Barcelona. The New EU Regulation 2017/745 on Medical Devices. Wednesday 14 and Thursday 15 November and 15 November Barcelona.

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1 Understanding the Regulation and its impact on Industry Course Language: English 210 Early Bird discount for enrolment by 17 th October 2018 Barcelona Spain Wednesday 14 and Thursday 15 November :00 18:00 Taking part in our training courses, Michela Rimondini e Monia Dardi Il Vaso di Fiori you support "The Vase of Flowers" project For additional information: +39 (0) training@lsacademy.com

2 Introduction The recently published EU Regulation on Medical Devices 2017/745 (MDR) changes significantly the landscape for the medical device industry. Beyond the familiar framework of general requirements for safety and performance, harmonized standards, risk classification, the Regulation introduces novel requirements in key areas such as stronger Notified Body Oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements and Post Market Surveillance. The Regulation also introduces the concept of a responsible person for regulatory compliance for manufacturers and additional duties for importers and distributors. The Regulation also brings new evaluation procedures for high-risk devices and scrutiny of conformity assessments. For the industry, it is just the right moment to get a detailed understanding of the new requirements and understand how to prepare for the end of the transition period in May The Seminar allows participants to get a clear picture of the new requirements, understand the transition timelines and insure compliance to the new landscape. The Seminar includes detailed presentation materials, interactive sessions on technical dossiers, case studies and tool kits helpful for MDR implementation. To whom it may concern The seminar is targeted to industry in the field of medical devices particularly high-risk products. The seminar will benefit to: QA Managers R&D Managers Regulatory Affairs Managers Clinical Trail Managers CEO / CTO s of companies Type of Training The Seminar will consist in modular lectures, cases studies and interactive sessions (Q&A). Participant experience Knowledge of the medical device directive MDD 93/42 is necessary.

3 Programme Course language: English Day 1 10:00am to 18:00pm Module 1 Understanding the MDR 2017/745 Overview MDR vs. MDD Key changes Opportunity or threat? Module 2 Transition Period Transition for industry Transition for notified bodies Current state of designation procedure for notified bodies Notified body selection considerations Module 3 Walkthrough the MDR Preamble Chapters Annexes Implementation regulations Module 4 Classification and conformity assessment Classification rules and conformity assessment procedures Clinical evaluation consultation of certain class III and IIb devices and scrutiny Clinical evaluation and clinical investigation rules Recap day one / Q&A

4 Day 2 08:30am to 16:00pm Module 1 Person responsible for regulatory compliance Qualification requirements Duties Organizational impact Module 2 Technical Documentation case study New modules of Technical Documentation New General Safety and Performance Requirements Tool box project management Tool box technical documentation impact Module 3 Post market requirements for manufacturers Overview of post market requirements Periodic Safety Update Reports - PSURS Summary of Safety and clinical Performance - SSCP Recap day two / Q&A Agenda Day 1 Day 2 9:30-10:00 Participants registration 8:30 Course commences 10:00 Course commences 10:30-10:45 11:30-11:45 12:30 Lunch 13:00 Lunch 14:45-15:00 15:45-16:00 18:00 End of day 1 15:30 16:00 Q&A and Questionnaire completion Conclusion

5 Lecturer's Bio Mr. Arkan Zwick is 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 ten years, regulatory professional experience Arkan s role includes regulatory advocacy for drug, medical device 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 graduate master degree in Law from the University of Vienna and a PhD in European Law. He has been assigned as lecturer at the University of Applied Sciences in Vienna and speaker on life cycle conferences. He is fluent speaker in English, German and French. At the end of the training, you will be able to: Understand content of the new Medical Devices Regulation. Understand the impact on your organization during and after transition. Use tool boxes for the implementation of MDR in your company. In Company Training - Tailor-Made Training LS Academy can offer in company tailor-made training courses to meet specific learning needs. Contact us to design your training course: Tel: +39 (0) Fax: +39 (0) training@lsacademy.com

6 TO REGISTER FOR THE COURSE YOU CAN FILL IN AND SEND THE REGISTRATION FORM OR DIRECTLY REGISTER ONLINE: REGISTRATION FEES: Methods of payment Early bird: 1570,00* until 17/10/2018 Ordinary: 1780,00* Freelance Academy Public Administration: 890,00* *For Italian companies: + 22% VAT The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. The full amount must be paid on registration to EasyB s.r.l by bank transfer or by credit card. If paying by bank transfer please attach proof of payment to the registration form. Bank transfer payable to: EasyB S.r.l. Via Roma, Alzano Lombardo (BG) P. IVA Banco BPM - Filiale di Carobbio Degli Angeli IBAN: IT81 F SWIFT CODE: BAPPIT21AY5 For additional information: Secretarial office Phone Fax Mail LS Academy +39 (0) training@lsacademy.com Please fill in and send: (+39) Surname Company Address City Tel. Special Dietary Requests Invoicing details Company name Address Mail address (If different) City VAT number Terms & conditions training@lsacademy.com Name Job title Post code Fax. Post code or register online. Terms of payment The registration fee must be paid at the time of registration. Confirmation of course admission will be given on receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants. Cancellation Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the course date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities. LS Academy reserves the right not to accept registrations not compatible with the event s target audience. The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course. In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT ) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link. LSACADEMY.com Date Signature