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Editor of Pharmaceutical Technology Europe
A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.
As the safety and efficacy of pharmaceutical products is of paramount importance, it is unsurprising that the industry is subject to strict regulations. Within Europe alone, the regulatory system for medicines comprises a network of approximately 50 regulatory authorities, which are based throughout the 31 countries of the European Economic Area (EEA), as well as within the European Commission, and the European Medicines Agency (EMA).
Cooperation between scientific experts across Europe is, therefore, an integral part of the European regulatory system. Through sharing knowledge, information, and expertise across the region, assessment of new medicines and new safety information can be performed to the highest possible quality.
However, the European regulatory landscape is currently undergoing a raft of changes, not least of all because of Brexit but also as a result of pending regulations, set to come into force in the near future. To tackle the issues facing the European regulatory community, the Regulatory Affairs Professionals Society (RAPS) has launched a conference in Brussels, Belgium, 13–14 May. Pharmaceutical Technology Europe spoke with Paul Brooks, executive director of the society, to learn more about the conference.
PTE: Could you provide a brief overview of the conference, highlighting the main reasons for its launch?
Brooks (RAPS): The inaugural RAPS Regulatory Conference Europe 2019 will bring together pharmaceutical, medical device, and in-vitro diagnostic (IVD) device industry experts, thought leaders, practitioners, and prominent health authority representatives to examine the most critical regulatory challenges and opportunities in Europe at the moment. Speakers and attendees will share the latest available information, ideas, and best practices.
Our European members and others in the European regulatory community have been calling for RAPS to host a conference in Europe, something focused specifically on their major needs and concerns. And with so much of Europe’s regulatory system in flux right now, the need is more urgent than ever. This conference has been purposely designed and developed by European regulatory professionals specifically to address the tough issues regulatory professionals working in Europe are currently contending with.
PTE: What topics will the inaugural conference agenda cover?
Brooks (RAPS): The conference agenda will cover a wide range of current issues facing pharma, medical device, and IVD regulatory professionals, as well as some overarching areas that impact all professionals in the healthcare products space.
Clearly, the potential impact of Brexit on regulatory systems, processes, and the supply and availability of critical medicines and medical technology is paramount on the minds of everyone working in health and medicine. The pending EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will bring sweeping changes to the medtech world. MDR’s effect on drug-device combination products also will be discussed.
Other sessions of particular interest to those working in pharma will cover EMA’s priority medicines (PRIME) scheme, paediatric studies, non-biological complex drug follow-on products, and regulator expectations for quality risk management of medicines throughout the product lifecycle, among other topics.
This conference will cover all of that and more, so attendees will find sessions relevant to their main focus, whatever area they may work in. The sessions are grouped into specific topic tracks covering pharma, medical devices, and general regulatory issues, along with tracks specifically devoted to MDR and IVDR. Therefore, attendees can focus on the sessions within a particular topic area or attend sessions on multiple tracks to suit their individual needs.
PTE: In your opinion, how important is it for regulatory professionals to come together in forums such as the RAPS conference and how will it be beneficial to those attending?
Brooks (RAPS): Not only does this conference provide access to regulatory experts and leaders, it is an opportunity for the European regulatory community to come together, connect with one another and build relationships. One of the key benefits of a conference like this one and of being involved with an organization like RAPS is the chance to be part of a mutually supportive professional community.
PTE: Will Brexit be an overwhelming part of discussions during the conference?
Brooks (RAPS): There is no doubt Brexit will be among the most discussed topics, both formally in conference sessions and informally between sessions, during receptions, and over meals. Right now, nothing about Brexit is certain. We don’t know whether or not a deal will be struck. We don’t know what a potential deal may look like or what the relationship will be between UK and EU authorities. We don’t know how UK’s need to now participate in EU parliamentary elections might introduce new political pressures regarding Brexit negotiations. We are even starting to hear more speculation that there could be a second referendum, offering the possibility that the UK changes course and remains part of the EU.
While this lack of certainty can be unsettling, the regulatory profession is partly about planning for contingencies and being ready for multiple possible scenarios. Regulatory leaders can’t wait until they have all the answers; they must work to address challenges as they go, based on their best judgement, experience, and informed interpretations.
PTE: Will the conference take place annually and if so, which topics do you believe will be prominent in future conferences?
Brooks (RAPS): We are already planning for a 2020 conference, which will again be in Brussels. The critical regulatory issues mentioned earlier are likely to be high on the list of priorities in the pharma, device, and IVD sectors for some time. They will develop and evolve, but they are not going away as major concerns.
The RAPS Regulatory Europe Conference agenda will continue to be driven by the needs of the regulatory community in Europe and also will evolve to meet those needs.
Pharmaceutical Technology Europe
Volume 31, No. 5
When referring to this article, please cite it as F. Thomas, "A Meeting of Minds,"Pharmaceutical Technology Europe 31 (5) 2019.