Course description
Understanding and Preparing the Quality and Pharmaceutical Module of the Global CTD Dossier - a Pharma Training Course by PTI
This comprehensive three-day course will provide delegates with a clear understanding of the US and European regulatory requirements for Module 3 (CTD) of their application, and will show how to compile this important part of the submission dossier.
The course sessions will also examine the impact of the Common Technical Document. This course will enable participants to compile and submit Module 3 (CTD) of their registration dossier, ensure that Module 3 (CTD) of the dossier contains all data needed and achieve the quickest turnaround of your submission. Overall, it will enable them to deal effectively with regulators.
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Suitability - Who should attend?
This training programme is aimed at professionals specialising in Regulatory operations within the pharma industry.
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Expenses
The cost of this training course is £1995 + VAT per participant, which covers tuition and course materials.
In-house Training
PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.
“I enjoyed the hands-on sessions most. I wanted to learn about Module 3. It was a very good course; I learn a lot.” Regulatory Affairs Manager, Fresenius Kabi UK