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

Sign up

8 February 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.

 

Module 2

11 March 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

Module 3

12 March 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.

Module 4

13 March 2024 | 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

13 March 2024 | 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

14 March 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.

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.