Pilot III - Implementing the Comprehensive Curriculum

The Pilot gave a first insight into essential information and knowledge to develop especially innovative medicinal products alongside the requirements to bring high quality, safe and efficacious products to the European market. The Pilot is now closed.

Pilot III is one of three pilots in the EU-funded STARS project and represents the implementation of the Comprehensive Curriculum for strengthening regulatory knowledge in academia. It was planned and performed by AEMPS (Spanish Agency of Medicines and Medical Devices) in cooperation with  PEI (Paul Ehrlich Institute, Germany) and OGYÉI (National Institute of Pharmacy and Nutrition, Hungary), and supported by DLR Projektträger (German Aerospace Center, Germany).

The STARS Curricula in Regulatory Science consist of 5 modules: The STARS Core Curriculum (1 module) and the STARS Comprehensive Curriculum (4 modules) (Figure 1).

Pilot III was open 16 February 2022 to 16 March 2022 and focused on the STARS Core Curriculum module, including also some information from the other 4 modules. The Pilot gave a first insight into essential information and knowledge to develop especially innovative medicinal products alongside the requirements to bring high quality, safe and efficacious products to the European market.

Pilot III was provided free of charge, but registered attendees were kindly asked to participate in a survey after downloading the presentation. In case of any queries about the Pilot feel free to contact us:

stars_pilot3@aemps.es

The concept of Pilot III

The rapid expansion of pharmaceutical and biomedical products and increasing complexity of innovative technologies and products tend to start in non-commercial research institutions. To bridge the translational gap highly skilled professionals need to be trained in regulatory knowledge to conduct research in compliance with complex regulatory policies and challenging procedures.

The STARS Comprehensive Curriculum (CpC) consists of 5 modules: Core Curriculum module and 4 more module: Quality module, Non-clinical module, Clinical module and post-marketing surveillance module. All modules provide decisive information and knowledge to develop especially innovative medicinal products alongside the regulatory requirements to bring high quality, safety, and efficacy medicinal products to the European market.

Taking into account the time constraint for the project, Pilot III focused on the STARS Core Curriculum module, giving some information on the topics included in the other modules (Figure 1).

The format of the Pilot III was based on a presentation called “Regulatory Support to Spanish Academia from STARS Core to Comprehensive Curriculum” with the aim of extending it in the future including all the points detailed on each of the modules.

The content of the Core Curriculum gives an overview of regulatory requirements at a general level, introducing the four special modules focusing on each of the above-mentioned areas throughout the whole medicinal product life cycle. This specialised education is a key entrance tool for clinical researchers and scientists to understand the legal regulatory requirements, to get familiar with the specific guidelines alongside the whole product life cycle and to learn about the timely use of the NCA support activities during the development of their products (Figure 11).

The overarching goal for the researchers is to successfully translate research into clinical development of medicinal products to reach as soon as possible to patients.

The complete content of the CpC is summarised in figure 1:

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Figure 1. STARS Curricula in Regulatory Science © STARS project 

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