This event will cover the two really key areas that all producers, recommenders and users of medical apps need to understand: medical device regulation and data privacy regulation...and we have two of the most knowledgeable people in the industry to guide us too - it will be a great evening!
Joe Hagan-Brown, Regulatory Affairs Specialist at the Medicines and Healthcare products Regulatory Agency (http://www.mhra.gov.uk/) (MHRA) has very kindly agreed to present on a huge range of app-related issues including:
The Medical Devices Directive - definition of a medical device; Software- qualification as a medical device; A brief background to software in the context of medical device legislation; Meddev 2.6/1; The market for Apps; MHRA guidance on software as a medical device; Five categories of apps; Classification; Conformity assessment; Telehealth; Vigilance/Post market surveillance; General requirements; Specific considerations
Alex Denoon, from Lawford Davies Denoon has kindly agreed to talk to us on the Impact of the proposed Data Protection Regulation on biomedical research. The talk will cover the (largely unintended) potentially catastrophic effects on matters are diverse as biobanks, personalised medicine, e-health and the development of new medicines.
The plan is to give both speakers plenty of time both for their presentations and to respond to questions, so for this event there will be just the two, plus the pitch spots (below).
Please aim to arrive by 6.15pm; we will start at 6.30pm and will end by 8pm giving ample time to enjoy Baker Botts' generous hospitality before we leave at 9pm.
We have just one pitch:
Joao P. Bocas - a Wellness app