Introduzione

The EU Regulation on Medical Devices 2017/745 (MDR) changes significantly the landscape for the medical device industry. The new Regulation introduce novel requirements in key areas such as stronger Notified Body (NB) and Competent Authority (CA) oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements as well as scrutiny for advertisement and labelling. Also national regulations provide for specific requirements as for the advertisement of devices, prior approval requirements by authorities and transparency regulations for relations with health care professionals (HCPs).

The course will give insight on the laws and regulations governing the marketing and promotion of medical devices in the European Union (EU). It helps industry to keep their sales reps, marketing professionals, and other employees that have contact with healthcare providers in compliance with these laws and provides guidance how to establish effective marketing and claims compliance processes. It will also help participants to learn about the consequences to violating the advertisement laws.If you have encountered one of the following questions, this course will be giving you the right answers:

  • How is the EU market structured and what levels are responsible for supervision of industry marketing and promotion?
  • What laws and regulatory documents are applicable to my marketing and promotion activities?
  • In what way will my marketing and promotion materials be scrutinized by the competent authorities and notified bodies?
  • What is a sound basis for my marketing and promotion claims?
  • How do I insure compliant release processes (SOPs) at corporate and regional level for multi country promotion activities?
  • Can I promote my professional use device 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, authorized representative, distributor?
  • As a sales or marketing professional, what are my responsibilities? What qualification 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 key changes in regulations impacting marketing promotion
  • Claims regulations in the EU
  • Risks of false claims and unlawful advertising
  • National laws and guidance documents
  • Is comparator advertisement allowed?
  • Case studies

Part 2: Claims and Advertising

  • Basis for advertising and promotion. The role of the technical dossier, labels and national laws
  • Who is involved in the company and market side? Role of notified body, competent authorities and competitors
  • What type of promotional claims go too far
  • Does and don’ts for claims and event management
  • How to avoid false claims and handle off label use
  • Communication in company and control processes – SOP examples

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
Info

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria
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.

This online training consists of 1 module:

November 3rd,  2021 – from 9:00 am to 1:00 pm CET

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: € 465,00* (until 6 October 2021)

Ordinary: € 595,00*

Freelance – Academy – Public Administration**: € 370,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – 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.

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand laws and regulations governing the marketing and promotion of medical devices in the European Union (EU)
Risultato atteso
Prepare the MedTech industry to keep sales reps, marketing professionals and other employees that have contact with healthcare providers in compliance with these laws
Risultato atteso
Understand how to establish effective marketing and claims compliance processes
Risultato atteso
Understand risks and the consequences to violating the advertisement laws

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

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