Enrol Before | 18 August To Save £400 | 20 September To Save £200
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,495 and live online is £1,395
Completing the Quality/CMC Module of the CTD
18 & 19 October 2023 | Live Online Training
£1,395.00
The price is for 2 days | Register for Module 1-Free
Master the quality module of the CTD with this comprehensive course
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
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 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.
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.
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
23 August 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
18 October 2023
What is the CTD?
- Understanding the Key aspects of the CTD Global Dossier
- What is a QTPP
- Key Terminology
- Examining the structure and content of the CMC Sections – developing a CTD Roadmap
- CMC Linkage
Understanding and reviewing the drug substance sections of the CTD dossier
- 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
- Certificate of Suitability (CEP)
- ASMF (EU)
- DMF (US)
- Examine the linkage to the Drug Product Section
- Examine the essential information required from API suppliers
- Examine some basic rules for Q11 development and manufacture of drug substances
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 CTD dossier – The criticality of development
- 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
19 October 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 reviewer’s 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
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
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
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.
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. |
|---|
Centrient (verified owner) –
n/a
Zyeco (verified owner) –
n/a
Owl Pharma (verified owner) –
n/a
Janssen Biologics (verified owner) –
What I enjoyed most from this training was the continuous interaction between the trainer and trainees. Even though this training was fully online, it was very practical, queries were addressed along the presentations. The fact that we were a small group created a safe environment where everybody was empowered to ask and debate anything.
Individual Booking (verified owner) –
n/a
Fresenius Kabi –
n/a
Martindale Pharma –
n/a
Asphalion –
Now, I understand the logic behind the CTD construction/writing and I gained the confidence at the time an eventual letter of deficiency is received.
Tiofarma –
n/a
The Reg Consultants –
n/a
Emmes (verified owner) –
n/a
BioVersys (verified owner) –
n/a
Thermo Fisher (verified owner) –
With over 10 years of industry experience, I have participated in numerous multi-day trainings. This particular one was exceptionally engaging, as the trainer’s energy level was just right to keep me focused on the material without feeling fatigued.
IMZ KFT –
n/a
Fresenius Kabi –
n/a
Union Therapeutics (verified owner) –
n/a
Sever Pharma Solutions –
The online course was great. The high level of competence in the area of the course leader and the professionality of the attendants drove the course into the main subject and rewarding discussions.