The online Drug Dossier Preparation and filing provides practical training on drug registration dossier preparation and submission process. In fact, this course provides real life training on how to prepare drug submission dossier effectively. Hence, This online certificate course in drug dossier preparation and registration is ideal for regulatory affairs, Quality personnel, Business Development and International Marketing professionals working in the pharmaceutical industry. Moreover, this course gives hands-on training through simulation on dossier preparation, which helps to improve the dossier compilation process.
Online Interactive Training
This online self paced training. Therefore the course can be accessed 24×7 across anywhere. Hence, the course can be completed at any pace, allowing the user to stop and start at their leisure.
Course Code: RYD-024
Course Title: Competency Development Program in Drug Dossier Preparations and Filing
This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for different regulatory bodies and practical exposure in drug dossier preparation. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
Features of the Course:
- The course provides practical training on drug dossier preparation and submission. Therefore it helps the students to identify the marketing tools and techniques which are commonly used in the pharmaceutical industry.
- Most importantly, course provides advanced simulation to real life working in drug dossier preparation and submission process.
- Therefore, this course helps to understand submission requirement specific to regulatory agency.
- Above all, this course provides access to sample dossier to work and develop competency. Certainly, accessing these real life dossiers can be helpful for students to understand section wise requirements for the dossier preparation.
Key Points to Note:
First of all, this course provides practical understanding in the entire drug submission requirement specific to different regulatory bodies.
Secondly, hands on training is provided on key aspects of the drug dossier preparation with focus on guidelines on dossier preparation.
Thirdly, courses comes with the how to prepare the different sections of dossier. In fact, insight is provide on Page by page development of Drug Dossier Preparation.
Next, one more important point is, this course provides comprehensive understanding on drug master file and site master file preparation.,
To add a note, comprehensive eCTD filing, stability study, documentation error, data integrity and other dossier filing is part of this course.
Online learning course. So course can be accessed online across anywhere 24×7.
Graduation in any discipline. Even final year graduation students can apply.
1 Week from the date of initiation of the course.
- Attend the course 24×7 by login to your dashboard. Therefore, you can attend lectures, simulation, self assessment tests and final certification examination at your own preferred time.
- You will also eligible to receive the course study modules, which you can download by login to your course page.
Certificate will be provided at the end of the successful completion of the course.
Some related courses
- Those who enrolled for the course will be eligible to upgrade to Pharmaceutical International Business Management course by paying the difference in the course fees.