Regulatory Affairs STAR Programme
About this course
Regulatory Affairs - Training Programme
Regulatory Affairs (RA) is essential to ensure that pharmaceutical products can be developed, authorised and maintained on the market and to guarantee that they are aligned with all applicable legislation and regulations. Read more about Regulatory Affairs: here.This training programme will provide you with a good introduction to the different areas and types of activities within Regulatory Affairs and with the knowledge to carry on or develop your career in any regulatory affairs department.You can now select:- Book the programme without the internships - only to attend the full week training (you can then choose to do the traineeships as a complement and pay the extra fee)
- Book the STAR Programme - apply for the programme (internships are included).
Steps to enrol:
- Fill out the application form Online / Document
- Submit your application form with your CV and motivation letter
- Intake conversation with a mentor
- If accepted, book the programme to ensure your seat
- Payment of the full programme can be done the day before the starting date
Course Description
This training programme will provide you with the capabilities you need to become a Junior Regulatory Affairs Associate, with a full week of training and a full year of internships to develop your fullest potential and boost your chances to start or evolve in your career in RA.- Pharmaceutical company OR consultancy company - 6 months
Programme highlight
The training week covers all the topics to help you have a clear understanding of all the activities, requirements and roles in the Regulatory Affairs field. The topics include:
- Introductions
- Life Cycle of a pharmaceutical product
- Submission for MA in EU
- Submission for MA in a non-EU country/ US
- Chemistry, Manufacturing & Controls (CMC)
- Good Manufacturing Practices, Labeling
- Good distribution Practices Guidelines
- Regulatory Policy & Intelligence
- Pharmacovigilance
- Information and publicity
Learning objectives
Covered during the week of training:
- Find your way into the regulatory space
- Understand the framework
- Understand the different roles involved: companies, regulatory agencies, stakeholders, etc.
- Know the processes from a product development to launch into the market
- Understand what are the global regulatory activities and the local regulatory activities and duties.
- Get acquainted with a number of areas within regulatory affairs (job rotations)
- Orient yourself in the area where you have the most affinity with
- Give you the practical experience to understand and perform the actual duties in the role
- Mentoring by the organisation and ECCRT
Who should attend
Students that completed their Masters’ degree in life sciences (such as pharmacy, biology, biomedical, chemistry, bio-engineering, biomedical engineering, physiotherapists, molecular biologists, etc.).
Anyone aiming to begin their career in Regulatory Affairs without previous relevant experience or interested in re-orienting their professional activities.Competencies
The STAR Progamme covers all the competencies required for a Junior Regulatory Affairs Professional
Juliette Moyersoen
Alex Stopar
Joana Reis Pedro
Mopelola Adegun
Michela Lisjak