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MHRA Inspector Balall Naeem to Speak at ACDM19

Date: September 10, 2018

The Association for Clinical Data Management are delighted to announce that Andy Fisher, Lead Senior GCP Inspector at the Medicines & Healthcare products Regulatory Agency (MHRA) will be a Keynote Speaker at ACDM19, The 2019 ACDM Annual Conference to be held in Amsterdam from the 11th to 12th March 2019.

Andy has a BSc (Hons) in Biology and a MSc in Medical Statistics and IT.

Andy worked as a Medical Statistician after gaining his MSc, being involved primarily in clinical trial design and data analysis. Andy also undertook some data management activities. After 3 years in this role, Andy moved into clinical research and became a Clinical Research Associate (CRA) at the start of 1996 and progressed to be a Clinical Project Manager. During these 7 years Andy was involved in a broad range of clinical trial activities for trials of pharmaceuticals and medical devices. Andy also had a part time role during his time as a CRA as an ISO9001 internal auditor. Andy’s last 2 years in industry prior to joining the MHRA were spent as Compliance and Training Manager within clinical research.

Andy has been with the MHRA GCP Inspectorate since August 2005 and has inspected numerous commercial and non-commercial organisations, contract research organisations, eSystems vendors, phase 1 clinical units and investigator sites as part of the MHRA and EMA inspections. Andy also conducts inspections of phase 1 unit as part of the voluntary phase 1 accreditation scheme. Andy was part of the authoring team for the MHRA GCP Guide. Andy also continues to work with EU GCP inspector colleagues in the EMA GCP Inspectors Working Group sub-groups on Quality Risk Management, TMFs and Source Data/eSystems that were responsible for the respective EU reflection papers and guidance documents.