Drug Safety Medicine

Expert training  in medical and scientific aspects of Drug Safety & Pharmacovigilance

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.

Helping you make Drug Use Safer

Safety Matters more & more. Are you ready?

get ready, to be ready, to stay ready

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.

Are you ready as medical expertise and scientific acumen are gaining greater prominence in Drug Safety and Pharmacovigilance (PV)?

DrugSafetyMedicine helps you get ready, be ready and stay ready 

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 - 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