General Data Protection Regulations in the EU
27 Min
1 Lesson
Price
Free
Lecturer
Danielle Giroud
MD-Clinicals SA, Switzerland
Founder, CEO of MD-Clinicals SA, Switzerland
With over 30 years of experience, Ms. Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO). Ms. Giroud is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe.
She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission – CIE (Clinical Investigation and Evaluation) task force.
With over 30 years of experience, Ms. Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO). Ms. Giroud is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe.
She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission – CIE (Clinical Investigation and Evaluation) task force.
Description
Applying GDPR to a clinical investigation is not new and clinical professionals are well aware of the main principles of GDPR, but are you really applying all aspects correctly? Are you familiar with a data protection impact assessment and what limitations GDPR may impose during remote monitoring? Are all data processors aware of their duties and how data are protected during centralised analysis or transportation outside of the EU? Answers should not be over-simplified or taken for granted. If running clinical investigations is your daily practice, then you will benefit from this practical review of GDPR requirements during EU medical device clinical investigations.
Related Courses
Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications
Nebojsa Serafimovic
BASG - Austrian Federal Office…
29 Min
1 Lesson
Free
Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies
Matteo Mosso
Donawa Lifescience, Italy
34 Min
1 Lesson
Free
Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR
Tom Melvin
Health Products Regulatory Authority (HPRA),…
22 Min
1 Lesson
Free
Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements
Daniela Karrer
Donawa Lifescience, Italy
46 Min
1 Lesson
Free
