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Developed by European regulatory professionals for regulatory professionals operating in Europe’s quickly changing and uncertain regulatory environment, RAPS European workshops bring together leading experts in the medical device, IVD and pharmaceutical industries.
Join us for one of the workshops below to gain insight into some of the most urgent and crucial issues facing regulators, manufacturers and regulatory professionals working with healthcare products for the European market.
14 December 2021 - 15 December 2021
To comply with MDR clinical evidence rules, manufacturers have turned to cost-effective tools to create clinical data and turn them into clinical evidence. We will guide you through the benefits and pitfalls of this middle road to clinical safety.
15 February 2022 - 16 February 2022
Members: € 945 Nonmembers: € 1,120 Although much is clear in the IVD-R text, as the saying goes "the devil is in the details" and there are lots of areas still open to interpretation and which need further guidance.
Members: € 945 Nonmembers: € 1,120 Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
17 February 2022 - 18 February 2022
Members: € 945 Nonmembers: € 1120 Gain the knowledge you need to navigate global cybersecurity expectations, translate regulatory expectations into concrete design and development activities and establish trust with customers.
17 February 2022
Members: € 555 Nonmembers: € 650 Learn which aspects to consider when writing a regulatory plan, along with several pathways to speed up development, including PRIME and adaptive pathways.
18 February 2022
Members: € 550 Nonmembers: € 650 Learn how changes for assessment and approval of multinational clinical trial authorization applications will impact trials conducted inside and outside the EU to avoid delays and minimize the time for approval.