An Introduction to Pharmacovigilance
In an informative and engaging virtual session, Joyce Bols kindly pre-recorded a comprehensive overview of pharmacovigilance (PV) and its central role in patient safety to the delegates of our 2025 Annual Conference.
About Joyce Bols
Joyce Bols is an experienced pharmacovigilance specialist with deep expertise in global safety systems, risk management, and regulatory compliance. As the UK and Ireland Pharmacovigilance Leader at Eli Lilly, her work supports the continuous monitoring of medicines to ensure patient safety throughout the entire product lifecycle. Joyce’s passion for education and cross-functional collaboration has made her a respected voice of the PV community.
About Eli Lilly
Eli Lilly is one of the world's leading biopharmaceutical companies, recognised for its long-standing commitment to advancing medicine, improving patient outcomes, and strengthening global drug safety systems. Through its research, regulatory leadership, and collaboration across the healthcare industry, Eli Lilly plays a pivotal role in shaping modern PV practices.
Session Summary: An Introduction to Pharmacovigilance
Joyce began by providing delegates with the World Health Organization (WHO) definition of pharmacovigilance:
"Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.”
Joyce highlighted that PV is not solely the responsibility of the Marketing Authorisation Holder (MAH). Instead, every participant in the supply chain plays a role, from manufacturers, wholesale distributors to pharmacies, hospitals, healthcare professionals and ultimately, the patient. The overarching aim is simple yet critical: To minimise risk and maximise benefit for the patient.
Understanding PV Technology
Joyce clarified several important PV concepts that form the foundation of safety reporting.
Adverse Event (AE)
An untoward medical occurrence that happens after the administration of a medicine without a causal relationship.
Example: A patient takes a medication, then later has a fall unrelated to the drug.
Adverse Reaction (AR)
A harmful and unintended response with at least a possible causal link to the medicine.
Example: Nausea after taking a particular dose.
Other Safety Information
PV obligations go far beyond EAs and ARs. Wholesalers and MAHs also monitor and report information such as:
- Use in pregnancy
- Overdose or accidental exposure
- Lack of efficacy (potential indicator or falsified medicine)
- Off-label use
- Withdrawal symptoms
- Drug interactions
- Occupational or environmental exposure (e.g. spillages, broken vials, vapour exposure)
- Unexpected therapeutic benefit
Joyce explained that the breadth of data gathered helps to ensure a robust safety profile for every medicine on the market.
A Brief History of Pharmacovigilance Regulation
Joyce informed the delegates of a timeline of how PV systems have evolved in response to global public health needs:
These milestones demonstrate how PV has become increasingly structured, data-driven, and internationally aligned.
Wholesaler Obligations in PV
Joyce reinforced that GDP regulated wholesalers are a vital source of safety information.
Their responsibilities include:
-
- Reporting ALL AEs and ARs to the MAH
- Communicating any product quality complaints promptly
- Being prepared for audits as part of MAH’s wider pharmacovigilance system
- Ensuring a Master Service Agreement (MSA) is in place to define safety-related duties and reporting pathways
She emphasised that wholesalers often serve as the first observation point for unusual product behaviours, storage issues, or customer feedback, making their vigilance essential.
Why This Matters
Joyce closed her session by reminding delegates that effective pharmacovigilance protects not only patients, but also the integrity of the entire supply chain. Clear reporting pathways, strong training, cross-functional awareness, and a collaborative mindset all contribute to a safer healthcare environment.
Her message was simple, but powerful:
“Pharmacovigilance is the shared responsibility of all!”
Conference Pricing
There are discounted tickets available for UK GDP Association members, members can save £100 when attending both conference days. However, our commitment to low-cost, high-value educational content means that conference tickets will still be the best value whether you chose to join as members or not.
Membership is only £29 +VAT per individual, per year and offers reduced costs on consulting, training and conference tickets. If you buy tickets for both conference days, there is an even greater discount. Costs for non-members is just £224.50 per day, a fraction of the cost of other industry events!
In addition, on the evening of Tuesday 16th June, we will be hosting an evening event of dinner, networking, and even some of Dave’s infamous karaoke, for just £49 +VAT per person. This is a fundraising dinner in aid of the MVA Society.
Please see here for more information on the conference and to book your conference and evening dinner tickets.
We are very much looking forward to seeing you all at the conference!
2025 Conferences
