This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing
25-27 Mar 2020
& 23-25 Sep 2020
GBP 1,849 1,549 *
EUR 2,589 2,169 *
USD 2,884 2,416 *
* When you book before 14 Feb
Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex range of safety and risk assessment activities to perform. This three-day course is designed for those with at least two years’ knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company.
Key topics to be addressed:
By attending this event, you will:
This course would be of maximum benefit to those safety professionals who are working both in the clinical and post–marketing safety arena including QA for auditing. The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.
Training for drug safety reporting duties
Audits and expectations
Compliance and drug safety
Interactive exercise: The requirements for a safety department
Product safety reviews – purpose and function
Interactive exercise: Designing the requirements for a safety review group
Safety reporting in licensing agreements
Developing CCSI – CIOMS III
Interactive exercise: Should new safety data from a clinical trial be put into core safety information?
PSURs and the revisions in ICH E2C
The EU Clinical Trials Directive
Interactive exercise: Reviewing the safety and risk-benefit of a product
Crisis management within drug safety
Interactive exercise: Deciding how to handle a major crisis within the company
Delegates will be split into groups and present what they need to have in place in order to effectively manage the crisis and look to its resolution.
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
|25-27 Mar 2020|
|25-27 Mar 2020||Rembrandt Hotel, London||GBP 1,849.00
+ VAT @ 20.00%
Until 14 Feb*
|23-25 Sep 2020|
|23-25 Sep 2020||Rembrandt Hotel, London||GBP 1,849.00
+ VAT @ 20.00%
* Note the early booking discount cannot be combined with any other offers or promotional code