Module 0 - Introduction to EU Regulatory Affairs

TOPRA is pleased to announce its new academic progression route for regulatory professionals. The ‘TOPRA Introductory Courses’ will be a new MSc Module embedded into the curriculum, entitled: “Introduction to EU Regulatory Affairs.” This new pathway will allow students (who do not meet the entry criteria) to undertake the assessments of the new Module and begin their MSc course.

Thus delegates will be able to attend the Introductory Course and receive a thorough grounding in all the main pharmaceutical and device regulatory aspects and then have the opportunity complete the assignments of their first MSc Module. It is envisaged that this will then ‘kick start’ these students on to the MSc Course and will then only require them to complete the remaining seven modules over the next five years.

New Module development and rationale
This module will differ from the other existing 12 modules, in that it will be discretely embedded into the introductory course programme and will be available as a ‘stand alone’ Module for existing and or future MSc students and form part of the overall Introductory course.

Unlike the other modules this will be available every year to new and existing students at the UK Spring course and EU Autumn course and will follow the same assessment methodology and study hours that exist for the other MSc Modules.

Benefits for the inclusion of the module are that;

• It will enable students to ‘kick start’ their MSc studies
• The overview provided by the module will provide a good introduction and understanding of EU drug development and the role of Regulatory Affairs for new professionals working in the sector.
• It will help to give new students the opportunity to obtain a professional qualification upon completion of the Introductory Course, whilst providing a clear progression route for new students wanting to develop their regulatory expertise on to the MSc course.

N.B. Please note that completion of the MSc module assessments is voluntary for all attendees of the Introductory Course.

Further Information
Up to this time the existing MSc course was independent of TOPRA’s other educational programmes and consisted of a series of 12 free-standing modules delivered over a three year cycle, with students studying for the MSc being required to attend eight modules within a minimum of two and maximum of five years.
Students are required to satisfy the examiners in eight modules by completion of a course journal and written assignments for each module.
Students must then submit an MSc dissertation of 18,000 – 20,000 words to obtain their full ‘Masters of Science’ qualification.