Discover the course
Quality Risk Management - Workshop
A definition of the risk management process in clinical research
Risk Management is a regulatory requirement of the pharmaceutical world. Risk Management should be the approach of choice for the entire life cycle of a medicinal product. Risk management requires the careful involvement of different professional roles to build an interdisciplinary team that guarantees the success of the approach itself. In the team, some of the essential roles should be: Quality Assurance and Process Owner(s), with different, still equally important, roles and responsibilities.
Quality Assurance professionals and GCP Managers are key actors involved in the different phases of the planning and conduction of Clinical Studies; where Risk Management finds its full application.
The course aims to provide the basic concepts and elements of risk management in the GxP field and in particular in Clinical Research.
These basic concepts will be followed by a detailed description of the different phases of the risk management cycle, including the Risk Mitigation process, identifying the roles involved and the related responsibilities.
The lecturing section will be followed by examples of practical applications with references to real-life cases drawn from the trainers’ experiences.
Tools and related documents (e.g. Risk Register) will be described and discussed.
After a Master’s degree in Chemistry and Pharmaceutical Technologies, she began her professional career in 1999 as a hospital pharmacist (UF Farmaceutica Territoriale Zona Val di Cornia, Piombino, Livorno). In 2003 she joins MolMed SpA as Clinical Research Associate and then takes on the role of Drug Safety & Clinical Quality Assurance Officer in 2006. In 2016 she joined Accelovance Europe srl (formerly THERAMetrics SpA) as Head of Global Quality Services & Business Excellence. In 2017 she joins SeQure Life Sciences srl (formerly PM Clinical Ltd) as Senior GxP QA Consultant. She is an expert in the field of quality assurance systems and GCP regulatory compliance; she has conducted many GCP audits. Over the years, she has had several experiences of regulatory inspections conducted and / or coordinated by regulatory authorities such as: EMA, FDA, AIFA. She is an active member of the Italian Quality Assurance Research Group (GIQAR).
After a Master’s degree in Chemistry and Pharmaceutical Technologies, Antonella starts her professional career as a chemical researcher at Glaxo SpA in 1986. In 1994, she becomes the Head of the Medical Chemistry Unit at GlaxoWellcome, and in 2001 she takes the role of Head of Project Strategy and Support in the field of Chemical Development and GMP Manufacturing. In 2002, she works within Preclinical Development in GlaxoSmithKline and takes on the role of Head of Business Operations and, subsequently Head of Projects Operations. Up to 2010 she coveres different roles and in this year she takes on the role of Quality & Compliance Senior Director, for the sites of Verona and Oxford. In 2017, she joins seQure Life Sciences srl (formerly PM Clinical Ltd) as Director of Quality Assurance & Compliance Consultancy. In 2018, she takes on the responsibility for the Service Delivery Department and the role of Managing Director in January 2020. With more than 20 years managerial experience in the pharma field, she has proven experience in applying scientific knowledge and in the development and optimization skills of Drug Discovery processes with in-depth knowledge in the GxP field. She has been granted the LSS Black Belt certification for her Operational Excellence and Planning techniques. She is an active member of Research Quality Association (RQA) and of the Italian Pharmaceutical Association (AFI). Author and co-author of 7 patents and several publications. She has participated as a speaker in many conferences both nationally and internationally.
The course is designed for all professionals involved in planning, conducting, monitoring and auditing clinical trials: project manager, study manager, monitor, QA, auditor. In particular, it addresses professionals involved in the study-specific risk management.
It is advisable to have experience on:
- Quality Assurance: 6 months to 1 year
- Management of clinical trials under GCP: 6 months to 1 year
Lectures, role playing, exercises
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: € 905,00* (until 22 April 2020)
Ordinary: € 1.025,00*
Freelance - Academy - Public Administration: € 540,00*
* 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
Proactively contribute to risk management in a clinical trial
Ensure risk control throughout all the study
Share the Risk Management methodological approach in one's own professional environment
Be aware of appropriate tools to conduct risk analysis
Have a more in-depth knowledge of the roles and responsibilities of the various figures involved