Course description
eCTD Submissions - a Pharma Training Course by PTI
Global regulatory agencies are committed to implemeting the eCTD as benchmark. Attending this practical two-day training course by PTI, pharma company representatives can ensure their applications are in the correct electronic format and style from the onset. By the end of this course, participants will have learnt how to:
- Implement more efficient processes to build, publish and deliver regulatory submissions
- Understand the challenges of adopting the eCTD on a global scale
- Understand regulatory requirements and improve your agency communications
- Monitor and manage multiple agency submissions with effective life cycle management
- Identify the latest challenges presented by the new eCTD validation criteria
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Suitability - Who should attend?
This training programme is aimed at professionals specialising in regulatory affairs within the pharma industry and especially those with the following responsibilities:
- Dossier Management
- Document Management
- Data Management
- Compliance
- Electronic Publishing/ Submissions
- Global Project Management
- IT/IS
- EDMS
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
Average rating 4.8
“The global aspect attracted me.” Regulatory Operation System Manager.” Bio Products Laboratory Ltd.
The information provided in this training and the size of the group made it a very enjoyable course to undertake.
Expenses
The cost of this training course is £1595 + 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.
“The trainers adjusted the content/order of the presentations to suit those on the course. I took this course as we plan to submit our first Ectd this coming September.” Regulat...