Pharmacovigilance for Lawyers Course
Causality Assessment, Risk Benefit Evaluation & Pharmacovigilance Communications
ONLINE TRAINING | 15 Oct 2026 | Professor Saad Shakir & Dr Sarah Hall
A long overdue pioneering course,
led by two top pharmacovigilance experts
Professor Saad Shakir
Consultant Pharmacovigilance Physician & Pharmacoepidemiologist
ADROITVIGILANCE
Dr Sarah Hall
Pharmacovigilance Expert
Managing Director Mipsol Limited
About the Course
Many medical negligence and personal injury lawyers, as well other legal professionals do not fully understand how pharmacovigilance works. This one‑day course fills the gaps, it provides for the with a clear understanding of how pharmacovigilance (drug safety monitoring) works within pharmaceutical companies and regulatory authorities. The course is delivered by two top pharmacovigilance experts.
Causality assessment
Risk/ benefit evaluation
Decision making
Managing uncertainties
Pharmacovigilance communications
The topics are of interest to lawyers, such as:Designed specifically for:
Practising solicitors and barristers
In‑house company lawyers
Government and public‑body lawyers
Legal professionals supporting the pharmaceutical sector
The programme blends scientific principles with real‑world operational and regulatory considerations to enable lawyers understand how pharmacovigilance works, how decisions for causality and risk/assessments are generated, the time needed for decisions to be made and how the safety information is communicated.
Course Objectives
Understand how adverse event reports are processed and assessed
Gain insight into pharmacovigilance causality methods, including the Bradford Hill criteria
Distinguish between legal and pharmacovigilance approaches to assessing causation
Recognise how labelling, safety communications and risk‑minimisation strategies are developed
Learn about practical issues where legal and pharmacovigilance teams must collaborate
The presentations will illustrate some legal implications of pharmacovigilance
The course will include a discussion about the medical and legal perspectives of drug safety and opportunities for Q&A
By the end of the day, participants will:One-day Online Course for LawyersCourse Program
Master the operational and legal fundamentals of drug safety with this intensive online training course led by industry leaders Prof. Saad Shakir and Dr. Sarah Hall. Designed for pharmacovigilance professionals, regulatory affairs specialists, and legal counsel, this comprehensive program traces the complete journey of an Adverse Event (AE) from initial receipt to regulatory reporting. Key technical topics include causality assessment, the Bradford Hill criteria for causal inference, signal detection and management, Designated Medical Events (DMEs), Events of Special Interest (ESI), and risk minimisation strategies.
Attendees will gain practical knowledge on product labelling, managing uncertainty in pharmacovigilance, and issuing Direct Healthcare Professional Communications (DHPC). Featuring real-world case studies on legal collaboration and an interactive panel on Adverse Drug Reaction (ADR) causality, this masterclass provides the essential regulatory framework and cross-functional insights required for effective drug safety compliance and litigation risk management.
Course fees:
Standard rate fee: £780.00 | Public Sector, academia, and charities: £480.00
Early bird registration before 4 September: £680.00 and £420.00
10% discount for additional staff from the same organisation