Data

22 September 2020

Location

Virtual

Lingua

English

MedDev Day Virtual

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MedDev Day Virtual

Covid-19 is creating the biggest international emergency nowadays. 
But MedDev Day doesn’t stop, the conference will move to a new format: MEDDEV DAY VIRTUAL. 

Virtual conference with presentations, slots for Q&A and discussion among delegates.
Join the virtual conference and keep you updated about the most interesting topics around the medical devices field!

MedDev Day

Since the Medical Devices Regulation 2017/745 (MDR) entered into force, the MedTech industry has been busy adapting processes, organisational flows and documentation to comply with the new requirements. After the MDR compliance date being postponed by 12 months until May 2021 to respond to COVID-19 limitations, the MedTech industry still needs to focus on managing the final steps of the transition period to align strategies within this new challenging environment. The regulation obliges the industry to meet several goals. Among others:

  • Having an MDR compliant quality system (QMS) in place within the context of remote audit implementation
  • Defining the organisation of a person responsible for regulatory compliance (PRRC)
  • Seeking the acknowledgment of sufficiency of clinical data by notified bodies and competent authorities while managing clinical trials
  • Implementing clinical strategies to meet the requirements of the MDR as regards to clinical development, equivalency approach, sufficiency of clinical data for legacy devices and post market clinical follow up plans and reports
  • 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 CE markings in the pipeline. In this 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 a few months before 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 Clinical Guidance Documents
  • The notified body perspective: Notified body experiences on audits on Medical Devices Quality Management System readiness, and MDR product certification. Lessons learned from past audits including remote audit situation
  • The Industry perspective: how to use the remaining months for MDR readiness and MDD projects
  • 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 investigation 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.

The second edition of the MedDev Day will be a one day fully virtual meeting and will bring 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

22 Settembre 2020

Abstract available soon

Dario Pirovano Dario Pirovano – Senior Regulatory Adviser at MedTech Europe

The growing use of devices that do not have a specific purpose in the medical field but that are used both in the professional and private sectors, has pushed the European legislator to insert them in the EU Reg. 745/2017 (MDR) to protect not only the public health but also manufacturers and end users. These devices are specifically identified in Annex XVI of the MDR Regulation and among these are predominant those used in the aesthetic field, such as coloured contact lenses, fillers or other skin injectables (except those used for tattoos), equipment used for liposuction, lipolysis or lipoplasty.
The manufacturers of devices for aesthetic use, having to fulfil these new obligations, shall start planning an adequate Quality Management System and prepare the Technical Documentation required by the MDR Regulation and adhere to the requirements that will be described within the Common Specifications (CSs).

Melania Battistella Melania Battistella – Global Manager Aesthetic Products at TUV SUD

Abstract available soon

Adem  Koyuncu Adem Koyuncu – Lawyer and Medical Doctor, Partner of law firm Covington & Burling LLP

Regulation 2017/745 (MDR) puts a much stronger emphasis on Post Market Surveillance compared to the current MDD. We will discuss the PMS plan as central document in the device life cycle, its content and how the data gathered through PMS activities will be reported. A link between the risk management file and trend reporting as outlined in Article 88 of the MDR will be established. The Periodic Safety Update Report (PSUR) for device classes IIa, IIb and III will be discussed in more detail, incl. the use of IMDRF codes for more uniform reporting. 

Ralf Labugger Ralf Labugger – Regulatory Affairs Compliance Manager at Croma-Pharma

Regulation 2017/745 (MDR) and 2017/746 (IVDR) were released with a clear desire to place patients and users of medical device at the center of device development and post-market surveillance. With a strong focus on safety and proactive risk management, the new regulations take device vigilance requirements from guidance into law and will certainly lead to higher oversight by Competent Authorities and Notified Bodies. Companies need to prepare for higher scrutiny without the support of guidance and facing much uncertainty on elements newly introduced by the MDR / IVDR text. While the recent delay in the MDR date of application will allow manufacturers to benefit from additional time to prepare, there is substantial work required and early and proactive readiness will help secure the product portfolio. This presentation shares the lessons learned on preparatory work and certification audit experience for the first successful medical device certificate under Regulation 2017/745 in 2019.

Laura Gámez Laura Gámez – Senior Pharmacovigilance Process Manager at Novartis

More details available soon

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

Relatori

Melania Battistella
Melania Battistella Global Manager Aesthetic Products at TUV SUD
Laura Gámez
Laura Gámez Senior Pharmacovigilance Process Manager at Novartis
Adem  Koyuncu
Adem Koyuncu Lawyer and Medical Doctor, Partner of law firm Covington & Burling LLP
Ralf Labugger
Ralf Labugger Regulatory Affairs Compliance Manager at Croma-Pharma
Dario Pirovano
Dario Pirovano Senior Regulatory Adviser at MedTech Europe

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

MedDev Day Virtual

Virtual conference with presentations, slots for Q&A and discussion among delegates.

Informazioni utili

LS Academy will provide the link to join the conference some days before the conference date.

Fee includes: access to the virtual conference, organizational support, certificate of attendance, slide presentations in pdf format provided post-event.

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

560.00 €

Super Early Bird

venerdì 31 luglio 2020

410.00 €

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

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2000
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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


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