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

26 September 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.

Day 1

14 November 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 November 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.