Date

21 - 22 September 2020

Location

Barcelona

Language

English

MedDev Day

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MedDev Day

MedDev Day


Since the Medical Devices Regulation (MDR) 2017/745 entered in force and reached its date of application in May 2020, the MedTech industry has been extremely busy adapting processes, organisational flows and documentation to comply with the new requirements. This regulation obliged the industry to meet several goals. Among others:

  • Having an appropriate quality system (QMS) in place
  • Naming a person responsible for regulatory compliance (PRRC)
  • Seeking the acknowledgment of sufficiency of clinical data by notified bodies and competent authorities
  • Implementing clinical strategies for sufficient clinical data in the planning and reporting phases of a product’s lifetime
  • Complying with new post market surveillance requirements in the form of Periodic safety update reports (PSURS) and summary of safety and clinical performance (SSCP)

The new Medical Devices Regulation requirements vary significantly depending on the device’s risk class. Being well informed is a must to ensure compliance of legacy products and to plan an appropriate strategy for new registrations in the pipeline. In this new regulatory environment, a clear understanding of the rules, an update on guidance documents and notified bodies activities, as well as the input from industry experience are key to support both, the infrastructure needed to obtain appropriate clinical evidence and the new clinical workload.  

This second edition of the MedDev Day will shed light on the MDR rules after the date of its application with a clinical focus. We will share experiences and real-life examples from notified bodies, competent authorities, and industry on how to cope with regulations. The event will address topics such as: 

- The EU perspective: Latest developments in MDR implementation regulations, Common Specifications and Guidance Documents with an impact on clinical data.
- The notified body perspective: Notified body experiences from stage one, audits on Medical Devices Quality Management System readiness, and MDR product certification. Expectations!
- Discussions on Common Specifications (CS) for MDR Annex XVI devices without medical purpose. Impact of CS on planning sufficient clinical data.
- The Role of the person responsible for regulatory compliance (PRRC) in the clinical strategy and investigational devices. Liability and risk mitigation.
- How to assess and close gaps in clinical evidence. Challenges in the clinical evaluation and investigation route. The role of post market surveillance clinical data.
- Practical Medical Devices clinical evaluation plans and clinical evaluation documentation per device risk class:

  • Clinical evaluation plans and clinical development plans for class I, II and III products in line with the revised ISO 14155.
  • Post market clinical follow up (PMCF) plans and reports for class I, II and III products.
  • Post market surveillance (PMS) documentation, periodic safety update reports (PSURS) and summary of safety and performance characteristics (SSCP) how and what to compile for each device class.
  • Combination products (Device-Drug / Drug-Device): Clinical aspects, Art 117 MDR consultation and guidance on quality requirements for drug-device combination products. 
The second edition of the MedDev Day combines a pre-conference workshop on clinical evaluation reports (CERs) for combination products and the related summary of safety and clinical performance (SSCP). A comprehensive overview and update on changes affecting the device and an opportunity to exchange experience. This workshop, with a limited number of participants, provides the appropriate platform to enable high-level and focused discussions bringing together quality, regulatory and clinical expertise from Medical Devices and Pharma industry, CROs, Regulatory Authorities and Academia.

Scientific Board

Francesco Dell’Antonio - Vice President, Regulatory Affairs and Quality Assurance at Quanta System
Laura Michellini - Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Who should attend?

The event is designed for professionals in the field of Medical Devices, devoted to departments such as: Clinical Operations, Product Managers, Regulatory Affairs, Quality Assurance/Control, Risk Management, Medical Device Engineering, Device vigilance, R&D, Medical Affairs, Medical Writing from Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organizations.


Sponsor


For sponsorship opportunities, please contact events@lsacademy.com

Certificate of attendance

Certificate of attendance

21 September 2020 

PRE-CONFERENCE WORKSHOP


Half-day training on clinical evaluation reports (CERs) for combination products


Stay tuned for further details!

More details coming soon

Scientific Board

Francesco  Dell’Antonio
Francesco Dell’Antonio Vice President, Regulatory Affairs and Quality Assurance at Quanta System Spa
Laura Michellini
Laura Michellini Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Arkan Zwick
Arkan Zwick Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

More details coming soon

Scientific Board

Francesco  Dell’Antonio
Francesco Dell’Antonio Vice President, Regulatory Affairs and Quality Assurance at Quanta System Spa
Laura Michellini
Laura Michellini Scientific Director at Contract Research Organizations Latis Srl and Elle Research Srl
Arkan Zwick
Arkan Zwick Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Sponsors

Media Partners

Conference Venue

Novotel Barcelona City
Avenida Diagonal 210 (entrada por Ciutat de Granada), 08018 Barcelona, Spain

Novotel Barcelona City hotel is located on one of the main streets (Avenida de la Diagonal) in the heart of Barcelona. With its cosmopolitan vibe and streets imbued with art thanks to the famous architect, Gaudí, Barcelona is one of Spain's best-known cities.

  290 metres from Glòries metro station (Lines 1)

  18 km from Barcelona-El Prat airport

  In addition to the hotel venue, here is some recommended hotels for accommodation in the nearby:

              - The Gates Hotel Diagonal Barcelona (at 70 mt)     
              - Hotel SB Glow (at 250 mt)
              - Hotel Golden Tulip Barcelona (at 500 mt)

  Nearby restaurants: El Racó de la Vila (at 900 mt.)

Useful information

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 networking lunch will provide a pleasant moment of refreshment and an opportunity for you to network with your industry peers. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.



Conference Room
All our conference facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the conference. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click.



Informative literature
All the necessary information for the Conference is provided. The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.

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. 

Useful numbers

Ilaria Butta
Ilaria Butta Events & Training Executive
Enrico Pedroni
Enrico Pedroni Managing Director
Valeria Quintily
Valeria Quintily Project & Scientific Manager

Past Events

Conference Price

1345.00 €

Super Early Bird

Friday, June 19, 2020

1090.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

For information:

Contacts:

Ilaria Butta
Ilaria Butta Events & Training Executive
Enrico Pedroni
Enrico Pedroni Managing Director
Valeria Quintily
Valeria Quintily Project & Scientific Manager
Organised by

Technical and scientific training in the
pharmaceutical field
Via Roma 20 – 24022 – Alzano Lombardo (BG)
Tel: +39 035 515684

Participants' Feedbacks

Variety of topics, key messages around clinical impact were detailed well, speakers engaging and knowledgeable

Good organization/logistics, quality of speakers

Positive the combination workshop + conference

Good overview a lot of MDR aspects, possibility to ask questions and exchange with other participants

The speakers were quick open to speak also after the presentation, good mix of speakers

Conference was very well focused on the really problems of the companies in this phase

Well-thought agenda, networking, catering and hotel

Agenda covered a lot of different topics within a day. speakers were very open to answering questions even outside of the session

Organisation great, was very helpful via email prior to the conference (durign registration) 

good group size, good organization

Broad overview of different fields of application, insights into unknown territory conderning MDR

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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

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@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, to change its performance from residential to webinar/online. 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, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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.