MDR Summit Tokyo
About
Date/Time
Date(s) - June 11, 202410:00 AM - 04:00 PM JST
Location
Nihonbashi Life Science Building2 Chome-3-11 Nihonbashihoncho, Chuo,
Tokyo, 103-0023
NOTE: IN-PERSON TRAINING,
LIVE TRANSLATION IN JAPANESE
MDR Summit
Date: 11 June 2024
Location: Nihonbashi Life Science Building
Price: $200 USD
NAMSA is delighted to be back in Tokyo for another MDR summit, led by one of our foremost experts on MDR: Adrian Keene, Associate Vice President of Global Biological Safety & Validation and EMEA Consulting Services (for more information, please review the Speaker information below). Joining him will be Sara Finocchietti, Senior Strategy Consultant, Clinical, bringing a wealth of experience of EU Post Market Clinical Follow-Up (PMCF) study implementation.
This half-day summit provides practical solutions for navigating the European Union Medical Device Regulation (EU MDR), including a dedicated session on developing and implementing PMCF strategies, with case studies. Designed for professionals in the medical device industry, this course will equip you with the knowledge and skills you need to successfully implement the EU MDR requirements in your organization.
Please review the Agenda below for further information.
Attendees will have the opportunity to ask questions during the interactive Q&A session, as well as extensive time available in the afternoon to discuss with our experts.
MDR Summit
日付：2024年6月11日
所在地 日本橋ライフサイエンスビルディング
価格：200ドル
NAMSAは、MDRの第一人者であるエイドリアン・キーン氏（スピーカーの詳細については、ページをスクロールしてください）を講師に迎え、今年も東京でMDRサミットを開催する運びとなったことを嬉しく思います。さらに、EUにおける市販後臨床フォローアップ（PMCF）試験実施に関する豊富な経験を持つ、シニア製品開発ストラテジストのサラ・フィノッキエッティが加わります。
この半日のサミットでは、欧州連合医療機器規制（EU MDR）をナビゲートするための実践的なソリューションを提供します。このコースは、医療機器業界のプロフェッショナルを対象としており、EU MDR要求事項の導入を成功させるために必要な知識とスキルを身につけることができます。
対象となるトピック
MDR移行期間の延長に伴う更新と影響
EUのデバイスポートフォリオをMDRに移行するための運用上の考慮点
ノーティファイドボディから観察された欠陥やフィードバックからの学び
市販後調査（PMS）および市販後臨床フォローアップ（PMCF）要件への実践的アプローチ
エイドリアン・キーンとサラ・フィノッキエッティがご相談に応じます。
なお、ネットワーキング・セッションは途中退出も可能です。
NOTE: Our security measures require that your credit card billing address match your profile address.
*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com.
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MDR Summit Tokyo
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10:00 – 10:30
10:30 – 12:00
- Update and implications of the extension of the MDR transition period MDR
移行期間延長の最新情報と影響 - Key considerations for transitioning your EU device portfolio to the MDR EU
のデバイスポートフォリオをMDRに移行する際の主な検討事項 - Experience from deficiencies and feedback observed from notified bodies
欠陥から得た経験および通知機関から観察されたフィードバック
12:00 – 13:00
13:00 – 15:00
- Post market surveillance (PMS) and post market clinical follow up (PMCF) requirements
市販後調査（PMS）と市販後臨床フォローアップ（PMCF）の要件 - Developing your PMCF strategy to meet both your business and EU regulatory requirements
貴社のビジネス要件とEU規制要件の両方を満たすPMCF戦略の策定 - Practical considerations for implementing your PMCF strategy PMCF
戦略を実施するための実践的な検討事項 - Case studies in PMCF implementation PMCF
実施のケーススタディ - (including Q&A)
(Q&Aを含む)
15:00 – 16:00
Adrian Keene and Sara Finocchietti will be available to discuss.
エイドリアン・キーンとサラ・フィノッキエッティが話し合いに応じる。
Please note that you can leave before the end of the networking session if you need to.
ネットワーキングセッション終了前にご退出いただくことも可能です。
Speaker
Adrian Keene, BSc (Hons)
Associate Vice President of Global Biological Safety & Validation and EMEA Consulting ServicesAdrian has more than 30 years of experience in product development and registration within the medical device industry, with manufacturer, regulatory agency, and consultancy perspectives. Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced and pragmatic interpretation of the needs and expectations of both regulators and manufacturers. Before working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS and spent 10 years in the Notified Body sector, where he was responsible for conformity assessment activities of high-risk (class III) devices under the Medical Device Directive (MDD).
He is a toxicologist by training and worked for several years in the Research and Development (R&D) sector of the medical device industry, providing toxicological and risk management strategies to expedite product launches for multiple global registrations.
Sara Finocchietti
Senior Strategy Consultant, ClinicalSara Finocchietti has over 15 years of experience in the medical device industry with a wide range of therapeutic areas. Her core focus has been on orthopedics, neurovascular and neuroscience. Her career started in academia developing innovative medical devices and providing clinical and regulatory strategy. Her previous experiences include working as a Clinical Affairs Manager at a French manufacturer with a full orthopedic portfolio, defining the strategy to transition to the EU’s Medical Device Regulation (MDR).
Sara holds an MSc in Biomedical Engineering from the University of Genoa (Italy) and a PhD in Clinical Science from Aalborg University (Denmark).