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.
Sei interessato ai corsi sugli Affari Regolatori?
Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*. You may choose from these trainings:
- Impact of variations on the site regulatory and compliance activities
- Preclinical studies in drug registration: focus on toxicology guidelines and CTD structure
- Skilful drafting of technical documentation
- Drugs registration requirements in extra-EU countries
- Basic training in Regulatory Affairs
- Common Technical Document (CTD) module 3: focus on the most critical aspects
- Marketing Authorization Holder (MAH), Regulatory Affairs and Qualified Person: responsibilities and interactions for GMP compliance
(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.
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
- 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)
- 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.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting email@example.com. 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.
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.
Team Leader/Senior Project Manager Affari Regolatori at Pharma D&S
Graduated in Chemistry and Pharmaceutical Technologies in 2004 at the University of Florence, Stefano Nepi began working in the same year at Menarini in the Analytical Research department, dealing with stability studies, control of raw materials and finished products and analytical validations. After completing his PhD in Structural Biology in 2009, he began working with Pharma D&S in the Regulatory Affairs department. He has been involved in the development of module 3, analytical development and national and international regulatory strategy for Pharma D&S for about 10 years. Since May 2019 he has been Team Leader of the Regulatory Affairs department of the Florence office of Pharma D&S.
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