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.
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
- 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.
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 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.
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.
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