Understanding EU Regulatory Affairs

23 September 2024 | 1 Week Live Online Course

Original price was: £1,195.00.Current price is: £795.00.

(7 customer reviews)

The price is for all sessions below Register for Module 1-Free

Gain a comprehensive overview of EU (bio)pharmaceutical regulatory affairs

Register For Module 1 | Free-To-Attend


Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.

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Enrol before 11 September February to save £400

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Course Overview


Regulatory affairs is an essential function within the pharmaceutical and biotech industries to ensure patient safety. Regulations exist to ensure all products are safe and effective for use. Regulators such as the EMA, MHRA and HPRA make sure all products on the market meet the safety and quality requirements. Regulatory requirements impact all departments in a (bio)pharmaceutical company, so it is critical for professionals to have a basic understanding of what they are.


This course will provide a clear understanding of the procedures involved in obtaining and maintaining market authorisations for medicines in the European Union. You will discuss the EU legislative framework and regulatory procedures for MAA submission. You will examine the regulations throughout the product life cycle, from product development and submissions to post market obligations. Once completed, you will have a solid awareness of the importance of regulatory affairs in your role and organisation.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver classroom and live online training.

Course Dates


Find out when this course is running so you can plan your training.

23 September 2024

1 Week Live Online Training
Register at the top of the page.


2025 Dates TBC

1 Week Live Online Training

Get in touch to register for these dates. The largest price saving of £400 will be applied.

Key Learning Objectives


  • Gain a complete grounding in EU regulatory affairs from product development and submission dossier to labelling and pharmacovigilance
  • Discuss the various types of Marketing Authorisation Applications (MAA) to pick the optimal submission
  • Examine regulatory affairs during pre-clinical and clinical stages of product development
  • Understand how to ensure your regulatory processes can be as efficient and effective as possible
  • Review the different modules in the Common Technical Document (CTD) to build a submission dossier
  • Understand the requirements of packaging and labelling pharmaceutical products in the EU.
  • Ensure you are aware of the post market expectations of life cycle management such as good pharmacovigilance practice, renewals and filing variations
  • Appreciate the differences in regulatory process between small molecules and biopharmaceuticals

What is Included in a Live Online Course?


  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 to 5 weeks after the last session
  • Reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance is available for you to download

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Module 1
FREE to Attend | Live & Recorded

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21 August 2024 | 60 mins | 1:00 PM UK

Understanding the EU regulatory framework

This module will provide you with a complete overview of the EU regulatory framework. You will discuss the various stakeholders involved and the current legislative system in place.

  • Review the various regulatory bodies
  • Understand competent authorities
  • Legislative framework
  • Examine the four regulatory areas – medicine, medical device, food supplement and cosmetics
  • For medicines – learn about the EU pharmaceutical law and where to find it

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

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Session 1

23 September 2024 | 90 mins | 1:00 PM UK

Regulatory affairs during product development

This module will discuss regulatory affairs for product development. You will examine both non-clinical and clinical expectations.


Review regulatory affairs during non-clinical:

  • The Target Product Profile
  • Non-clinical development
  • Toxicology
  • Pharmacokinetics and toxicokinetics
  • Environmental risk assessment


Examine regulatory affairs during clinical studies:

  • The Clinical Trial Regulation (CTR)
  • Regulatory and ethical approval guidance
  • Good Clinical Practices (GCP)
  • Reviewing clinical trials in children
Session 2

24 September 2024 | 90 mins | 1:00 PM UK

MAA – Regulatory submission procedures

This module will focus on the different procedures for different submission types and strategies for them.

  • Centralised
  • Decentralised procedure
  • Mutual Recognition procedure
  • Review special cases: Orphan drugs, paediatric medicines, advanced therapies, herbal medicinal products
  • What is scientific advice (SA)

Practical group work 
Interactive group exercise using the break out rooms. This is designed to cement your knowledge.

Session 3

25 September 2024 | 120 mins | 1:00 PM UK

MAA – The registration dossier

This module will provide an overview of the Common Technical Document (CTD) and the requirements and expectations for the 5 different modules.

  • GxP and the marketing authorisation dossier
  • Detailed review the Common Technical Document (CTD) examining the various modules: Module 1 to 5
  • Electronic submissions: NeeS and eCTD

MAA – Labelling and packaging

This module will discuss the various guidelines and directives for labelling and patient information leaflets (PILs)

  • Overview of the directives and guidelines
  • Examine SmPC requirements
  • Understand labelling requirements
  • Examine Patient Information Leaflets (PILs) in Europe
  • Readability guidelines
Session 4

26 September 2024 | 120 mins | 1:00 PM UK

Post approval activities

This session examines post approval regulatory activities, including filing variations, renewals and pharmacovigilance

 Examining filing variations and renewals:

  • Overview of filing variations
  • Requirements and procedures for variations
  • Compare the different types of variations: Type IA, IB and II
  • Variations vs extensions
  • Renewal legislation and procedures

Reviewing pharmacovigilance:

  • Good Pharmacovigilance Practices
  • Understand the pharmacovigilance system
  • Periodic safety update reports (PSURs)
  • Risk Management Plan and Post-Authorisation Safety Studies (PASS)

Practical group work 
Interactive group exercise using the break out rooms. This is designed to cement your knowledge.

Adriaan Fruijtier graduated as a pharmacist at the University of Utrecht, The Netherlands. Since April 2004 he has been an independent regulatory affairs consultant. Until March 2004 he was Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands and has worked as Manager of Regulatory Affairs at Glaxo, also in the Netherlands.

This course is aimed at professionals who want to gain a basic knowledge of regulatory affairs. It would also be applicable to those who work closely with regulatory affairs and would benefit from gaining an overall understanding.

These include:

  • Project Management
  • Quality
  • Product Development
  • Production Personnel
  • Commercial
  • Senior Management
Free First Module and Pricing
  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.


Frequently asked questions (FAQs)

Could your team benefit from this course?


We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Complete our contact form by following the link. Get in touch.


• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate

7 reviews for

Understanding EU Regulatory Affairs

23 September 2024 | 1 Week Live Online Course

  1. MAE Holding (verified owner)


  2. Individual Booking (verified owner)


  3. Takeda

    All the sessions were very helpfull and supportive. The moderation and training leading were excellent and profound.

  4. Norameda


  5. Syneos Health (verified owner)

    A very helpful and comprehensive course that covered core regulatory requirements across the product lifecycle. Ideal for those who need a good overview of all EMA interactions and core requirements.

  6. EBMT (verified owner)


  7. AIM (verified owner)

    The course was well structured, the lector Sophie was extremely professional, friendly and presented well the material. Educo support team and host were very responsive and easily approachable! Overall add-value course to follow.

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