Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements. Key duties of the job include: studying scientific and legal documents. gathering, evaluating, organising, managing and collating information in a variety of formats.
Why this course ?
Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements. ... planning, undertaking and overseeing product trials and regulatory inspections. keeping up to date with changes in regulatory legislation and guidelines.
Weekends (60 Hours )
Weekend Class Room | 9.30 AM - 12.30 PM
Weekends (60 Hours )
Weekend Online | 9.30 AM - 12.30 PM
There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
Live project based on any of the selected use cases on the above selected Domain.
Each class will be followed by practical assignments which can be completed before the next class.
We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.
Regulatory Affairs Certification (RAC)
Topic 1: Introduction to RA
Topic 2: ICH guidelines
Topic 3: CTD – eCTD
Topic 4: Drug Development Process.
Topic 5: Generic Drugs
Topic 6: Drug approval procedure in US
Topic 7: Drug approval procedure in Europe
Topic 8: Discussion on deficiencies received from authorities and how to address the quires effectively.
Topic 9: Project work with hands on experience in dossier compilation activity.
Topic 10: Resume preparation and interview questions.
Project on Regulatory Affairs Certification (RAC)
Realtime project on Regulatory Affairs Certification (RAC)
Can I attend a demo session before enrollment?
What if I miss a class ?
If you miss a class we can provide recording video for particular session or we can arrange you the back up session.
Will I get placement Assistance ?
Do I receive a certificate for training ?
What support is available after the training?
Doubts clarification up to getting a job
What Features do you provide?
Class Room & Online Live sessions
Covalent provides training certificate after completion of the course.