This course presents the regulatory environment for the pharmaceuticals industry along with numerous directives, regulations and guidelines. During this 2-day course you will have the opportunity to learn pharmacovigilance working on case studies. At the end of the course you will produce practical advice and develop adequate strategies to handle reporting requirements.
You will learn how collect and report adverse events and safety data and manage the risk associated with risk to your products. This unique format will provide you with the key skills and knowledge needed to operate a fast, effective drug safety programme.
WHAT YOU WILL LEARN
How to effectively monitor your drug safety profile and avoid inspection findings
Risk and post-marketing issues that can negatively impact your drug sales revenue
Recognising key signals over time and take corrective and preventive action
EU requirements: Directives, regulations and guidelines
Compiling and presenting key information to reduce errors of interpretation
Prepare PSURs or PBRERS – when and how to change
WHO SHOULD ATTEND
Heads, Directors, Senior Managers and Managers of:
Pharmacovigilance, Pharmacology, Pharmacoepidemiology, Risk Management, Drug Safety, Signal Detection, Data Mining, Benefit/Risk Assessment, QPPV, Medical Affairs, Medical Information, Regulatory Affairs, R&D, Clinical Safety, Quality Assurance, Inspections, Audits, PSMF
PAST PROFESSIONAL TRAININGS