drugsafetymedicine.com

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 firstĀ 

  • 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 medicine 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.