Adequate safety is a prerequisite for any medicinal product. To manage safety well requires a broad range of medical/clinical and scientific/statistical skills. On-going learning and education is essential to navigate the sometimes treacherous waters of clinical development and in-marketing safety. Let drug safety medicine be you lighthouse, protecting you from hidden perils to bring you safely to your harbor.
Providing subject-matter Mentoring & Tutoring, Workshops & Seminars, On-line learning: access to specialized actionable knowledge, as you need it, when you need it and how you need it.
An invaluable resource for managing safety smartly and safely to shorten time to market, reduce development cost, increase long-term market-share, and manage safety obligations wisely.
Safety matters to stakeholders. With an increasing number of bio-pharmaceuticals to choose from comes distinction. Differences in perceived safety impact product uptake. Managing safety well is a business-critical investment.
Tailored medicine is here today. Patients and healthcare providers are expecting information to customize therapies, also in terms of safety. Companies are challenged to support personalized risk assessments.
Society has become risk averse. Hesitancy toward vaccination during the pandemic is illustrative. Actively shaping the clinical safety profile and communicating it reassuringly are essential to a product's success.
Medical and scientific topics have moved up the list of inspectorate priorities. Inspectors are asking for detailed discussions of the medical safety evaluation. Sound reflected medical reasoning is expected.
Well-managed clinical trial safety carries forward into the entire life cycle. Choosing exclusion criteria wisely, being selective in safety assessments and monitoring safety diligently, protects patients and products. Clinical acumen is essential.
Demands on the medical safety information provided in marketing authorization applications (MAA) - i.e. Section 2.7.4 of the CTD are not waning. Building a compelling evidence-based case is non-negotiable.
Regulators expect proactive management of risks. Risk Minimization Measures (RMM) / Risk Evaluation and Mitigation Strategies (REMS) require reflected and robust expert clinical input.
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 - filtering the noise to hear clearly
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 - a solid evidence-based story-line
The Risk Management Plan - keeping obligations measured
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 - effective & efficient designs
Safety inspection & audit readiness - an attitude and a practice
Safety communication - it's what you say and how
In-licensing safety review - leaving no stone unturned
Managing early in-market clinical safety - a sensitive period
Late life-cycle safety - leveraging history, weight of the prior