Course description
Filing Variations
Managing regulatory change forfilingvariationsis a complex and challenging procedure. The regulatory requirements highlight the need for successfulvariationsstrategies across regulatory teams. It is therefore important for you to understand the regulations, definitions and best practice for implementation.
This course will teach you how to optimise your procedures for faster, streamlined and compliant variation submissions. The course contains exercises and case studies to help you understand the variation requirements and meet your regulatory goals. You will examine the various types ofvariationsfrom mutual recognition to type II and centralised procedurevariations. You will also discuss how best to approach grouping and worksharing so you know when to apply it to yourvariations.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
This course will be beneficial to Regulatory Affairs personnel who take part in filing variations such as:
- Regulatory Affairs
- Dossier registration department
- Product Information
- RA compliance
- Personnel from other disciplines who have an impact on the process of filing Variations, such as manufacturing, development, clinical safety and pharmacovigilance.
Training Course Content
Clarify the latest Variations revisions:
- Formulate Variations procedures that achieve faster approval
- Manage the practical hurdles of submitting your Variations on time and with the right supporting data
- Understand the impact of the CTD on your Variation dossier
- Collect and present complete information on your Variations
- Streamline your Variation procedures for international applications
- Tackle the challenges of type II Variations under the MRP
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 fact that there were small groups, with great content and hands-on exercises, made it a very good course.
The interactive aspect and the practical sessions were particularly enjoyable.
The interaction and discussion of the particular ‘real-life’ examples as well as sharing experiences with different countries was very beneficial.