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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.
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.
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
Sign up
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.
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.
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.
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.
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
The online module is free to attend on this course. When you register you will have full access to the live session, recording and presentation slides.
To learn more about what is covered in the module and when it is, follow the link below.
