On Thursday 23 April 2020, 15:00 BST, 16:00 CEST & 10:00 EDT, Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group, will discuss current best practices and opportunities for future improvement in oncology safety processes.
Oncology has seen tremendous advances in treatments with impressive results for some previously incurable solid cancers. This is best illustrated by immunotherapies such as immune checkpoint inhibitors. In addition, the use of predictive biomarkers helps identify patients who may truly benefit from treatment.
To maximise benefit of these therapies, we need to enhance pharmacovigilance. We are all keen to ensure pharmacovigilance work transforms from volume-based operations to value-based work through effective use of technology to allow automation and machine learning without comprising quality and early risk detection.
The use of accelerated procedures for regulatory approval means more and more that real world evidence gathering and assessment is deferred to the post-authorisation phase, putting more responsibility on pharmacovigilance professionals.
The webinar will focus on:
- How best to increase operational efficiency using technology and the consistency of data quality when processing ICSRs, including applying severity grading and collecting patient reported outcomes
- Novel approaches to signal detection when faced with large amounts of data
- How best to manage off label use and medication errors
- Planning for risk management of immunotherapy-related toxicity, which can be variable, occurring at any time throughout treatment or even after completion of treatment
To learn more about NDA’s Pharmacovigilance specialists and services click here
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About the Speaker
Brian has a BSc (Hons), M. B. B.S., MRCP, MD. and is a GMC registered physician with previous experience in hospital, renal medicine and clinical research, as a pharmacovigilance assessor in the UK regulatory authority (MHRA), clinical trials and post-marketing pharmacovigilance in a global CRO, deputy QP for pharmacovigilance at Johnson & Johnson. He joined NDA in 2007 and specialises in PV quality management and all aspects of safety compliance, risk management, QP for pharmacovigilance services, clinical trial safety.
In addition, Brian is Director of ISoP Secretariat Ltd and co-chairs the ISOP Medication Error Special Interest Group, Vice President Pharmacovigilance & Drug Safety in the Alliance Clinical Research Excellence and Safety (ACRES) and Chair of the UK Pharmaceutical Human Factors group.