TOPRA 2025

profession as a whole and for the wider benefit of society and public health. TOPRA prides itself on providing an ideal forum in which neutral discussions about regulatory issues can take place, eg, on potential impacts and consequences of proposed regulations and guidelines. These discussions can take place on a small scale within Roundtables, or at a higher level in Summits, the Annual Symposia or single issue- focused Horizon conferences. TOPRA does not give an opinion on consultations, but as a professional association we provide a means for individual regulatory professionals to share their observations and get their voices heard, especially if they are not able to comment on public consultations via their employers or trade associations. This neutrality and regulatory expertise enables TOPRA to work closely with allied professional groups, governmental and regulatory authorities at national and international level.

TOPRA members’ knowledge, expertise and experience is beneficial to our stakeholders in the endeavour to support healthcare providers and practitioners provide better, safer and more innovative treatments to patients. to professionalism by signing up to a Statement of Values, and undertaking continuing professional development. Members are also eligible to apply for professional registration as Chartered Scientists or Registered Scientists as TOPRA is an awarding body for the Science Council. A neutral forum TOPRA membership is individual and personal. Our members come from all backgrounds, specialties and types of organisation. They come together not only to develop themselves but to contribute to the development of the

CASE STUDY Embracing the patient perspective

Among the many examples of regulators and drug developers engaging with patients in order to develop better medicines is an initiative by Swissmedic (Swiss Agency for Therapeutic Products). Cordula Landgraf is the agency’s former Head of Networking and has led the project through the pilot stages to the establishment of the Patient and Consumer Group as a permanent standing group in February 2019. She described the group’s development at a TOPRA Summit. Swissmedic increased patient involvement in its processes in a step-by-step approach. Transparency and training are key to enabling patients and consumers to become more involved in decision-making processes. The initiative started in 2016 with training of a heterogenous group of patients in order to help everyone get to a similar level of understanding. The first input was into patient information leaflets (PILs) assessments with the group feeding back to companies applying for marketing authorisations before submission to Swissmedic. Plans for the standing Patient and Consumer Group include helping to review the SwissPAR lay summary and safety communications.

Cordula Landgraf

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