Live Online Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. 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 and subsequent questions and challenges

Introductory Online Module

FREE to Attend | Live & Recorded

24 February 2023 | 60 mins | 1:00 PM UK

Delivered Online

Overview of the CMC Regulatory Affairs Course

• Introduction to the course
• Understanding the Key aspects of the CTD Global Dossier
• Examining the role and importance of the quality module of the CTD

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

19 April 2023

Understanding key CMC aspects of the CTD such as the drug substance section

• Examining the structure and content of the CMC Sections – developing a CTD Roadmap
• Overview of the Drug Substance Sections for small molecules and biologics
• Review drug substance sections including from S.1 to S.7 including manufacture, characterisation, control of drug substance, reference standards, stability.
• EU and US Drug Master Files (DMFs) explained
• Examine the linkage to the Drug Product Section
• Examine some basic rules for Q11 development and manufacture of drug substances

Structure and Content of the CMC Sections of Active Substance

• Structure and Content of the CMC Sections – CTD Roadmap
• Introduction to Drug Substance Sections for Small Molecules and Biologics
• Presentation of different DS related reference documents (ASMF, CEP)
• GMP Requirements of active substance
• Tips: Essential information required from API suppliers
• How to present CMC Sections with optimum level of detail to minimize variations

Exercise

Interactive group exercises are also included as part of the course to cement your knowledge on the various different CMC aspects of the CTD.

Building the pharmaceutical sections of the dossier

• Examining the importance of development pharmaceutics
• Review of the sections on development pharmaceutics
• Understanding the reviewer’s perspective, highlighting methods to ensure we answer the reviewer’s questions
• Examine CMC linkage
• Explanation of Critical Quality Attributes (CQA)
• Discuss Critical Process Parameters (CPP)
• Process analytical technology (PAT) explained

Day 2

20 April 2023

Examining the drug product sections of the dossier 

A significant proportion of time will be spent on the drug product sections of the dossier.

• Overview of drug product sections of the dossier
• Review of section 3.2.P of the CTD, specifically examining P.1 to P.8
  • Specifically examine section 3.2.P.5 Control of Drug Product
  • Using analytical data you will demonstrate linkage and reviewer expectations.
  • It highlights the need for writing great justifications.
• Examine the key aspects for 3.2.R and 3.2.A sections
• Discuss and understand the differences in data levels required for different product types

Exercise

Interactive group exercises are also included as part of the course to cement your knowledge on drug product sections of module 3.

Understanding the Reviewers Perspective – The CTD Equation and Importance of Development Pharmaceutics

• The equation of Drug Product CTD Section
• Data requirements for drug product development for different types of products
• Scale-up and technical transfer
• CMC Linkage

Understanding source documents

• Overview of source documents
• Understanding the reviewer’s perspective (Using analytical data as an example)
• Highlight the needs of internal teams versus external reviewers
• The Quality Overall Summary (QOS)
• Reviewers questions to be answered

Change control and global roll out

• Change control management and the impact of your dossier
• Global Dossier Roll Out for ROW countries
• Practical exercise on change control
• Regulatory Strategy on global lifecycle management
• Structure global & local submission teams to ensure compliance
• Final tips on global dossier writing and management

Exercise

Interactive group exercises are also included as part of the course to cement your knowledge on global roll out of module 3.

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.