Speaker Profile
GRAEME LADDS
Graeme Ladds, Director of PharSafer, has over 30 years 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 top ten Pharma Companies. The last twenty one years have been spent in his consultancy company, PharSafer Associates Ltd, a niche CRO specialising 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 which enhances case processing accuracy, speed and provides cost savings for Companies serious about safety.
Graeme Ladds
December 03 2024
12 : 00 PM EST
60 Minutes
Pharmacovigilance Inspections
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..
Graeme Ladds
January 07 2025
12 : 00 PM EST
60 Minutes
Risk Appraisals for Internal Audits in Pharmacovigilance
The audit program is an essential part of the QMS for the Company and prioritizing the scheduling and content of the audit is critical to the success of assessing the Company's compliance in preparation for a Regulatory Inspection.The course will look at the Regulatory Inspections of the audits and how the Company can justify the approaches taken in terms of Risk.The course will also detail those routine as..