Sponsored by:
Complimentary Webinar
November 30, 2023 | 12:00 pm ET (US)
Real-World Evidence:
Not Just for PMCF
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REGISTER NOW!
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Join us for a panel discussion on use of real-world evidence in regulatory assessments. Get an up-to-date perspective on the key concerns, benefits, challenges and approaches that manufacturers must consider when using real-world evidence to meet their regulatory submission requirements.
WHO SHOULD ATTEND:
- Quality, Regulatory, Engineering, Software and R&D staff who are involved in the preparation and entry into the European Market
WHAT YOU WILL LEARN:
- MDR Requirements
- When a Clinical Evaluation of Software is required
- Guidance Document MDCG 2020-1
- The Clinical Evaluation Process for MDSW
- Introduction to the EU AI Act
SPEAKER
Dr. Bassil Akra
CEO & Owner
AKRA TEAM GmbH
Dr. Bassil Akra is CEO & Owner of AKRA TEAM GmbH, a consultancy company supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Dr. Akra spent many years as a subject matter expert as well as the Head of Clinical for TÜV SÜD Product Service GmbH. Dr. Akra also served as the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.
Dr. Bikas Arya
Integrated Clinician & Principal Assessor
DNV Product Assurance
Dr. Bikas has 15 years combined experience in clinical practice, and clinical research (relevant to pharmaceutical/medical device). Past background in leading government and industry-sponsored collaborative clinical research projects within academia. Unique educational background: Degree in Medicine, Master’s in biomedical engineering, Doctoral research in Clinical Research. Extensive experience with medical devices risk management, quality management systems, and regulatory affairs. Routinely conducts audits for ISO 13485/QMS including MDR. Has a strong track record of publishing in reputed scientific and medical journals. In past served as a reviewer and editor for reputed Journals/conferences. Presented and contributed at various international conferences in the UK, USA, India, Canada, Australia, and Austria.
Robert Dostert
Sales Manager Medical Devices
DNV Business Assurance AS
Robert has 20 years of experience in the Healthcare industry. At DNV, Robert collaborates with a team of more than 250 experts, who serve the medical device industry worldwide. Robert is driven to ensure DNV's clients are provided quality services including assessments, CE Marking, software tools, training, and technical expertise to successfully bring their products to the healthcare market in a safe and timely manner.
Diane Legere
Sr. Clinical Auditor
DNV Business Assurances AS
Diane has 30+ years’ experience in the healthcare industry. She is an Advanced Practice Nurse with over 15 years clinical experience in the Critical Care setting. Her experience in industry includes building quality management systems, product safety, education and training. For the past 3.5 years she has been a Notified Body clinical reviewer.
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