Course library
A contemporary lighthouse guiding you to a new sunrise
Safety Matters more & more. Are you ready?
Enjoy teaching that captivates, and inspires. Sense an enthusiasm that fuels learning and motivates to apply.
Each 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.
Curriculum topics
Drug safety for non-specialists - a brief introduction
Drug safety for specialists - its deeper logic, the why and how
Methods of drug safety medicine - tools and techniques
The safety profile is what you make it - your actions matter
Medical writing for clinical safety - thoughtful, balanced narrative
Clinical safety in the Clinical Development Plan - strategy counts
Safety in the Investigators Brochure - targeted safety science
First in Human transition - safety first: right the first time
Safety in the Clinical Study Protocol - a coherent approach
On-study clinical safety monitoring - being vigilant and diligent
Making sense of clinical safety data - finding safety in numbers
Statistical methods in drug safety - what you see is not the truth
Making sense of laboratory safety data - a systematic approach
Visualizing safety data - making a picture worth a 1000 words
Signal detection & evaluation - of wheat and chaff
Emerging safety information - from blurry image to sharp photo
Data Safety Monitoring Boards - as one team
Revisiting toxicology - mechanisms matter
Safety Clinical Hold - moving from liability to asset
Safety in the Clinical Study Report - coherent inclusive clarity
Presentations on clinical safety data - the message that is heard
Evaluating benefits vs risks - simplicity beyond complexity
Dealing with difficult safety data - finding the silver lining
Bayesian Methods in drug safety - a powerful tool
Modelling & Simulation in drug safety - extending your reach
Risk Minimization and Mitigation - actively shaping clinical safety
Clinical safety in the dossier - planning, writing, reviewing
Avoiding a vulnerable dossier - of reasoning and reasons
The Risk Management Plan - doing what matters
Product safety labeling - of proportionality and measure
Avoiding unfavorable labeling - giving context & perspective
Health Authority questions - put yourself in their shoes
Post Authorization Safety Studies - the devil is in the detail
Safety inspection & audit readiness - quality by desire
Safety communication - how matters (as much as what)
In-licensing safety review - becoming Sherlock Holmes
Early in-market clinical safety - staying on your toes
Late life-cycle safety - leveraging history, weight of the prior