Pharmacovigilance Inspections
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Speaker : GRAEME LADDS
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When : Tuesday, December 03, 2024
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Time : 12 : 00 PM EST
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Graeme Ladds, Director of PharSafer, has over 30 years of experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1990 and becoming Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals and has also served as EU QP PV at many top ten Pharma Companies. The last twenty-one years have been spent in his consultancy company, PharSafer Associates Ltd, a niche CRO specializing in performing pharmacovigilance for many Companies around the world. During this time, Graeme has been involved in establishing Pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP PV for companies, and helping with regulatory inspections.
Graeme is
also the inventor of RAPTAR – an automated safety case processing tool
that enhances case processing accuracy, and speed and provides cost
savings for Companies serious about safety.
Regulatory inspections are the end result of the Company QMS assessment. Companies and Sponsors of trials need to have performed audits on all regulatory aspects to ensure compliance before the Regulatory Authorities assess with an inspection.
This course will cover how the Regulatory Agencies interact with Companies, what they will look for and expect, the grades of findings, and what happens next after the inspection and report.
The course will also cover how to prepare for the inspection.
Areas Covered
- The Company QMS
- Inspection gradings, including finding upgrades when cumulative
- CAPAs and approvals
- Risk analysis of findings
Who Should Attend
- PV Compliance
- Head of Regulatory
- EU QP PVs
- Director/Manager of Pharmacovigilance
- PVQA
Why Should You Attend
The reason for attending this talk is to understand where the Regulators will focus their attention when it comes to inspections involving pharmacovigilance activities from individual report production and reporting to signal detection; benefit-risk and risk minimization programs.
The focus will be on what processes are in place, training for individuals, database systems, etc… and this will involve Clinical; Regulatory; PV; IT; and QA Departments.
Serious Regulatory findings can cause clinical trials to be stopped/delayed; product suspensions; large Company fines and further Regulatory scrutiny.
Topic Background
Pharmacovigilance inspections are becoming increasingly more of a global occurrence. The sharing of such inspection reports between the various Regulators is again increasing, allowing Regulators to know if Sponsors of Clinical trials or license holders are in a compliant position regarding the safety of their products, which means that multiple inspections and findings can face those Companies that do not have robust internal audit programs and experienced auditors to keep them compliant.
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$199.00
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