Who? The Regulatory Affairs Professionals Society (RAPS) is a global organization for regulatory professionals in the healthcare, medical device, biologic and pharmaceutical sectors. What? RAPS is increasing its investment in Europe. Over the last 12 months, we have seen our existing European member base grow by approximately 19 percent – to more than 1,500 members across 29 countries. In addition, important regulatory developments in Europe, such as the imminent introduction of the Medical Device Regulation (MDR) and the Falsified Medicines Directive (FMD), are creating the need for greater support for regulatory professionals in this sector.
Why? Changes to medical device regulations in Europe present a huge challenge to manufacturers. The MDR is high on the industry’s agenda as we move towards the 2020 deadline and is a major source of discussion and resource for our members. We strive to keep our members abreast of these regulations and the implications they bring with regular updates and events. Similarly, the pharmaceutical supply chain is currently faced with the huge task of preparing for the introduction of the European FMD, which comes into effect in 2019. New track-and-trace requirements are also being introduced in the US as part of the Drug Supply Chain Security Act in 2017. There are, therefore, lessons that can be transferred across geographies and it is our goal to connect regulatory professionals in different markets, allowing for knowledge sharing and the adoption of best practice. The increasing use of electronic common technical documents (eCTDs) in the industry is also proving a challenge for many, and it is our goal to assist our members with this transition by providing training and guidance. How? RAPS will invest more than €2 million over three years to implement its growth plan in Europe, which includes the opening of its first European office. The office, which will be the European HQ, will be a base for activity across the entire European regulatory community. In addition, RAPS has announced a series of European events including a RAPS Roadshow. The next event takes places in July in Brussels: “EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations”.
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