MDR Summit Tokyo
About
Date/Time
Date(s) - May 16, 202310:30 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: 16 May 2023
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, BSc (HONS); Associate Vice President of Global Biological Safety & Validation and EMEA Consulting Services (for more information, please review the Speaker information below).
This half-day summit provides practical solutions for navigating the European Union Medical Device Regulation (EU MDR). 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 for one to one discussion sessions with our expert.
If you would like to schedule a more formal consulting session with Adrian, please contact your Account Manager.
MDR Summit
日付：2023年5月16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。
この半日サミットでは、欧州連合医療機器規制（EU MDR）を円滑に進めるための実践的な解決策を提供します。医療機器業界のプロフェッショナル向けに設計されたこのコースは、EU MDRの要件を組織で成功裏に実施す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
参加者はインタラクティブなQ&Aセッションで質問できるほか、サミット終了後に専門家と20分間の1対1のディスカッションを予約することができます。参加人数は限られていますので、お早めにお申し込みください！
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
- Operational considerations to ensure you can transition your EU device portfolio to the MDR
- (incl Q&A)
12:00 – 13:00
13:00 – 14:30
- Learnings from deficiencies and feedback observed from notified bodies
- Practical approaches to post market surveillance (PMS) and post market clinical follow up (PMCF) requirements
- (incl Q&A)
14:30 – 16:00
Adrian Keene will be available for one to one discussions
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.