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General Data Protection Regulation (GDPR), Clinical Trials and Local Legislation

A training for understanding the impact of GDPR in clinical trials both at local and international level

Date

10 March 2020

Location

Milan

Language

Italian

General Data Protection Regulation (GDPR), Clinical Trials and Local Legislation

The EU's General Data Protection Regulation (GDPR) is the most important change in the management of privacy in the last 20 years.
The GDPR radically changes the way personal data are handled in any area, including health care and clinical trials. Pharmaceutical, biomedical and medical device companies have to restructure their personal data management systems to ensure compliance with the GDPR as well as the collection, storage, and use of personal data.
It is therefore essential for companies acquiring the necessary skills to perform what is needed to implement GDPR in scientific research. The application of the GDPR in clinical trials and scientific research must be done to guarantee the company's effectiveness and competitiveness. This is a complex but not impossible challenge. This training course on GDPR in clinical trials and scientific research aims to provide the basic tools to deal with this challenge.

Analysis and understanding of the applicable legislation on the management of personal data (GDPR):

  • The European and Italian legislation: Regulation (EU) 2016/679 and local regulations
  • Administrative, criminal, civil and insurance sanctions
  • Accountability
  • The lawfulness of treatment and legal bases in clinical trials, scientific research and in pharmacovigilance
  • Data integrity, security, privacy by design and by default
  • Minimisation and purpose of personal data processing (data re-use, biological samples, and administrative database)

Governance:

  • Treatment register
  • Roles in data processing (Sponsors, CROs, Centers, Laboratories, Monitors, etc.): Data Processor, Data Protection Authority (DPA) appointments and instructions
  • Extra EU data transfer: Limits and conditions
  • Data Protection Impact Assessment
  • Data Privacy Officer (DPO)
  • Qualifications and checks on suppliers
  • The future: certifications and codes of conduct

Clinical research and health database:

  • Specific regulations regarding data processing in clinical trials
  • Definition of genetic data
  • Prior consent
  • Simplified information
  • Research on populations of patients with mental incapacity
  • Retrospective research
  • Genetic retrospective research


Course Language

The course will be in Italian

Francesca Preite
Francesca Preite Freelancer, Senior Partner of Miari-Preite Law Firm

Freelancer, Senior Partner of Miari-Preite Law Firm in Reggio Emilia. Legal adviser in clinical research and health law, with specific know-how on personal data protection in epidemiological studies and in the management of clinical databases in health care. DPO in clinical-health companies. She has published several disclosures, including articles for the Italian Society of Medical Statistics and Clinical Epidemiology (SISMEC), on this topic.

Pharmaceutical, biomedical and medical device companies, CROs, Healthcare companies and hospitals, IRCCS, Nursing Homes, Laboratories, PMA Centers, Scientific Associations, Foundations, Non Profit Organizations, Freelancers and Consultants operating in the clinical-health field along with professionals who collect or manage data regulated by the GDPR in clinical trials and scientific research.

Interactive teaching.

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: € 790,00* (until 18 February 2020)

Ordinary: € 905,00*

Freelance - Academy - Public Administration**: € 485,00*


* 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

905.00 €

Early Bird

Tuesday, February 18, 2020

790.00 €

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

  • Maturing skills and competences to GDPR in scientific research

  • Implement and manage tools needed to comply with the requirements of GDPR in clinical trials

Participants' Feedbacks

very effective training with exercises

International and multidisciplinary profile of participants, which enriches the training

The limited number of participants allows a better interaction with the teachers, who can answer all the questions

broader view on publication writing

The theory parts were supported by very good concrete examples, which was great. Trainer was good and allowed for questions.

Choice of topics of great importance for pharmacovigilance activities

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General Data Protection Regulation (GDPR), Clinical Trials and Local Legislation

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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.