systems later. Thus from 2004, we had to study the new regulatory processes that had already been implemented and widely used within the rest of Europe. We had to start upgrading the documentation for all products registered in the member states within a very short timeframe. To this date, it requires a lot of effort from us as the locally approved registration documentation's of the related products may differ considerably from those approved within the EU. Additionally, the economies of the newly accessing countries are not as developed as those of the old member states of Western Europe, but we are expected to reach the same level by using very limited resources. Another particular challenge stems from the approaches of agency and industrial professionals towards the administration of regulatory tasks. As I said before, a lack of or wholly inadequate communication between agency and industry was characteristic to the Eastern European region prior to EU accession— instead of entering into dialogue, we normally just got instructions and orders. This is an area where more should be done— a proactive way of thinking needs to be developed for individuals within our region to break out of old patterns and to teach people to rely upon their own skills instead of waiting for the state or other authorities to solve all problems for them.

LW: It’s interesting you should say that. What are the best ways to facilitate dialogue between industry professionals and their counterparts in the agencies?

IS: The best way to facilitate dialogue between industry professionals and MS regulators is the foundation and operation of an association like HURAS in Hungary. In our training programs, we emphasise the importance of continuous dialogues with the respective local authorities, the heads of which have conducted lectures in our conferences several times. We were fortunate as since the foundation of our association, the former General Director and management of the National Institute of Pharmacy (NIP) support the activities of our association as an acknowledgment of our efforts and the opportunities that we can provide. In this year, we are already organizing the VIII joint HURAS-NIP conference, in the framework of which the management of the agency conducts lectures and workshops. At the end of our conferences, we hold an interactive forum and provide an opportunity for open dialogues and discussions between our agency and our regulatory members. According to my knowledge, this is the one and only initiative of this kind and, as such, is unique within the whole Eastern Europe region.

LW: We’re always curious about views on the most important skills for the regulatory professional. In your experience, what comes to mind?

IS: I think that excellent communication skills with stakeholders, managing challenging situations and prioritisation of issues are the most important and essential professional skills in our daily regulatory work. Working in a rapidly changing legislative environment and for the pharmaceutical industry, where scientific innovations are being made daily, regulatory professionals must develop their professional knowledge accordingly in order to make sure that they have the latest information and advice – not only about recently introduced developments, but also those anticipated to come in the future. As this is mostly paperwork sitting in the office, the "good" regulatory professional should also be precise, assiduous and accurate.

LW: And what’s more important in the regulatory education- theory or practice? And what's the balance?

IS: Both are important, but the order of implementation is also crucial. One of the objectives for the foundation of our association 10 years ago was the realization that students studying in Hungarian universities do not receive an education on practical registration skills. Up to this day, our main goal is to support the continuous education of Hungarian professionals by organizing scientific lectures and workshops for them. For example, our association is the only professional body within Hungary that organises scientific academic lectures on pharmacovigilance and we have greatly contributed to the development of this important area of drug development. As regards practice, it is very important that after the participation in the required training, theoretical knowledge must be implemented in practice by starting to work within the agency or pharmaceutical industry. The best practice for a professional individual would be to gain expertise both in the field of agency activities and pharmaceutical industrial tasks. Unfortunately, due to the differences between the remuneration packages, most regulatory individuals have only the knowledge required within the industry but not within the agency. I hope that in the future, our government realises the importance of interoperability and in this way, the differences of remuneration between agency and industry will decrease or cease.

LW: We are very pleased that you have agreed to work with TOPRA to assist with our Annual Symposium. What are you hoping to get out of the partnership with TOPRA?

IS: I believe this will increase our technical and professional knowledge as well as extend our network of contacts and develop new skills. We know that TOPRA was the world’s first professional regulatory association and over the last years, it has become recognized as the gold standard for providing educational qualifications for the profession. As a small organisation, HURAS can learn a lot from working with TOPRA. All regulatory professionals are working in a rapidly changing legislative environment, and they need to make sure they have the most up-to-date professional information that they can rely on during their work. TOPRA training courses and conferences give real practical information that directly translates into the professional day-to-day needs of the regulatory area.

LW: Looking into the future, how do you hope the landscape for drugs and therapies will have changed in 10 years?

IS: As regards the future, I have optimistic views. I hope that the new accession member states of the EU will have reached the European level within 10 years and the results of our regulatory efforts of today will be clearly visible in the future. I also hope that the communication and cooperation between agencies and industry will show a considerable improvement which will greatly contribute to our common goal, namely, that patients, and providing patients with effective pharmaceutical treatments, must come first. However, we need to take into consideration that due to their economic difficulties and financial situation, our countries are not in a position to support innovative drugs on a large-scale. Therefore, I think that the developed Western European countries should provide their support to help the Eastern region in order to reach a higher level of growth and stay competitive as regards drug development. Innovation and research development has long traditions in Hungary. We hope that with the economic improvement and bridging of the political divide, the opportunity to integrate the existing local expertise and work culture will remain attractive for multinational companies.

LW: Mr. Slavov, Thank you very much.
IS: My pleasure.