The Quality and Pharmaceutical Module (Module 3) of the Common Technical Document (CTD) is arguably the most challenging aspect of regulatory approval and requires considerable expertise to navigate it successfully. This detailed, 10 module course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 of your application and will show you how to compile this important part of your submission dossier.
Once completed you will have the skill and confidence to complete the Module 3 section of the CTD, and ensure the correct structure is maintained enabling you to work more effectively with regulators. Importantly, you will learn best practices to complete the Module faster and overcome regulators' questions to fast track submission times and get your products to market quickly.
Pharmaceutical Training International online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.
Over 5 weeks students will learn through:
- 10 modules, split up into multiple bitesize recorded videos
- Quizzes to test your knowledge
- Revisiting the content with unlimited access to all the materials for 3 months
- Participating in the discussion forum to interact with other students
- Interacting with the trainer through the forum during the course
- Additional content such as materials and white papers available to download
Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org.
What will you learn?
Compile and submit the Quality and Pharmaceutical section of your registration dossier
Ensure all data needed has been collected and I suitable for development and manufacturing groups
Deal effectively with Regulators: Meeting the legal framework and guidelines for the CMC/ Quality part of the dossier, and links to GMP
Quality by Design
Quality by Design
Incorporate Quality by Design into your CTD requirements and create the optimal Module 3
Understand the regulatory legal framework and influences on your Module 3 style
Build Module 3 (CTD) of the dossier to meet regulatory requirements
Know the legal framework and guidelines for the CMC/Quality part of the dossier
Who is this course for?
This course has been specifically designed to address the needs of:
- Regulatory Affairs Managers/ Officers/ Assistants
- Compliance Managers
- Documentation Managers
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Qualified Persons
- Key contributors to the submission package
Find out more about online academies...
PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
On average, delegates of our online academies said...
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.