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Fundamentals of European Regulatory Affairs

PTI
Course summary
3 days
Full time
London
Professional Training

Course description

Intro to European Regulatory Affairs

Fundamentals of European Regulatory Affairs - 3-day training course by PTI

This course is designed to guide RA professionals through the necessary regulatory skills and understanding for optimising drug submission procedures. Course participants will gain the tools for ensuring that submissions meet the standards required by the regulators.

A practical, hands-on course

The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to daily work.

Suitability - Who should attend?

This Introduction to European Regulatory Affairs training course is aimed at new regulatory affairs professionals in the pharmaceuticals industry looking for a clear overview of all aspects of the European regulatory environment.

Outcome / Qualification etc.

Upon completion of this programme, participants will be prepared to:

  • Make a clinical trial application in the EU
  • Clarify how the Centralised Procedure works and the function of CHMP
  • Integrate CTD requirements from the start of your submissions
  • Facilitate successful review of your dossier by preparing a strong dossier
  • Allow a smooth product development programme
  • Gain faster response from the Regulators through better negotiations

Training Course Content

Training topics for this course include:

  • Speed-up the MAA
  • Integrate CTD requirements
  • Gain faster response from the regulators
  • Compile and present the key information
  • Maintain your license
  • Reduce early, or late stage, set backs in the registration procedure
  • Improve your dossier compilation process
  • Facilitate your drug’s successful review
  • Take into consideration the patent situation

 

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

Expenses

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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Contact info

PTI

London

 Show phone number
http://www.pti-global.co.uk

Reviews

Average rating 4.8

Based on 11 reviews

Regulatory Publisher, Novo Nordisk
(5)
The online sessions allowed me flexibility to fit training into my busy work schedule.
Senior RA Coordinator, Genmab A/S.
(5)
This course suited me perfectly in a busy time period. The possibility of completing each module around my schedule was very appealing. If you have little or no experience of the regulatory world, I would recommend this course as it gives a good overview of the full regulatory dossier.
Regulatory Affairs Officer, Eurogenetics
(5)
“The practical case studies which made you consider all aspects of the course was great.”
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Reviews
Course rating
(4.8)
Based on 11 reviews
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