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
October 23 2024
12 : 00 PM EST
60 Minutes
An Introduction to MedDRA and MedDRA Coding
MedDRA was introduced in the late 1990s. The aim was to unify the way that all aspects of medical terminologies for indications; lab data, signs, symptoms, and diagnoses were unified globally. Up until this time various different coding mechanisms were used – WHO-ART; HARTS; CO-START and others.Now with a unified system came the challenge of learning to code one way consistently and globally. This mea..
Graeme Ladds
November 18 2024
12 : 00 PM EST
60 Minutes
Quality Management Systems (QMS) and KPIs in Pharmacovigilance
Quality Management System (QMS) implementation in Pharma Companies is an expectation and a requirement from the legislation. QMS is not an extension of GMP which is the mistake made by a number of Companies. It is an over-arching system covering ALL of the Company's activities and not an offshoot of the GMP system.QMS is also seen as an activity that begins with, is approved by, and is sustained by Senior M..
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..