Data

21 - 22 September 2020

Location

Barcelona

Lingua

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

Attestato di partecipazione

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!

Maggiori informazioni disponibili a breve

Coordinatori Scientifici

Francesco  Dell’Antonio
Francesco Dell’Antonio Vice President, Regulatory Affairs and Quality Assurance at Quanta System Spa
Laura Michellini
Laura Michellini Direttore Scientifico presso le CRO Latis Srl ed Elle Research di Genova
Arkan Zwick
Arkan Zwick Direttore Corporate del dipartimento Regulatory Affairs di CROMA Pharmaceutical, Austria

Maggiori informazioni disponibili a breve

Coordinatori Scientifici

Francesco  Dell’Antonio
Francesco Dell’Antonio Vice President, Regulatory Affairs and Quality Assurance at Quanta System Spa
Laura Michellini
Laura Michellini Direttore Scientifico presso le CRO Latis Srl ed Elle Research di Genova
Arkan Zwick
Arkan Zwick Direttore Corporate del dipartimento Regulatory Affairs di CROMA Pharmaceutical, Austria

Sponsors

Media Partners

Sede della Conferenza

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.)

Informazioni utili

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. 

Numeri utili

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

Eventi passati

Prezzo della conferenza

1345.00 €

Super Early Bird

venerdì 19 giugno 2020

1090.00 €

Pagamenti accettati

  • Bonifico bancario
  • Carta di credito
  • PayPal

Per informazioni:

Contatti:

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

Formazione tecnico scientifica
in ambito farmaceutico
Via Roma 20 – 24022 – Alzano Lombardo (BG)
Tel: +39 035 515684

I Feedbacks dei partecipanti

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

I numeri di LS Academy

2000
Anno di fondazione
1
Corsi organizzati
1
Conferenze organizzate
1
Professionisti formati

Tariffa Gruppi

Contattaci per partecipazioni multiple e beneficiare del migliore sconto

Pagamento sicuro con

Servizio clienti

Lunedì - Venerdì: 9:00 | 13:00 e 14:00 | 18:00
+39.035.515684 - info@lsacademy.com

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Termini e Condizioni

Corsi
la quota comprende: Ingresso al corso, documentazione didattica, pranzi e coffee break, assistenza segreteria organizzativa, attestato di partecipazione.
Lo sconto early bird non si applica alla quota per Freelance – Accademia – Pubblica Amministrazione.
Il corso si svolgerà al raggiungimento di un minimo di 8 partecipanti. In caso contrario verrà data comunicazione agli iscritti almeno una settimana prima dalla data del corso.
Per maggiori informazioni riguardanti l’iscrizione all’evento, potete contattare la segreteria organizzativa:
training@LSAcademy.com oppure tel. +39.035.515684


Conferenze

la quota comprende: ingresso alla conferenza, copia delle presentazioni dei relatori che le hanno rese disponibili, materiale informativo della giornata, networking lunch, coffee break, assistenza segreteria organizzativa, attestato di partecipazione. Per maggiori informazioni riguardanti l’iscrizione all’evento, potete contattare la segreteria organizzativa: events@LSAcademy.com oppure tel. +39(0)35.4123594

 

Webinars
la quota comprende: Ingresso al corso, documentazione didattica, assistenza segreteria organizzativa, attestato di partecipazione. Lo sconto early bird non si applica alla quota per Freelance – Accademia – Pubblica Amministrazione.  Per maggiori informazioni riguardanti l’iscrizione all’evento, potete contattare la segreteria organizzativa:
training@LSAcademy.com oppure tel. +39.035.515684


Condizioni comuni per Corsi e Conferenze

Termini di pagamento

L’importo dovrà essere versato ad EasyB S.r.l. all’atto dell’iscrizione tramite pagamento online (con carta di credito) o tramite bonifico bancario. In caso di bonifico bancario, l’importo dovrà essere versato a EasyB s.r.l. all’atto dell’iscrizione a:

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

Solo la conferma dell’avvenuto pagamento consente la partecipazione all’evento. Seguirà fattura quietanzata. Iscrizioni ricevute in ritardo od oltre il numero massimo dei partecipanti o di figure professionali non in linea con il target dell’evento, potranno non essere accettate. Il pagamento della quota di iscrizione è dovuto contestualmente al ricevimento della scheda di registrazione. L’ammissione all’evento è confermata unicamente al ricevimento del pagamento. Potranno non essere accettate le iscrizioni ricevute in ritardo oppure oltre il numero massimo consentito dei partecipanti oppure di figure professionali non in linea con il target dell’evento.

Cancellazione
L’eventuale disdetta di partecipazione dovrà essere comunicata in forma scritta ad EasyB entro una settimana dall’evento. Il rimborso è pari al 70% della quota. Cambiamenti nei nominativi dei partecipanti: da comunicare ad EasyB entro 7 giorni dalla data dell’evento. EasyB si riserva il diritto di posticipare o cancellare un evento, di cambiare la location di un evento o di modificare il panel dei relatori di un evento, di modificarne l’esecuzione da residenziale a webinar. EasyB non è responsabile per qualsiasi perdita o danno risultante da sostituzione, cambiamento, rinvio o cancellazione di un evento per cause al di fuori del proprio controllo, incluso a titolo esemplificativo e non esaustivo, cause di forza maggiore, disastri naturali, sabotaggi, infortuni, vertenze sindacali, atti di terrorismo, guerre, epidemie, pandemie, e/o blocchi dell’autorità ( c.d. factum principis).

Informativa Privacy
Ai sensi dell’art. 13 Reg. UE 27 Aprile 2016 n. 679, La informiamo che EasyB S.r.l., corrente in Alzano Lombardo (BG), via Roma 20 C.F e P.Iva 03633040161, in qualità di titolare del trattamento, tratterà i dati personali da lei volontariamente forniti solo previo consenso e nel rispetto dei principi dettati dal Regolamento Europeo in materia di protezione dei dati personali per l’invio di newsletter, per finalità di marketing (invio materiale pubblicitario, ricerche di mercato e comunicazione commerciale) e comunicazione dei medesimi dati a terzi (docenti e relatori, board scientifico, aziende che sponsorizzano la conferenza) anche per finalità di marketing. Potrà leggere l’informativa completa, compresi i diritti a lei spettanti e le modalità per l’esercizio degli stessi, cliccando su questo link.