Medical Devices Conference 2022

Introduzione

The MDR has been applicable since May 2021.
Over the last years, industry and regulators have made significant efforts to adapt to the Regulation.
Recent improvements are, among others, the number of notified bodies designated under MDR, the preparation and voluntary use of EUDAMED modules, the significant increase of MDCG Guidance documents and the activities and opinions of expert panels for certain high-risk devices.
This is in line with the overall goal of the Regulation to increase the attractiveness of the EU market as well as the quality, safety and performance of devices for patients and consumers.

Despite positive developments, the overall capacity of the regulatory system still needs to be improved.
While manufacturers have concerns about meeting the requirements of the MDR by the end of the transition, the system's capacity needs to be increased to process the number of certificates that need to move from MDD/AIMDD to MDR.

In early 2023, a legislative proposal by the European Commission was published that aims to extend the transition period and validity of certificates under certain conditions to 2027 for high-risk and to 2028 for medium and low-risk devices. This legal proposal is accompanied by supporting non-legislative measures that aim to support notified body capacities, back the industry and ensure the uninterrupted availability of medical devices.

In this dynamic context, the 5th edition of MedDev Day will give you a chance to rest and understand where the regulation stands. The conference will give insight into recent developments impacting MedTech industry and bring representatives from competent authorities, notified bodies and industry to share strategies, best practice solutions and recommendations.

A pre-conference workshop will precede the MedDev Day on Writing the Summary of Safety and Clinical Performance (SSCP): from good to excellent!

The conference will highlight the regulators’ perspective on the MDR state of play, non-legislative support measures, and conditions to be met by manufacturers to benefit from transition provisions and extended certificates. Also, practical insights on how to apply for temporary bridging measures under Article 97 will be conferred.

The MedDev Day will further reveal developments in clinical evaluation consultation opinions and state of play for the voluntary advice to manufacturers on clinical development strategy and clinical investigations. Participants will finally have the opportunity to understand the next steps and an outlook on the future of the regulatory system beyond 2024.

The Scientific Committee:

Scientific Board
Bassil Akra - Chief Executive Officer at AKRA TEAM GmbH
Sabina Hoekstra-van den Bosch - Regulatory Strategy Principal at TÜV SÜD
Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical

MedDev Day Scientific Coordinator
Laura C Collada Ali - Senior Medical Writer & Scientific Manager at LS Academy

Who should attend?
The conference 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., competent authorities, EU Commission and Surveillance authorities.

Programma

From 9:00 to 16:30
The Programme is currently under definition

	Notified Body view. Impact of MDR transition extension and of MDCG 2022-14 on MDR transition Sabina Hoekstra-van den Bosch - Regulatory Strategy Principal at TÜV SÜD
	Outlook on the future of the Regulatory system - an industry whish list Christina Ziegenberg - Deputy Managing Director, Head of Regulatory Affairs at BVMed, Berlin
	Experience from Industry with MDR transition extension and of MDCG 2022-14 Bassil Akra - Chief Executive Officer at AKRA TEAM GmbH
	Company experiences with device-drug combination Arkan Zwick - Corporate Regulatory Affairs Director at CROMA Pharmaceutical

Relatori

Info Scientific Board

Bassil Akra

Chief Executive Officer at AKRA TEAM GmbH

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent the last year consulting and supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.

Info Scientific Board

Sabina Hoekstra-van den Bosch

Regulatory Strategy Principal at TÜV SÜD

Sabina is Regulatory Strategy Principal at Notified Body TÜV SÜD and acts as representative of TÜV SÜD and Notified Bodies at European level. She is Chair of NBCG-Med, the EU Commission’s working group of Notified Bodies, and Vice-President of Team-NB, the EU Notified Bodies’ association. Sabina has 20 years of experience as pharmaceutical and medical device regulator, serving subsequently in the Medicines Evaluation Board, the Ministry of Health and the governmental organization for clinical investigations in the Netherlands. She has worked in medtech industry as Lead for European Regulation in Philips, where she acted as leader and expert in European Medical Device and Pharmaceutical Regulations on corporate level and was involved in EU MDR/IVDR implementation. Sabina has a long track record as volunteer in global professional organizations (DIA and RAPS). She is a regular speaker and faculty member in educational conferences on regulatory topics. She was co-founder and Chair of the RAPS Netherlands Chapter. She is Fellow of RAPS since 2015 and serves in RAPS Global Board of Directors since 2020. Sabina holds a PharmD from Leiden University.

Info Scientific Board

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical

Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific. Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.

Info Speaker

Christina Ziegenberg

Deputy Managing Director, Head of Regulatory Affairs at BVMed, Berlin

As a natural scientist in the field of chemistry and pharmacy and a doctorate in scientific medicine, Christina began her career as a chemical development engineer in the building and construction industry within the field of explosives. Subsequently she took over market surveillance and enforcement tasks in the areas of medical devices, IVDs and radiation protection as head of Medical Devices in the Office of Public Health of Liechtenstein which is the Competent Authority for medical devices and IVDs in Liechtenstein. In April 2019 she continued her career at BVMed, the German Medical Technology Association, where she took over responsibility for regulatory affairs with a focus on medical devices but also environmental and sustainability.

Workshop

25 September 2023

PRE-CONFERENCE WORKSHOP

From 13:30 to 17:30 | NH Vienna Airport, Vienna

From Good to Excellent: The Summary of Safety and Clinical Performance (SSCP)
An advanced training to improve your SSCP and write it in the most efficient way

Introduction
The Summary of Safety and Clinical Performance (SSCP) is a document that is with a unique structure and format: it is intended to include detailed information on a medical device for both healthcare providers and patients and will be available for the public. Many manufacturers already know how to write an SSCP.

We also have read MDCG 2019-9, but how can we go from good to excellence? And how can we improve a document which will be public soon?
To be able to work on your SSCP you need strong technical skills. You also have to be able to translate the technical documentation into lay language: Are we complying with a regulatory requirement or are we really communicating with the public?
Consistency with the Technical Documentation, different expectations from the manufacturer and the Notified Body and strict timelines are additional hurdles.

This workshop will navigate you through the needed skills to achieve excellence and positively impact the final document.

Programme

Introduction to Article 32 of EU MDR 2017/745 (Summary of Safety and Clinical Performance)
Structure and Content: The MDCG (Medical Devices Coordination Group) Guidance 2019/9
How to optimize input documents for more efficient SSCP writing
Best practice tips to summarize safety and performance data
How to improve the patients’ section of the SSCP

Who should attend?
The workshop is addressed to Clinical Affairs, Quality Assurance, Product Managers and Medical Writers.

Participant experience
This workshop is intended for personnel with little experience in regulatory writing, including the Summary of Safety and Clinical Performance, under the Medical Devices Regulation 2017/745 (EU MDR) and with little experience in the preparation of lay summaries.

Teaching methods
The workshop will be a mixture of presentations, team discussion, brainstorming and practical examples.

Lecturer

Dr. Katharina Friedrich, MD – Freelance Medical Writing Consultant
Katharina Friedrich is a medical writer with 5 years of experience in MDR regulatory writing. She is based in Heidelberg, Germany and works as a Freelance Medical Writing Consultant for various medical device companies, including startups and global players. She prepares Clinical Evaluation Plans and Reports, PMCF Plans and Reports and SSCPs in compliance with MDR 2017/745 for class I to class III devices. She also supports development projects and the conduction of PMCF activities. As medical doctor she has experience in the field of orthopedic, spine and trauma surgery and intensive care medicine.

At the end of the training, you will be able to:

Understand the regulatory requirements for the SSCP
Optimize the relevant input documents for the SSCP and learn how to extract the most relevant information
Prepare lay summaries, including product description and summary of study results
Prepare a summary of safety and performance information for healthcare professionals
Understand common pitfalls with the preparation of the SSCP and know how to avoid them

Contatti

Laura C Collada Ali
MedDev Day Scientific Coordinator
medicalwriting@lsacademy.com

Ilaria Butta
Events and Training Manager
ilaria.butta@lsacademy.com

Quote di iscrizione

Pre-Conference Workshop + Conference:

€ 1.045,00* SUPER Early Bird fee until 01 July 2023
€ 1.105,00* Early Bird fee until 29 August 2023
€ 1.310,00* Ordinary fee
€ 660,00* Freelance, Academy, Public Administration

Fee includes: seat at the training. seat at the conference, training material, copy of presentations of Speakers who allow the distribution, coffee breaks, networking lunch, organisational office assistance, certificate of attendance.

Pre-Conference Workshop:

€ 560,00* Early Bird fee until 29 August 2023
€ 670,00* Ordinary fee
€ 310,00* Freelance, Academy, Public Administration

Fee includes: seat at the training, training material, coffee break, organisational office assistance, certificate of attendance.

Conference:

€ 670,00* Early Bird fee until 29 August 2023
€ 790,00* Ordinary fee
€ 430,00* Freelance, Academy, Public Administration

Fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, networking lunch, coffee breaks, organisational office assistance, certificate of attendance.

* for Italian companies: +22% VAT

Informazioni utili

The conference will take place at:

NH Vienna Airport
Einfahrtsstrasse 1- 3, 1300 Vienna

The NH Vienna Airport Conference Center hotel enjoys a convenient location just across from the arrivals hall at Vienna Airport. That means we have unbeatable transport links – if you want to head into the city, it’s just a 16-minute train ride to central Vienna.

From Vienna International Airport (VIE): it is a 6 min walk to get to the hotel
Closest metro station: Flughafen Wien (City Airport Train)
To get to the city center of Vienna, you can use the City Airport Train, which departs every 30 minutes. The trip will take 16 minutes. Click here for the timetable.

COVID-19
LS Academy is aware of the evolving impact of COVID-19 and is committed to offering safe and secure face-to-face courses and conferences. From physical distancing, protect, detect, cleaning and hygiene. LS Academy ensures that all our events are conducted in accordance with official government guidelines and regulations, understanding that these measures may vary and change as the situation evolves.