2 DAY WORKSHOP on Preparing For The New EU Medical Device Regulations (MDR)

Transcription

1 WORLD COMPLIANCE SEMINARS SPEAKER:- DAVID R DILLS Regulatory Affairs & Compliance Consultant 2 DAY WORKSHOP on Preparing For The New EU Medical Device Regulations (MDR) 21-22, FEB Burlingame CA Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Call us! Toll Free An event by: World Compliance Seminars

2 2 Days Workshop on EU Medical Device Regulations Speaker:- David R Dills SPEAKER DAVID R DILLS David R Dills Regulatory Affairs & Compliance Consultant David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness. He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/ctm and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing.

3 2 Days Workshop on EU Medical Device Regulations Speaker:- David R Dills COURSE SUMMARY The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation. The European Union released the Medical Devices Regulation (MDR 2017/745/EU) to eventually replace the Medical Devices Directive and Active Implantable Medical Devices Directive. The MDR introduces numerous changes, including a shift from the preapproval stage to more of a life-cycle approach. It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges and transition smoothly to the MDR. This seminar provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product lifecycle. You will gain a strong foundation of the key elements of the EU directives governing medical devices.

4 2 Days Workshop on EU Medical Device Regulations Speaker:- David R Dills Areas Covered Understand the Medical Device Regulations approach in Europe Understand the structure and purpose of the Medical Device Directives Understand the key changes upcoming in the new EU MDR Understand the essence of early start in the transition Understand how to prepare a transition plan Apply the Classification Criteria and Implementation rules Identify the conformity assessment routes Identify Technical Documentation requirements Importance and Role of Clinical Data Identify the importance and contents of Post Market Surveillance Explain and differentiate between the scope of the three EU device directives Cite the key requirements for postmarketing surveillance Explain the overall regulatory requirements for medical devices in the EU Comply with the implementation details and requirements of the EU MDR & IVDR Who will Benefit Senior Management Regulatory Affairs Managers and Quality Managers Design, Development, Manufacturing and Marketing Managers Auditors Compliance/Regulatory affairs professionals QA/QC professionals Manufacturing managers, supervisors Project Managers Compliance Officer Compliance Specialist Clinical Affairs Marketing & Sales Management Distributors/Authorized Representatives Legal Counsel Consultants

5 2 Days Workshop on EU Medical Device Regulations Speaker:- David R Dills CONFERENCE AGENDA Day 1 Schedule Introductions and Background The objectives of the MDR Scope & Definitions Placing CE marked product on the market EUDAMED and significance of the European Electronic Database Notified Bodies Classification and Conformity Assessment Clinical Evaluation & Investigations PMS and Vigilance Quality management system requirements in the MDR Device classification and conformity assessment routes changes in the MDR Technical documentation requirements Clinical evaluation process requirements UDI and traceability requirements Postmarket surveillance and reporting requirements Life-cycle review of products linked to risk management and clinical evidence Implications for Notified Bodies, and for organizations working with Notified Bodies Impact on product portfolios and classification The need for improved clinical evidence Strengthening of post market surveillance (PMS)

6 2 Days Workshop on EU Medical Device Regulations Speaker:- David R Dills Day 2 Schedule How can we prepare to recertify to the MDR? Is there an efficient, cost-effective way to train our team on the MDR? General obligations of the medical device manufacturer Uploading data and maintaining compliance with EUDAMED UDI in Europe and how it compares with US FDA UDI requirements and traceability of the supply chain Classifying medical devices under the European MDR Conformity assessment procedures and the role of Notified Bodies Safety and performance requirements Navigating standards under 2017/745/EU Clinical evaluations and new rules on adequacy of clinical data and clinical investigations Clinical investigations and Clinical Research Organizations Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) Vigilance requirements for Europe Economic operator must verify that a previous economic operator has complied with the EU MDR requirements EU MDR importation and distribution requirements expand regulatory due diligence from legal manufacturer to importers and distributors The role of the Personal Responsible for Regulatory Compliance (PRRC) Planning your transition to the MDR Interactive Discussions Review Regulatory and Compliance Documentation Current Trends Debrief/Adjourn/Wrap-Up

7 2 Days Workshop on EU Medical Device Regulations Speaker:- David R Dills Price/Register 21-February-2018 To 22-February-2018 Burlingame, CA Seminar One Registration $ 1395 Special Group Discount Register for Four attendees $ 3885 Please call any of our customer support on to avail the below discount for your Group 2 Attendees - 5% off 3 to 6 Attendees - 10% off 7 to 10 Attendees - 15% off 10+ Attendees - 20% 0ff

8 2 Days Workshop on EU Medical Device Regulations Speaker:- David R Dills Some of our Testimonials David QU, senior Analytical Chemist Dalton Pharma Services. I learned a lot from the instructor and trainee good. Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals. Well placed, a lot of good information. Good interaction between participants.held at a good location." Evelyn Chang, Corporate manager Genzyme. Well delivered seminars, right place, good contents. Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc. The contents of the presentation and the discussion was very good" For GET IN TOUCH 3190 STIRLING ROAD Corporate Package Contact us UNIT K4,HOLLYWOOD,FLORIDA Call us! Toll Free