Adverse Event Reporting & Pharmacovigilance
Course Objectives
Product recall is a real disaster, especially when it could have been avoided through accurate drug safety reports and quick reaction to postmarket safety issues. Industry cannot afford to waste the investments made in the clinical and marketing activities of new products through poor ADR reporting practices.
This course will review the regulatory environment in which you operate and will guide you through the vast number of Directives, regulations and guidelines. You will be given the chance to work on case study exercises to produce practical advice and develop adequate strategies to handle reporting requirements.
If you need to gain in-depth knowledge on the best way to prepare for, collect and report adverse events, then this is the course for you. Its unique format will provide you with the key skills and knowledge needed to operate a fast, effective drug safety programme.
Performance & Knowledge Objectives of this Course:
- Effectively monitor your drug reactions and avoid being blamed for negligence
- Minimise post-marketing issues that can adversely affect your drug sales revenue
- Perform accurate causality assessment to identify the exact origin of your ADRs
- Identify and follow up the key signals over time to take preventive actions
EU requirements: what are the Directives, regulations and guidelines and when do they apply? - Compile and present key information in your adverse event reports in a clear format and reduce errors of interpretation
- Examine the practical impact of global harmonisation: ICH and CIOMS
- Prepare periodic safety update reports (PSUR) within the required timeframe
What Will You Learn?
Dates and Venues
12 Apr 2010 - 13 Apr 2010
Regus Trafalgar Square, London, UK
19 Jul 2010 - 20 Jul 2010
Regus St James's Park, London, UK
21 Sep 2010 - 22 Sep 2010
Radisson Blu Royal Hotel, Brussels, Belgium
06 Dec 2010 - 07 Dec 2010
Regus St James's Park, London, UK
Who Should Attend
Particularly suited to staff who have entered this field in the past two years and who need to develop an understanding of pharmacovigilance.
- Drug Safety / Pharmacovigilance Staff
- Regulatory Affairs Staff
- Anyone wishing to build or update their knowledge on adverse event reporting and drug safety information
- Clinical Development Staff
- Clinical Research Organisation Staff
Reviews
"The course was very well paced and detailed. I came away with a greater understanding of the pharmacovigilance processes and the course clarified a lot of 'grey' areas for me"
"Very comprehensive, well-presented and well-timed"
"Useful course which covered areas I was not previously familiar with i.e PSURs, signal detection and labelling"
Related Events
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
