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Introduction to European Regulatory Affairs

Course summary
3 days
Professional Training

Course description

Introduction to European Regulatory Affairs

Introduction to European Regulatory Affairs - a Pharma Training Course by PTI

This training course will provide you with a clear understanding of the EU regulatory structure and ensure that your submissions meet the standards required by the regulators.

The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier.

Suitability - Who should attend?

This training programme is aimed at professionals specialising in Regulatory operations within the pharma industry.

Outcome / Qualification etc.

On successful completion of this programme, delegates will gain 12 CPD points, counting towards their continuous professional development record.

Course instructor bio

Ann Godsell now runs her own Regulatory Affairs Consultancy. She has worked in the field of regulatory affairs for over 20 years, with further experience in the pharmaceutical industry in quality assurance prior to this. She has worked for various companies in a wealth of roles, which have involved all aspects of regulatory, with projects relating to all stages in a product lifecycle from early clinical development through to working with established large commercially successful brands, managing regulatory affairs and providing both strategic advice and operational support.

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:



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 5

Based on 5 reviews

Senior Academic Alliances Counsel, AstraZeneca
This course provided a very detailed overview of the subject matter. I enjoyed the way the course was delivered, the knowledge and the enthusiasm of the trainer. She was a fantastic teacher and knowledge sharer.
Analytical Operations Manager, Orchard Therapeutics
I enjoyed the practical sessions. There was a clear overview of the EU regulations and it provided me with tools and guidelines to look at - very helpful.
QA Officer (Regulatory Affairs), Phamacare Premium Ltd
The friendly environment and knowledge which was shared along with the resources were very helpful. Great organisation.
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Course rating
Based on 5 reviews
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