Discover the course
and Audit in GVP
How to apply Good Pharmacovigilance Practices (GVPs) to Quality Management and Pharmacovigilance Auditing
Quality is an essential requirement in the management of any Pharmacovigilance System, as well as to guarantee their Compliance. The Good Pharmacovigilance Practices (GVPs) are the indications provided by EMA to simplify the management of the pharmacovigilance systems in the European Union. Therefore, the complete and correct knowledge of GVPs is essential to ensure the quality management of the pharmacovigilance systems. The effective evaluation of the risk-benefit ratio and of the patients' well-being is essential to ensure the monitoring of medicine's safety.
This course has aims at sharing the knowledge needed to manage and implement:
- pharmacovigilance inspections.
The know-how necessary to implement and manage the compliance with the GVPs will be discussed, in order to ensure the company's Inspection Readiness. Finally, the management and oversight of external suppliers that could have to be involved for these activities will be reviewed.
During this 2 day training, the following topics will be addressed:
Quality management in Pharmacovigilance: ISO-like model
- The company's quality system
- Key Performance Indicators (KPI)
The Good Pharmacovigilance Practices (GVP): compliance, requirements, and interpretation
Audit planning and management
- Risk analysis
- Audit planning
- Types of Audit (remote vs on-site)
Management of vendors, contracts and Pharmacovigilance Agreement (PVA), oversight
Compliance monitoring and KPIs
Management of Corrective and Preventive Action Plans (CAPA) and deviations in Pharmacovigilance
The Pharmacovigilance System Master File (PSMF)
Management of change in Pharmacovigilance
Questions and answers*
* The final questions and answers are part and parcel of the program: the teacher will answer any question from the participants to clarify their unmet needs.
The course will be in Italian.
With more than 25 years of experience in the Life Sciences, Daniela is currently the Head of QA GCP & GVP in Fidia Farmaceutici SpA, a Pharmaceutical Company with Headquarters in Abano Terme, Padua, Italy.
In her position, she is responsible for ensuring quality and compliance of the GCP and GVP Quality System implemented at Fidia Farmaceutici.
Before joining Fidia, she has been working, as Vice-President Strategic Account Management & Scientific Director, from July 2014 to December 2018, at seQure Life Sciences srl, a niche service provider of Pharmacovigilance, Quality Assurance and Regulatory Compliance Solutions.
Daniela has an extensive experience in leading and managing GxP Quality Systems within the Pharmaceutical Industry having being working in Sigma Tau industrie farmaceutiche riunite S.p.A (now ALFASIGMA SpA) for more than 20 years, with her last Job Position as Head of Corporate R&D Quality Assurance and her main responsibilities for ensuring:
- Regulatory Compliance
- Effectiveness of the implemented Quality Management System for Corporate R&D Area including Affiliates
- Compliance in GVP, GCP, GLP, GMP and Computer System Validation
- Continuous improvement of the organisation and its processes.
She is qualified as Responsible for Quality Management System (ISO 9001 standards) and as “Lead Auditor”.
She is also qualified as “GVP Lead Auditor” in compliance with EU GVP Module IV (IV.B.3.1.2).
She performed multiple GxP Audits, Compliance Assessments and successfully completed GxP Inspections carried out by EMA, FDA, AIFA, Italian Ministry of Health and other European National Competent Authorities. She is an active member of:
- GIQAR (the Italian Group of Quality Assurance in Research)
- SIMEF (Società Italiana di Medicina Farmaceutica)
- AFI (Associazione Farmaceutici Italiani)
- ISOP (International Society of Pharmacovigilance).
She attended multiple national and international events as speaker, trainer, and chairman.
“La sperimentazione Clinica in Italia” and “Pharmacovigilance Audit Manual” written by Daniela, were published as part of SIMEF (previously SSFA) activity.
The course is designed for any professional involved in any Pharmacovigilance activity, including Pharmacovigilance Managers, Drug Safety Officers, Pharmacovigilance Assistants, Qualified Person Responsible for Pharmacovigilance (QPPV), Quality Managers (QA) and Auditors.
Participants must have at least a 1-year experience in Pharmacovigilance or in Quality Assurance / Quality Compliance to fully appreciate this advanced workshop.
The course will be an interactive workshop between the lecturer and participants, giving the possibility to deepen the various themes through the debate and the sharing of practical examples and real situations.
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 1.315,00* (until 22 April 2020)
Ordinary: € 1.545,00*
Freelance - Academy - Public Administration**: € 715,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Wednesday, April 22, 2020
At the end of the training, you will be able to
Analyze and evaluate GVP’s regulatory requirements
Have a comprehensive understanding of critical Pharmacovigilance processes
Implement and manage GVP Compliance, ensuring Inspection Readiness to the company