Course library
On-demand courses
Drug Safety & Pharmacovigilance (PV) for non-specialists
The Logic of Clinical Safety - the why behind the how
Methods of Clinical Safety - a primer into tools & techniques
Medical Writing for Clinical Safety - what matters most
Clinical Safety in the Clinical Development Plan (CDP)
Clinical Safety in the Investigators Brochure (IB)
First in Human (FIH) Transition - safety first
Clinical Safety in the Clinical Trial Protocol (CTP)
Safety Monitoring of Clinical Trials - keeping a watchful eye
Data Safety Monitoring Boards (DSMB) - as one team
Safety in Numbers - letting the data speak
Making Sense of Safety Data - conditional probabilities
Visualizing Safety Data - informative images
Clinical Hold & Safety - turning it around
Reporting Safety in the Clinical Study Report (CSR) - be clear
Presenting Clinical Safety Data - give context & meaning
Evaluating Clinical Benefits & Risks - toward a balanced view
Bayesian Thinking in Clinical Safety - know how, do now
Dealing with Difficult Safety Data - think forest not trees
Modelling & Simulation in Clinical Safety - a hidden gem
Risk Minimization Measures (RMM) - fit for purpose
Clinical Safety in the Dossier - planning, writing, reviewing
Product Safety Labeling - of proportionality & measure
Health Authority (HA) Safety Questions - answering them well
Post Authorization Safety Studies (PASS) - design & conduct
Risk Evaluation & Mitigation Strategies (REMS) - on target
Inspection & audit readiness - a mindset and a practice
Signal Detection & Evaluation - the message above the noise
Safety Communication - of clarity and credibility
Clinical Safety In-licensing Review - turning over every stone
Off the shelf
A stock of courses and modules pertaining to key topics in drug safety and pharmacovigilance is available on-demand.
Each ready-made course can be further tailored to your specific needs by including examples and case studies from your own organization or pertaining to a particular therapeutic area or drug class.
Courses may be provided face to face, as live video conferences or as video recordings to be viewed on-demand.
In addition, all course topics may be expanded upon and provided as masterclass seminars that take the topic to the next level.