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Filing Variations

Course summary
2 days
1,595 GBP excl. VAT
Amsterdam, London, Online courses, Prague
Next available date: 15/07/2020 - Online courses
Professional Training

Course description

Filing Variations

Filing Variations - 2-Day training course by PTI

This two-day course is designed to guide delegates through the challenges and issues of filing variations. Course material focuses on the legislation changes to Variations to Marketing Authorisations. Participants will work through a variety of exercises and case studies covering regulatory goals.

An interactive program

This course provides a complete update to the latest changes to variation guidelines in the EU. Delegates will gain highly practical skills through the use case studies, group discussions, simulations and assessments.


In light of the uncertain times we’re facing at the moment, gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. 

Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-2 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Suitability - Who should attend?

This Filing Variations training course is intended for Regulatory Affairs participating in filing. Those best suited for this course will likely work in:

  • Regulatory Affairs
  • Dossier registration department
  • Product Information
  • RA compliance
  • Other disciplines impacting the process of filing Variations, such as manufacturing, development, clinical safety, pharmacovigilance

Training Course Content

Training topics for this course include:

  • Variations procedures that achieve faster approval
  • Practical hurdles of submitting Variations on time and with the right supporting data 
  • The impact of the CTD on the Variation dossier
  • Collect and present complete information on Variations
  • Streamline 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:


85% had applied content during the course to their role

Delivery rating:



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.

About provider

PTI - Pharmaceutical Training International

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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Average rating 4.8

Based on 10 reviews

Senior Regulatory Affairs Officer, HAL Allergy
The interaction and discussion of the particular ‘real-life’ examples as well as sharing experiences with different countries was very beneficial.
Global CMC Regulatory Affairs Consultant, Bioreg Consultancy Limited
The fact that there were small groups, with great content and hands-on exercises, made it a very good course.
Regulatory Affairs Executive, Bimeda
The interactive aspect and the practical sessions were particularly enjoyable.
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Course rating
Based on 10 reviews
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