Module 3 of the Global CTD (LIVE online)
The Quality and Pharmaceutical Module (Module 3) of the Common Technical Document (CTD) is a critical element of the submission process and must be navigated with skill to minimise delays. This 3-day course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 (CTD) of your application, and will show you how to compile this important part of your submission dossier.
You will become more confident in your daily practices after three days of intensive lectures, group work, and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your dossier. Once completed you will have be able to compile and submit Module 3 (CTD) of your registration dossier, ensuring your dossier contains all the relevant data needed. You will also have the skill to submit the Module 3 quickly, speeding up the overall submission and approval process.
Suitability - Who should attend?
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
Outcome / Qualification etc.
- Build Module 3 (CTD) of the dossier to meet regulatory requirements
- Understand the legal framework and guidelines for the CMC/Quality part of the dossier
- Meet the legal responsibilities of the manufacturing authorisation holder, and the designated qualified person
- Write the application with a view to product maintenance and consistent supply
- Define the impact of the Common Technical Document on the Quality section of the dossier
- Write variation submissions for Europe and get approval first time
- Structure your submission teams to ensure compliance
- Link your dossier requirements to GMP
- Minimise delays in your submission by providing accurate documentation
- Use certificate of suitability as replacement of data
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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