Introduzione
The EU Regulation on Medical Devices 2017/745 (MDR) significantly changed the landscape for the medical device industry.
The Regulation introduced novel requirements in critical areas such as stronger Notified Body (NB) and Competent Authority (CA) oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements, and scrutiny for advertisement and claims.
Also, national regulations provide specific requirements for the advertisement of devices, prior approval requirements by authorities and transparency regulations for relations with health care professionals (HCPs).
This course gives insight into the laws and regulations governing the marketing and promotion of medical devices in the European Union (EU).
It helps the industry keep their sales reps, marketing professionals, and other employees that have contact with healthcare providers in compliance with these laws and provides guidance on establishing effective marketing and claims compliance processes.
It will also help participants learn about the consequences of violating the advertisement laws.
If you have encountered one of the following questions, this course will give you the correct answers:
- How are EU markets structured, and what levels are responsible for industry marketing and promotion supervision?
- What laws and regulatory documents apply to my marketing and promotion activities?
- How will the competent authorities and notified bodies scrutinise my marketing and promotion materials?
- What is a sound basis for my marketing and promotion claims?
- How do I ensure compliant release processes (SOPs) at corporate and regional levels for multi-country promotion activities?
- Can I promote my professional use of devices in public and for lay persons? When do I need a Drs Check?
- Does a reimbursement status change my promotion capabilities?
- What is the risk of mislabelling or false advertisement?
- What is the responsibility of the manufacturer, authorised representative, and distributor?
- As a sales or marketing professional, what are my responsibilities? What qualifications do I need to promote products in Europe?
- What transparency rule do I need to follow?
Part 1: Introduction to MedTech regulations
- The EU market & law-making
- Overview and critical changes in regulations impacting marketing promotion
- Claims regulations in the EU. Common principles.
- Risks of false claims and unlawful advertising
- National laws and guidance documents
- Is comparator advertisement allowed?
- Case studies: Austrian and German law
Part 2: Claims and Advertising
- The role of the technical dossier for claims and advertising. Who is involved in the company, part of the notified body, or competent authorities.
- Does and don’ts for claims and event management
- Communication in company and control processes – SOP examples
- Type of claims and data needed.
- Case studies: UK, France, Spain, Italy.
Recap / Q&A
- Marketing and Sales staff
- Company managers
- QA/RA/Clinical Managers
- Company staff having responsibility for marketing compliance
Participant Experience
Basic knowledge in Medical Devices regulations would be of help
Online training comprising frontal lessons and Q&As.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharma, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than sixteen 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.
This online training consists of 1 module:
18 April 2024 from 9:30 am to 1:30 pm CEST
Some days before the online training you will receive all details about the connection.
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.
Early Bird: € 480,00* (until 28 March 2024)
Ordinary: € 615,00*
Freelance – Individual – Academy – Public Administration**: € 385,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Ilaria Butta
Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
