0
  • No products in the cart.
Total:€0
Sale
Regulatory Due Diligence for CTD Module 3: Strengthening CMC Dossier Submissions
, ,

Regulatory Due Diligence for CTD Module 3: Strengthening CMC Dossier Submissions

10 June 2026 | 1-Day Live Online Course

Original price was: €696.Current price is: €557.

Gain the tools to critically review CTD Module 3, identify CMC dossier gaps, and strengthen submissions for regulatory success

Register Early To Save

 

Enrol before 15 May to save 20% (June Course)

Discount has been applied to the price above. VAT, if applicable, will be added.

Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Regulatory due diligence is a critical step in the success of product submissions and licensing activities. Regulators expect dossiers that are comprehensive, compliant, and internally consistent. Overlooking deficiencies in Module 3 (CMC), misunderstanding regional differences, or failing to link CQAs and CPPs to product performance can result in delays, refusals, or post-approval risks.

 

This course provides a practical, hands-on approach to regulatory due diligence for CTD/eCTD submissions. Participants will learn how to critically assess dossiers, apply structured frameworks (CQA Pyramid, CTD Equation), and anticipate regulator concerns. The training integrates drug substance, drug product, and combination product considerations, while highlighting regional differences between EU and US expectations. Case studies and interactive exercises ensure practical application of the tools and checklists shared.

 

Learn more about how we deliver live online training.

Download the Agenda

 

You can view the agenda by scrolling down on this page. If you would like to receive a PDF version with all the course information, please complete the form below.

 

By clicking submit, you agree to our Privacy Policy

Key Learning Objectives

 

  • Define regulatory due diligence in legal, business, and regulatory contexts
  • Apply the CQA Pyramid and CTD Equation to identify dossier deficiencies
  • Review Module 3 (Drug Substance and Drug Product) in detail, including CEP/EDMF/DMF routes
  • Recognise common pitfalls in specifications, stability, control strategies, and data integrity
  • Assess device elements in drug–device combinations (Article 117 MDR, NBOp, usability)
  • Compare EU and US expectations for submissions and identify regional nuances
  • Apply due diligence in practice with hands-on assessments of product dossiers using real-world case studies
  • Use structured checklists to support practical due diligence reviews

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

10 June 2026

1-Day Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

Course Information

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules

10 June 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

180 mins | 9:30 AM UK

Introduction & What is Regulatory Due Diligence?

  • Legal, business, and regulatory perspectives
  • In-licensing vs in-house development
  • Development timelines (PSC Levels 0–3)

 

Regulatory Due Diligence for New Submissions

  • CTD/eCTD requirements and pitfalls
  • Using the CQA Pyramid and CTD Equation
  • CTD Module structure, Module 3 as “house of cards”
  • QbD and Control Strategy linkages

 

Tools and Techniques for Due Diligence

  • Gap analysis, compliance checklists
  • Linking CQAs, CPPs, QTPPs across the CTD
  • Case examples of common dossier deficiencies
Session 2

180 mins | 1:30 PM UK

Drug Substance & Drug Product Due Diligence (Module 3 focus)

  • Drug substance (S.1–S.7): manufacturing, impurities, CEP/EDMF/DMF routes, reference standards, stability
  • Drug product (P.1–P.8): formulation, manufacturing, control strategy, packaging, stability
  • Specifications: ICH Q6A/B → Q6(R1) updates

 

Combination Products & Device Elements

  • Article 117 MDR and NB Opinions
  • Usability/human factors, compatibility studies
  • Container closure and extractables/leachables

 

Regional Differences (EU vs US)

  • Key divergences in dossier expectations
  • FDA vs EMA approaches to data, validation, stability

 

Practical Workshop & Case Studies

  • Hands-on dossier assessment: identifying gaps, risks, and regulator red flags
  • Applying checklists to product examples

 

Wrap-Up & Takeaways

  • Due diligence checklists for practice
  • Final Q&A
Andrew Willis - Educo Trainer

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 suitable for professionals working in:

  • Regulatory Affairs and CMC Regulatory Writing
  • Quality Assurance and Compliance
  • CMC Development and Technical Teams
  • Project and Submission Managers
  • Anyone involved in preparing, reviewing, or auditing product dossiers

On-Demand Access

Can’t wait for the next course date?

Get instant access to the training materials by selecting ‘On-Demand’ from the drop-down menu above. Start learning at your convenience. You’ll also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.

Reviews

There are no reviews yet.

Be the first to review “

Regulatory Due Diligence for CTD Module 3: Strengthening CMC Dossier Submissions

10 June 2026 | 1-Day Live Online Course

”

Your email address will not be published. Required fields are marked *

Categories: , ,

You may also like…

Related products

  • Read more
  • Select options This product has multiple variants. The options may be chosen on the product page
  • Read more
Select Your Currency
GBP Pound sterling
EUR Euro
USD United States (US) dollar