The skills gap in medicines and device regulatory affairs is leaving organisations short of staff at a time when there is more to do than ever before. TOPRA is supporting the profession to help fill this gap in several ways, including this apprenticeship.
TOPRA facilitated a multi-stakeholder employer group to design the apprenticeship standard and supporting tools, and TOPRA is a registered training provider.
What is the apprenticeship?
An apprenticeship is a work-based training programme designed around the needs of employers, which can lead to nationally and internationally recognised qualifications.
The training is based on the apprenticeship Standard which sets out the knowledge, skills and behaviours an apprentice needs to develop over the course of the programme. The Regulatory Affairs Specialist Standard was created by professionals working in a variety of organisations covering pharmaceuticals and medical devices.
The apprenticeship programme takes 30 months and provides Masters-level training in regulatory affairs. It requires apprentices to spend 20% of their time on regulatory training, with the other 80% spent working and gaining experience.
Apprentices complete assessments at the end of the apprenticeship to ensure they have developed the knowledge, skills and behaviours that the programme has set out to impart. They will also complete assessments during the training programme to help embed their training and to monitor their progress.