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Understanding EU Regulatory Affairs

14 March 2023 | 1 Week Live Online Course

£795.00

The price is for all 6 Modules Register for Module 1-Free

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

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Enrol before | 10 February to save £400 | 3 March to save £200

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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 on 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.

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 week after the course (online) providing you with extra time with the trainer
  • A validated certificate of attendance available for you to download

Learn more about how we deliver live online training

 

Register For Free Online Session

 

There are limited spaces on the introductory session. 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.

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

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

Post Learning Implementation Plan (PLIP)

Pre-course

  • 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 February 2023 | 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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Module 2

14 March 2023 | 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

 

Module 3

15 March 2023 | 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.

Module 4

16 March 2023 | 60 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
Module 5

16 March 2023 | 60 mins | 2:00 PM UK

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
Module 6

17 March 2023 | 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.

Sophie Nageotte is a Regulatory and CMC expert with over 20 years of experience within the pharmaceutical industry. She gained her Master’s degree in analytical chemistry from Manchester University and her Chemical Engineer degree from Montpellier School of Chemistry. She went on to work in pharmaceutical development and post-marketing CMC regulatory compliance in companies such as Bayer, Stragen, PregLem and Laboratoires Galderma.

 

She now runs her own consultancy, delivering consultancy and support in writing IMPDs, CTD Module 3 and QOS, preparing variations and answering questions from health authorities.

 

Alongside this she is a regular trainer on topics around regulatory affairs including module 3 of the CTD and global regulatory compliance strategies. She has delivered many courses on EU regulatory affairs basics supporting delegates understand the EU regulatory processes during the drug product lifecycle. Sophie is an engaging trainer who brings examples and solutions with her whilst fostering a discussion led class.

 

Get to know Sophie by watching an interview with her where she discusses training.

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
  • 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.

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ADDITIONAL INFORMATION

• 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