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

6 February 2025 | 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.

 

Session 1

17 March 2025 | 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

18 March 2025 | 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

19 March 2025 | 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

20 March 2025 | 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.