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Overcoming Regulatory and Quality Concerns for Cell and Gene Therapies

14 & 15 June 2023 | Hybrid Training | London

£895.00£1,295.00

The price is for 2-days | Register for Module 1-Free

Learn to navigate the regulatory and quality landscape for CGTs/ATMPs.

 

 

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Enrol Before | 28 April to Save £400 | 19 May To Save £200

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Course Overview

 

Cell and Gene Therapies (CGT) or ATMPs provide cutting edge treatments for diseases that were once impossible to overcome. Due to their complexity, the quality and regulatory requirements are difficult to interpret and follow. Regulatory agencies require specific quality data for clinical approval and full market approval making the role of regulatory professional a difficult one.

 

This training course will provide you with a complete understanding of the regulatory and quality requirements for cell and gene therapies in the EU and US. Once completed, you will know the regulatory requirements and quality data required in clinical applications and the Common Technical Document (CTD). With a complete understanding of the regulatory routes to market in the EMA and FDA, you will have the confidence to devise a regulatory strategy for your CGT product.

 

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 both online and classroom training courses. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.

What is Included in a Classroom Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Refreshments and lunch provided on each day
  • 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
  • Access to the Educo Life Sciences Training Portal before and after the course for additional learning materials

What is a Hybrid Training Course?

 

You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.

 

We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.

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.

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

Key Learning Objectives

 

  • Understand the regulatory guidelines and processes in Europe and the US for cell and gene therapy products (ATMPs)
  • Learn how to overcome the many quality concerns and challenges that ATMPs present and ensure positive regulatory outcomes
  • Discover the practical challenges of manufacturing cell and gene therapeutics and appreciate the GMP requirements
  • Navigate the regulatory landscape and strategically evaluate possible approval routes for your product to ensure fast approvals
  • Understand what level of information is required in the Common Technical Document ahead of submission.
  • Gain the practical skills to navigate the EMA processes and guidelines including IMPD, PRIME, orphan designation and regulation 1394/2007
  • Manage the US FDA processes and guidelines including IND, OTAT, RMAT

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Hybird Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For classroom attendees, refreshments are served from 8:30 AM. For online attendees, you will receive joining instructions. 

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 subsequent questions and challenges
Introductory Online Module
FREE to Attend | Live & Recorded

21 April 2023 | 1:00 PM (UK)

Delivered Online

Overview of ATMPs and the course

  • Introduction to the course
  • Overview of the topic area and the regulatory/quality challenges of ATMPs

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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Day 1

14 June 2023

Overview of ATMPs, biologics and the development process

  • Learn the key difference between Cell and Gene Therapies (CGTs), biologics and small molecules
  • Overview of a typical development process for ATMPs and biologics
  • Focus on the key documentation from a quality and regulatory perspective

General Introduction to Cell and Gene Therapies and the regulatory processes

  • What is an ATMP/CGT
  • Definition of ATMPs and associated terms
  • Classification of ATMPs – Regulatory decision-making process
  • Overview of the regulatory processes within the FDA and EMA from development through to submission
  • The BLA / MAA and the CTD documentation required
  • Understanding device registration (CE mark for machinery) and product registration

Regulatory strategies for Cell & Gene Therapies or ATMPs

  • Examine the various strategies to achieve regulatory approval for your advanced therapy
  • Certification of ATMPs in EU
  • Scientific advice – Meeting regulators
  • Understanding the risk based approach
  • Discover how the orphan designation works
  • Review of EU regulations for ATMPs – Analysis of regulation 1394/2007
  • Review of US FDA regulations for cell and gene therapies
  • Examining critical EU EMA and US FDA guidance
  • Consideration of factors outside standard ATMPs – combination products and borderline cases

Insight into global regulatory expectations for ATMPs

Insight into global regulatory expectations for ATMPs

  • Examine US FDA regulatory requirements
  • Learn how best to work with the Office of Tissue & Advanced Therapies (OTAT)
  • Understand how to interact with the Regenerative Medicine Advanced Therapy Designation (RMAT)
  • Examine EU system and scientific advice
  • Understand the EU Priority Medicines scheme (PRIME)
  • Understand GMP requirements at Phase I in the US and Europe and the impact for your product
  • Practical insight into other markets

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Day 2

15 June 2023

Clinical trials and investigational medicinal product application for ATMPs

  • Optimising materials for regulatory compliance – vendor qualification
  • Summary of Clinical Trial Application (CTA) requirements
  • The Investigational New Drug (IND) and Investigational Medical Product Dossier (IMPD)
  • Building the IND into the Common Technical Document (CTD)
  • Phases – when and why
  • Risk analysis for biological materials

Overcoming quality challenges for Cell & Gene Therapies – Part 1

  • Overview of frequent quality concerns,
  • Introduction to the ATMP equation
  • What is enough data to release? The issues Qualified Persons face with cell and gene therapies
  • What quality data is required when creating the clinical trial applications (CTA/IND) and for regulatory submission in the dossier (CTD)

Overcoming quality challenges for Cell & Gene Therapies – Part 2

  • Using the Quality Target Product Profile (QTPP)
  • Examining the Critical Quality Attributes (CQAs) and Critical Material Attributes (CMAs)
  • Discussing the Key linkage in your dossier
  • Reviewing the control strategy
  • Understanding the risk-based approach
  • Reviewing sourcing materials

The CTD quality aspects for Cell and Gene Therapies

  • Understand the data expectations for ATMPs
  • Review the sections of the CTD
  • Using QTPP, CQAs and Critical Process Parameters (CPP) / CMAs
  • Linking the control Strategy

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Andrew Willis is a regulatory and development consultant with 35 years of experience. His management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

 

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

 

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. More recently for IO Biotech, Andrew was SVP of Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place.

 

He currently delivers extensive training courses in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.

This course is aimed at professionals who work in regulatory affairs on Cell and Gene Therapy (ATMP) products. These include:

  • Regulatory Affairs Professionals
  • CMC Regulatory Professionals
  • Product Registration Personnel
  • Project Managers in Regulatory Affairs
  • Compliance Managers
  • Documentation Specialists
  • Quality Professionals and QPs.

 

It is also aimed at those who require a complete guide to Cell and Gene development challenges. These include:

  • Management
  • Professionals moving into the CGT
  • Clinical Trial Professionals
  • Manufacturing Professionals.

Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.

 

The course is held in the following venue:
Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

 

Link to the Google Map

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

 

**Dates and times are subject to change**

Introductory Module 1
FREE | Recorded | Optional

Sign up

Overview of ATMPs and the course

  • Introduction to the course
  • Overview of the topic area and the regulatory/quality challenges of ATMPs

Register for Module 1 | Free

Complete the form below and you will be sent the recording of the session.

Module 2

25 April (AM) | 120 mins  | 10 AM UK

Overview of ATMPs, biologics and the development process

  • Learn the key difference between Cell and Gene Therapies (CGTs), biologics and small molecules
  • Overview of a typical development process for ATMPs and biologics
  • Focus on the key documentation from a quality and regulatory perspective

 

 

General Introduction to Cell and Gene Therapies and the regulatory processes

  • What is an ATMP/CGT
  • Definition of ATMPs and associated terms
  • Classification of ATMPs – Regulatory decision-making process
  • Overview of the regulatory processes within the FDA and EMA from development through to submission
  • The BLA / MAA and the CTD documentation required
  • Understanding device registration (CE mark for machinery) and product registration
Module 3

25 April (PM) | 120 mins | 1 PM UK

Regulatory strategies for Cell & Gene Therapies or ATMPs

  • Examine the various strategies to achieve regulatory approval for your advanced therapy
  • Certification of ATMPs in EU
  • Scientific advice – Meeting regulators
  • Understanding the risk based approach
  • Discover how the orphan designation works
  • Review of EU regulations for ATMPs – Analysis of regulation 1394/2007
  • Review of US FDA regulations for cell and gene therapies
  • Examining critical EU EMA and US FDA guidance
  • Consideration of factors outside standard ATMPs – combination products and borderline cases
Module 4

26 April (AM) | 120 mins | 10 AM UK

Insight into global regulatory expectations for ATMPs

Insight into global regulatory expectations for ATMPs

  • Examine US FDA regulatory requirements
  • Learn how best to work with the Office of Tissue & Advanced Therapies (OTAT)
  • Understand how to interact with the Regenerative Medicine Advanced Therapy Designation (RMAT)
  • Examine EU system and scientific advice
  • Understand the EU Priority Medicines scheme (PRIME)
  • Understand GMP requirements at Phase I in the US and Europe and the impact for your product
  • Practical insight into other markets
Module 5

26 April  (PM) | 120 mins | 1 PM UK

Clinical trials and investigational medicinal product application for ATMPs

  • Optimising materials for regulatory compliance – vendor qualification
  • Summary of Clinical Trial Application (CTA) requirements
  • The Investigational New Drug (IND) and Investigational Medical Product Dossier (IMPD)
  • Building the IND into the Common Technical Document (CTD)
  • Phases – when and why
  • Risk analysis for biological materials
Module 6

27 April (AM) | 120 mins | 10 AM UK

Overcoming quality challenges for Cell & Gene Therapies – Part 1

  • Overview of frequent quality concerns,
  • Introduction to the ATMP equation
  • What is enough data to release? The issues Qualified Persons face with cell and gene therapies
  • What quality data is required when creating the clinical trial applications (CTA/IND) and for regulatory submission in the dossier (CTD)
Module 7

27 April  (PM) | 120 mins | 1 PM UK

Overcoming quality challenges for Cell & Gene Therapies – Part 2

  • Using the Quality Target Product Profile (QTPP)
  • Examining the Critical Quality Attributes (CQAs) and Critical Material Attributes (CMAs)
  • Discussing the Key linkage in your dossier
  • Reviewing the control strategy
  • Understanding the risk-based approach
  • Reviewing sourcing materials
Module 8

28 April (AM) | 120 mins | 10 AM UK

The CTD quality aspects for Cell and Gene Therapies

  • Understand the data expectations for ATMPs
  • Review the sections of the CTD
  • Using QTPP, CQAs and Critical Process Parameters (CPP) / CMAs
  • Linking the control Strategy

 

Delivered by San Salvator training experts.

 

This course is aimed at professionals who work in regulatory affairs on Cell and Gene Therapy (ATMP) products. These include: Regulatory Affairs Professionals | CMC Regulatory Professionals | Product Registration Personnel | Project Managers in Regulatory Affairs | Compliance Managers | Documentation Specialists | Quality Professionals and QPs.

 

It is also aimed at those who require a complete guide to Cell and Gene development challenges. These include: Management | Professionals moving into the CGT | Clinical Trial Professionals | Manufacturing Professionals.

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.

*

• 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.