Discover the course

Quality Risk Management - Workshop

A definition of the risk management process in clinical research

Date

13 May 2020

Location

Milan

Language

Italian

Quality Risk Management – Workshop

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.


Course Language
The course will be in Italian.
Antonella Troysi
Antonella Troysi Senior GXP QA Consultant - seQure Life Sciences srl

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).

Antonella Ursini
Antonella Ursini Managing Director - seQure Life Sciences srl

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.


Participant experience

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


Hotel Melià
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.


Upon Arrival
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.

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.



Training Room

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.



Teaching materials

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.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.


Brochure
Certificate of attendance

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.

Register now

Course Price

1025.00 €

Early Bird

Wednesday, April 22, 2020

905.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1 day

Course Type

Limited number of partecipants

You will receive

Certificate of attendance

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

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Quality Risk Management – Workshop

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities.

Information collection and use
In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers, scientific board, speakers, conferences’ sponsor), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, 
following this link.