Common Technical Document (CTD) module 3: focus on the most critical aspects

  • 1° EDITION: 2 December 2024
  • 2° EDITION: 5 June 2025
  • Online
  • Italian

Training overview

Pharma Education Center organizes the training course “Common Technical Document (CTD) module 3: focus on the most critical aspects” a day of in-depth study on the key points of the CTD Module 3 of synthetic drugs for human use. The main technical-regulatory issues encountered during the preparation and approval of the drug quality dossier will be examined and discussed, also in the light of the experience gained at the Italian drug agency (AIFA), and useful information and suggestions will be passed on to delegates, to help them consolidate a dossier effectively.

Key points of the training

  • Regulatory aspects
  • Major shortcomings found in the review and approval of dossiers of chemically synthesized drugs for human use
  • Module 3 drafting: discussion of some critical points (Active Substance and Finished Drug)

09:30 – 12:30 MORNING SESSION


Production Process

  • Critical Steps, Intermediate, Bulk
  • Process validation: review of EMA guideline
  • Standard vs non-standard process definition: reference legislation
  • Sterilization of actives, finished products, containers: reference legislation


  • Definitions of shelf-life and re-test period
  • How to define specifications
  • Formal stability, in-use, thermal cycling, stress study
  • Other guidelines (e.g., stability to support variations)


  • ICHQ3A
  • ICHQ3B
  • ICHQ3C and EMA guideline residual solvents
  • Hints at ICHQ3D and ICHM7

Professionals involved in the pharmaceutical sector: Regulatory Affairs, Development Documentation, QA & Regulatory Compliance, Research and Development.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Raffaella Pandini

Raffaella Pandini

Regulatory Affairs Director presso Pharma D&S

Register now

Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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