Marketing Authorization Holder (MAH), Regulatory Affairs and Qualified Person: responsibilities and interactions for GMP compliance
- 1° EDITION: December 4th 2024
- 2° EDITION: June 4th 2025
- Online
-
Italian
- 1° EDITION: December 4th 2024
- 2° EDITION: June 4th 2025
- Online
-
-
Italiano
-
Training overview
European legislation places increasing emphasis on the responsibilities of the Marketing Authorization Holder (MAH) in ensuring compliance with the standards required by the European Union, a requirement that underpins the assurance and integrity of the data supporting the marketing authorization; in addition, the MAH also has a key role in facilitating GMP Compliance.
The training course “Marketing Authorization Holder (MAH), Regulatory Affairs and Qualified Person: responsibilities and interactions for GMP Compliance,” focuses precisely on delving into the responsibilities of the Marketing Authorization Holder and the interactions between them and the Regulatory Affairs and Qualified Person, aimed at ensuring the company’s compliance with current requirements through an up-to-date, effective and GMP/GDP-compliant Pharmaceutical Quality System and adherence to legislation.
The lecturers, regulatory and GMP experts, will provide their expertise to provide the key elements and knowledge, which today must necessarily be part of the competencies of these professionals, in order to fully understand the roles and responsibilities of the different figures involved and how they cooperate for the maintenance of the marketing authorization of the drug.
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
- Role and Responsibilities of the MAH in the GMP Context
- Role and responsibilities of the QP and production site regulatory & compliance
- The relationships and interfaces for communication and sharing among the functions involved
- The relevant parts and requirements of GMP and applicable legislation
- How to maintain evidence of compliance
09:00 – 13:00 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
- QP and its key role
- GMP areas between QP and MAH
- Production and regulatory issues
- Regulatory and its key role
- Areas and activities at the interface between Regulatory and MAH
- Regulatory practices and issues in the manufacturing context
Personnel involved in Regulatory Affairs, Quality Assurance and Qualified Person sectors.
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
Laura Bisi
Regulatory Affairs and Quality Director – Thea Farma
She graduated in Chemistry from the University of Milan in 2001, in 2002 she joined the Pharmacy division of the Bracco Italian Regulatory Authority as an assistant. After some profitable experiences in leading companies in the sector, since 2013 she has been Director of Regulatory Affairs (Italy and Abroad) and Quality Director of Thea Farma, the Italian branch of Laboratoires Thea.
Leonardo Gabrieli
Pharmaceutical Consultant, former Quality & Regulatory Director Teva Italia
He has thirty years of experience in the pharmaceutical sector, with responsibility in Production, Quality Control, Quality Assurance and as a Qualified Person in companies multinational, productive and commercial. He has delved into all the elements involved in the manufacture and control of medicines, with particular attention to the requirements of the GMP/GDP directives, laws and guidelines, issued in the international pharmaceutical sector. He has participated as an expert in various Courses, Symposia and University Masters, provided multiple training events on GMP/GDP and carried out business consultancy for the verification and setting up of an effective Pharmaceutical Quality System. In possession of the qualifications of Quality System Manager and Quality Auditor, he has carried out hundreds of inspections on behalf of a Certification body for assessments of compliance with ISO 9001 standards and Notification for Medical Devices. He collaborates with AFI in the implementation of the annual Meeting of Qualified Persons.
Register now
850€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
You may also be interested in...
- 8 May 2024
- Online
- 20 May 2024
- Online
- 21 May 2024
- Online
- 22 May2024
- Online
- 27-28 May 2024
- Online
- June 11th 2024
- Online
- 12 June 2024
- Online
- September 27th & October 4th 2024
- February 21st and 28th 2025
- Online
- October 1stand 2nd 2024
- February 18th and 19th 2025
- Online
During the training course "Medical Device Regulatory Affairs", key issues for those who want to operate or work in this [...]
- 10 October 2024
- 13 March 2025
- Online
- 13-14 November 2024
- 8-9 May 2025
- Online
- 13 December 2024
- 16 May 2025
- Online