Regulatory Affairs Strategies During Development

Dates in 2025 | Register Your Interest

(1 customer review)

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Develop and execute a regulatory strategy aligned with your organisation’s goals

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Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.

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Course Overview

 

During the early stages of development, it is critical to have a strategic mindset to ensure you make the best regulatory and business decisions. Regulatory professionals must be aware of the many requirements, challenges, and routes to market that are applicable to their products.

This course aims to assist you in choosing the optimal registration strategy for your product based on the product type, indication, and your company’s objectives. You will explore your role during the clinical and CMC phases of development and in preparation for MAA. Additionally, you will examine specific guidelines that will direct your early phase strategy such as ATMP, orphan designation, oncology, and paediatric. By the end of this course, you will have the necessary skills and confidence to navigate towards fast approval, which can translate to significant cost savings.

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.

Course Dates

 

Find out when this course is running so you can plan your training.

2025 Dates TBC

1 Week Live Online Training
Register at the top of the page.

Key Learning Objectives

 

  • Learn how to think strategically throughout the development phases from clinical to manufacturing through to post approval
  • Discover how to implement a global regulatory strategy with a focus on the EU and US procedures
  • Develop successful strategies specific to your therapeutic product including small molecules, biologics, vaccines, biosimilars and cell & gene therapies
  • Learn best practices when working with Regulators and discover how to negotiate and respond to Regulators’ questions successfully
  • Collect and present key information for the submission dossier to achieve a winning strategy

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

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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TBD | 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.

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Session 1

TBD

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

TBD

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

TBD

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

TBD

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

TBD

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.

This course is relevant for regulatory professionals working on early-stage development of products. It is ideal for those currently planning and developing a regulatory strategy.

  • Regulatory Affairs Specialist
  • Regional Coordinator
  • Regulatory Affairs Associate
  • Development Pharmacist
  • Pharmacovigilance Manager
  • Regulatory Affairs Attorney
  • Regulatory Affairs Executive
  • Project Managers
  • Regulatory Affairs Manager
  • Strategy Management
  • Regulatory Affairs Officer
  • Quality Manager
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.

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.

*

• 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

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Regulatory Affairs Strategies During Development

Dates in 2025 | Register Your Interest

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