Webinar
EU and China Clinical Requirements
How to leverage clinical investigation data for CE marking
Description
Join our expert-led webinar tailored for companies worldwide seeking to obtain or maintain the CE marking for medical devices in Europe. This session is designed to provide a comprehensive understanding of the clinical data requirements necessary to support successful CE marking submissions under current European regulations and the options and requirements when considering to collect this data in China.
This webinar is an essential resource for companies aiming to streamline their clinical data strategies, navigate cross-border regulatory requirements effectively, and optimize their pathways for achieving CE marking compliance.
Net price
Free of charge
- Access to live webinar
- Chance to submit questions during included Q&A session
Purpose of the webinar
Participants will get:
- An overview of European clinical data requirements for CE marking
- Insights into the opportunities for conducting clinical investigations in China to meet these requirements
- A detailed discussion of data transferability considerations and the regulatory prerequisites involved
- Exploration of time and cost advantages associated with clinical data collection in China
Overview of covered topics
- Clinical data requirements for CE marking in the EU
- Can clinical data from China be used for EU submission?
- Why is it so important for Chinese medical device companies to obtain CE certification?
Who should attend
- Manufacturers
- Clinical Affairs Specialists
- Regulatory Affairs Specialists
Basic knowledge required
- A basic understanding of clinical requirements for medical devices
Presenting experts
Dr. Leslie Hammermüller
Senior Consultant
AKRA TEAM GmbH
Dr. Andrew Gibson
Team Leader - Senior Clinical Consultant
AKRA TEAM GmbH
Johnson Yang
Founder - CEO
Miracle Boost Limited (M&B)
Dr. Leslie Hammermüller
Senior Consultant
AKRA TEAM GmbH
Dr. Leslie Hammermueller is a senior consultant and project manager at AKRA TEAM GmbH. After graduating in human biology, she was a Clinical Data Manager for 10 years working on clinical studies in a global CRO before joining a medical device manufacturer as a Clinical Affairs Manager. In her current role at AKRA TEAM, she supports manufacturers of all device classes fulfilling the requirements of the EU — on the operational level as well as providing in-depth training — with a strong focus on clinical aspects.
Dr. Andrew Gibson
Team Leader - Senior Clinical Consultant
AKRA TEAM GmbH
Dr. Andrew Gibson is a senior consultant and team leader at AKRA TEAM GmbH. He is an experienced medical device regulatory affairs and quality management consultant. He has a background in microbiology, chemical characterization, and biotechnology. Working in Germany, Ireland and Canada, Andrew has had significant experience with EU, US, Canadian and other global regulations. Within these markets he has developed a unique skillset with a variety of medical devices from class I to class III. He has led project teams to identify gaps and update documentation helping manufacturers address the requirements of EU medical device regulation (MDR). He has specific expertise in clinical evaluation, post-market surveillance and technical documentation.
Johnson Yang
Founder - CEO
Miracle Boost Limited (M&B)
Mr. Johnson Yang, founder and CEO at Miracle Boost Limited (M&B). M&B is committed to providing full life cycle services for medical device manufactures in the pan-vascular field from China to go global. Main service includes regulatory registration, clinical and technical support, commercialization and so on. Mr. Yang has more than 20 years of management experience in the field of medical devices. Prior to founding M&B, Mr. Yang was the first marketing and sales manager at Edwards Lifesciences in China for THV business. During his service with Venus Medtech, he established China and international sales and marketing functions. During his time with Percutek Therapeutics, Mr. Yang served as director of international business.
Stephanie Schwenke
Senior Project Manager
Use-Lab GmbH
Dr. Anna Spehl
Senior Consultant
AKRA TEAM GmbH
Dr. Anna Spehl
Senior Consultant
AKRA TEAM GmbH
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