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Completing the Quality/CMC Module of the CTD

19 & 20 April 2023 | Hybrid Training | London

£895.00£1,195.00

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

Master the quality module of the CTD with this comprehensive course

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Enrol Before | 28 February To Save £400 | 28 March To Save £200

Discount is applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,595 and live online is £1,295

Course Overview

 

The quality module of the Common Technical Document (CTD) presents the CMC (Chemistry, Manufacturing and Controls) data in the submission dossier for small and large molecules. Compiling the CMC regulatory material is challenging; however, module 3 must be completed with efficiency and accuracy to gain fast approval.

 

This training course examines the FDA and EMA regulatory requirements for both pharmaceuticals and biotech. It will give you the confidence to identify, compile and submit the correct information in the quality module. Once completed you will have a comprehensive understanding of key areas such as CMC regulatory strategy, building the pharmaceutical sections, creating the drug product sections, and creating the Quality Overall Summary (QOS).

 

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. 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 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

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.

Key Learning Objectives

 

  • Navigate the CMC quality module for both small molecules and biotech (large molecules)
  • Understand the regulatory requirements from the reviewers perspective to ensure you include adequate data and justifications.
  • Create CMC regulatory strategies to ensure speedy submissions and approvals
  • Learn how to compile the pharmaceutical sections of the CTD, specifically examining the information required CQAs, CPP and PAT.
  • Learn how to build the drug product sections of the dossier (P1 to P8), with a case study example on P5 – control of drug product
  • Discuss and understand that different data levels are required for different product types
  • Gain the skills to compile the Quality Overall Summary (QOS) ready for submission.

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

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

Hybrid 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 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.

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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.

This course is aimed at professionals who work in regulatory affairs and contribute to the building of the submission of the dossier. These include: Regulatory Affairs Professionals

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

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?)

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

29 April | 60 mins | 1:00PM UK

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
Module 1 & 2

17 May | 2 sessions | 120 mins each | 9.30am and 12.30pm UK

Overview of the CTD Global Dossier

  • Understanding the differences between small and large molecules in the CTD
  • Defining the Quality Target Product Profile (QTPP)
  • Examining key terminology with in the CTD global dossier
  • Overview of CMC linkage

 

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
Module 3

18 May | 2 sessions | 120 mins each | 9.30am and 12.30pm UK

Building the pharmaceutical sections of the dossier – part 1

  • 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

 

Building the pharmaceutical sections of the dossier – part 2

  • 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
Module 4

19 May | 2 sessions | 120 mins each | 9.30am and 12.30pm UK

Examining the drug product sections of the dossier – part 1

  • 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

 

Examining the drug product sections of the dossier – part 2

  • 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
Module 5 and 6

20 May | 2 sessions | 120 mins each | 9.30am and 12.30pm UK

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 and the impact of your dossier
  • Global dossier roll out
  • Practical exercise on change control

Delivered by San Salvator training experts.

This course is aimed at professionals who work in regulatory affairs and contribute to the building of the submission of the dossier. These include: Regulatory Affairs Professionals

  • CMC Regulatory Professionals
  • Product Registration Personnel
  • Project Managers in Regulatory Affairs
  • Compliance Managers
  • Documentation Specialists
  • Quality Professionals and QPs
Free Online 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.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.