For those attending the upcoming Health Sciences Records and Archives (HSRAA) Annual Conference, being held in Brighton, UK between 25th and 27th April 2018, there is the opportunity to hear from a Medicines and Healthcare products Regulatory Authority (MHRA) speaker, as well as a speaker from the National Institute for Health and Care Excellence (NICE).
During the Regulatory Focus session, Emma Whale, a Senior GLP and GCP Inspector of the MHRA will speak about ‘Regulatory Aspects of Managing of GxP Records’. In this overview, Emma will look at such areas as legislation, regulation, inspections and expectations, as well as provide a Regulatory update.
After which, Boglarka Mikudina, a Technical Analyst at NICE will delve into ‘Data and Evidence Requirements for Health Technology Evaluation at NICE’. Starting with an introduction to the work of NICE, Boglarka will also look at the evidence requirements of health technology evaluation.
Closing out the Regulatory Focus session, attendees will be able to participate in a Regulatory Q&A Panel Session. This is your opportunity to question the regulators on any aspect of GxP records management and the regulations.