Common Technical Document (CTD) module 3: focus on the most critical aspects
- 1° EDITION: 2 December 2024
- 2° EDITION: 5 June 2025
- Online
-
Italian
- 1° EDITION: 2 December 2024
- 2° EDITION: 5 June 2025
- Online
-
-
Italiano
-
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.
Are you interested in Regulatory Affairs training?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- CTD Modulo 3: I Punti Critici
- La Scrittura Efficace dei Documenti Tecnici
- Aspetti Regolatori degli Integratori Alimentari e Novel Food
- Focus sul Modulo 5 del CTD
- Requisiti Registrativi per gli APIs in area extra EU
- La Registrazione di un Farmaco: Linee-Guida di Tossicologia e Struttura CTD per la Sezione Preclinica
- Impatto Regolatorio dei Cambi
- Affari Regolatori: Le Basi dei Regulatory Affairs
- Building a Successful DMF Application Strategy for API, Excipient, and Packaging Material Registration in China – English training
- Marketing Authorization Holder (MAH), Affari Regolatori e Qualified Person: Responsabilità ed Interazioni per la Compliance GMP
- La Gestione delle Elemental Impurities
(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.
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
14:00 – 17:00 AFTERNOON SESSION
Program
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
Stability
- 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)
Impurities
- 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 info@pharmaeducationcenter.it 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 info@pharmaeducationcenter.it. 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.
Speakers
Raffaella Pandini
Regulatory Affairs Director presso Pharma D&S
Register now
850€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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