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

5 March 2025 | 60 mins | 1:00 PM UK

The role of regulatory affairs during development

• An Overview of Regulatory Affairs and European / US Legislation
• Understanding where we interact during the development cycle
• Provision of strategy and guidance (how to use guidance)
• Project and product management – the interface
• Role within the organisation

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

7 April 2025 | 150 mins | 1:00 PM (UK time)

Introduction to regulatory strategy and regulatory plans

This session will provide insight, with practical examples, on the issues surrounding new drug development, principally as seen from a regulatory perspective.

• Review regulatory timelines
• Examine regulatory plans and the content of them
• Competitors
• Regulatory environment

Session 2

8 April 2025 | 150 mins | 1:00 PM (UK time)

Key considerations and challenges as your ‘product’ progresses through development

This session will provide valuable insight into various processes and challenges that you will face during product development such as scientific advice and pricing and reimbursement considerations.

Pricing and Reimbursement

• Health Technology Assessment (HTA)
• Interactions between EMA and HTA authorities
• National HTA authorities
• Overview of US model

Scientific advice

• Introduction
• Scientific advice at the EMA and FDA
• Scientific advice at National Authorities
• Relationship between scientific advice and approval probability
• Examples of good scientific advice questions

SME status

• Examine SME status and the advantages of gaining SME status
• Requirements to fulfil SME status
• Review the procedure

Session 3

9 April 2025 | 150 mins | 1:00 PM (UK time)

Review of guidelines on specific areas which will inform your regulatory strategy during development – Part 1

This session will examine specific areas that you will need to consider when developing your product. For example, the specific guidelines for oncology products and how orphan drug designation works and its advantages.

Oncology

• Examine why is oncology different?
• Review the specific guidelines

Orphan designation

• Examine the legal background
• Discuss the requirements for orphan designation
• What are the advantages of gaining orphan drug designation?
• Review case study examples
• Procedure
• Guidance

Session 4

10 April 2025 | 120 mins | 1:00 PM (UK time)

Review of guidelines on specific areas which will inform your regulatory strategy during development – Part 2

This session will examine specific areas that you will need to consider when developing your product. For example, the specific guidelines that surround paediatric development and cell and gene therapies (ATMPs in Europe).

Paediatric development

• Paediatric Legislation
• Review of the Paediatric Legislation
• Guidance on the investigation of medicinal products in the paediatric population (ICH E11)
• Other paediatric guidance documents

ATMP

• Definition
• Hospital exemption
• Guidelines

A review of other key areas

• Generic criteria
• Accelerated development processes in the EU and US

Session 5

11 April 2025 | 120 mins | 1:00 PM (UK time)

Progressing through clinical development (Phase I to Phase III)

While developing drugs there are issues, tasks, regulations & procedures that have to be considered as you advance towards the MAA. This session will be an opportunity to work through the following challenges:

• Clinical Development Phase I to III : requirements and applications across the EU
• Reconciling manufacturing, non-clinical and clinical demands within the regulatory framework and commercial imperatives
• Clinical Trial Regulation (CTR)
• IB and IMPD
• GMP aspects
• CTFG and other guidance
• CTIS
• Identify the need for, and timing of, Scientific Advice

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.