Regulatory Affairs department plays a key role within pharmaceutical companies, interfacing with various business functions on a daily basis. Our Regulatory Affairs training course is dedicated to those who need to have an overview of this area because they are approaching a career in regulatory affairs or belong to other areas and need to improve their knowledge.
In fact, the purpose of the training course “Basic training in Regulatory Affairs” is to provide the fundamentals of key regulatory issues such as the preparation of the Quality Module and the procedural aspects governing the maintenance of the drug lifecycle.
ARE YOU INTERESTED IN REGULATORY AFFAIRS TRAININGS?
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
- La registrazione di un farmaco: focus sulle linee guida di tossicologia e struttura CTD per la sezione preclinica
- 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
- Module I - CTD: understand and prepare the quality section (module 3)
- Module II - regulatory aspects of the lifecycle of a drug
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
DAY 1 – Module I – CTD: understanding and preparing the Quality section (Module 3)
A) Regulatory References and Structure of CTD
- Regulatory agencies and ICH
- Structure of the CTD
- Documentary Setup of the CTD
B) Section 3.2.S “Drug substance”
- ASMF and CEP
- Review of the entire section
C) Section 3.2.P “Drug product”
- Review of the entire section
DAY 2 – Module II – Regulatory Aspects of the Lifecycle of a Drug
A) Drug registration procedures and variations
- Main legal and regulatory aspects
- Reference authorities in Italy and Europe – regulatory references
- Legal Basis
- The registration dossier according to product type and legal basis
- Overview of registration procedures (centralized, mutual recognition, decentralized, national)
B) Lifecycle Management
- Line extension
- Lifecycle: The EU variations regulation 712/2012
- Type I and Type II variations
- Preparation of a variation (cover letter,application form, front end, POL payment
- Printed matter: package leaflets, rcp, labels – QRD template – Procedures related to printed variations
- Disposal of stock and Farmastampati
- AIC renewals
- Sunset clause
Professionals involved in the pharmaceutical sector: Regulatory Affairs, Development Documentation, QA & Regulatory Compliance, Research & Development, Pharmacovigilance.
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 email@example.com 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 firstname.lastname@example.org. 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.
Regulatory Affairs Director at Pharma D&S
Graduated in 1997 in Pharmaceutical Chemistry and Technologies at the University of Milan, she gained professional experience in pharmaceutical companies and in the world of pharmaceutical consultancy. Pandini began her career in the regulatory affairs of Rottapharm srl and subsequently worked as RA Senior Officer at Zambon Group SPA. Since 2006 she has been Regulatory Affairs Director at PHARMA D&S and she is also involved in training activities within the Pharma Education Center.
Regulatory Affairs Senior Project Manager 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.
Prices are for the entire training session; when purchasing individual days, the price will be reduced.
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