Regulatory Affairs - Week training
Regulatory Affairs (RA) is a not well-known field in which multiple career opportunities lie ahead for anyone wanting to start their career in the pharmaceutical sector.
This training programme will provide you with a good understanding of the different areas and activities within regulatory affairs and with the knowledge to carry on or develop your career in any regulatory affairs department.
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 an optional full year of traineeship to develop your fullest potential and boost your chances to start or evolve in your career in RA.
The traineeships will take place:
- In a pharmaceutical company for 6 months
- And in another pharma company or a Contract Research Organisation (CRO) for 6 months
The traineeships can be taken in any location depending on ECCRT approval. How can you apply for this STAR programme? Fill in the application form. Application is subject to approval (after an interview) and does not automatically result in enrolment.
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The training week covers all the topics to help you have a clear glimpse of all the activities, requirements and roles in the Regulatory Affairs field. The topics include:
1. Introductions
2. Life Cycle of a pharmaceutical product
3. Submission for Marketing Authorisation (MA) in the EU
4. Submission for MA in a non-EU country/ US
5. Chemistry, Manufacturing & Controls (CMC)
6. Good Manufacturing Practices, Labelling
7. Good distribution Practices Guidelines
8. Regulatory Policy & Intelligence
9. Pharmacovigilance
10. Information and publicity