Clinical Trials Regulation (EU) No 536/2014 Questions and Answers Document Version 7.3

Substantial amendments have been made to Chapter 7 on Safety Reporting, including the restructuring of Chapter 7 into distinct sub-chapters. Upon review, the comprehensive updates range from the total rewording of some questions and answers with little change in underlying principle, to the addition of new questions and requirements for safety reporting.

Tom NicholsOctober 7, 2026PHARMACOVIGILANCE, Clinical Safety, clinical trials

Compliance with Risk Minimisation Strategies – Expectations from Regulatory Authorities

Tom NicholsApril 30, 2024PHARMACOVIGILANCE CONSULTANT, PHARMACOVIGILANCE CONSULTANCY, PHARMACOVIGILANCE SERVICES, Risk Minimisation Plan, Risk Minimisation Activities, Additional Risk Mnimisation Activities

2020-21 MHRA PV Inspection Metric Report

From 01 April 2020 to 31 March 2021, the MHRA’s Good Pharmacovigilance Practice Inspectorate (GPvP) conducted 37 pharmacovigilance (PV) inspections on 36 marketing authorisation holders (MAHs) to evaluate its PV processes and compliance with existing EU and national PV regulations.

Tom NicholsOctober 13, 2022PHARMACOVIGILANCE CONSULTANCY, PHARMACOVIGILANCE SERVICES, PHARMACOVIGILANCE, GVP, Pharmacovigilance Consultant

The Role of AI in Transforming Pharmacovigilance in Clinical Trials

Utilisation of artificial intelligence (AI) to transform key steps in clinical trials to increase clinical trial efficiency, improve patient safety and the patient experience.

Tom NicholsAugust 5, 2021GVP, PHARMACOVIGILANCE CONSULTANT, PHARMACOVIGILANCE CONSULTANCY, PHARMACOVIGILANCE SERVICES, Pharmacovigilance, clinical trials, GCP

First Do No Harm

A pharmacovigilance perspective on the Cumberlege Report…

Tom NicholsJune 28, 2021Pharmacovigilance, GVP, PHARMACOVIGILANCE SERVICES, PHARMACOVIGILANCE CONSULTANCY

Move for Drive Phase PV

Tom NicholsSeptember 26, 2019

Patient Registries for PV

The evolution of patient registries for pharmacovigilance.

Tom NicholsNovember 27, 2018Pharmacovigilance, GVP, PHARMACOVIGILANCE CONSULTANT, PHARMACOVIGILANCE SERVICES, pharmacovigilance consultancy

4 Ways to Brexit-Proof your Pharmacovigilance System

A look at four areas where contingency plans are urgently needed to Brexit-proof your PV system.

Tom NicholsSeptember 26, 2018PHARMACOVIGILANCE, PHARMACOVIGILANCE CONSULTANCY, PHARMACOVIGILANCE CONSULTANT, GVP, PHARMACOVIGILANCE SERVICES, Pharmacovigilance BrexitComment

4 Ways to Optimise Clinical Development with Pharmacovigilance

A look at four areas where increased cross-functional collaboration and understanding can yield benefits, both immediately and also downstream.

Tom NicholsAugust 24, 2018PHARMACOVIGILANCE, PHARMACOVIGILANCE CONSULTANCY, PHARMACOVIGILANCE CONSULTANT, GVP, GCP, Pharmacovigilance Services Comment

PV and Social Media- The Full Article

Very grateful to PIPA allowing me to publish the full article here, so non-members can see it.

Tom NicholsJune 22, 2018PHARMACOVIGILANCE, PHARMACOVIGILANCE CONSULTANCY, PHARMACOVIGILANCE CONSULTANT, GVP, GCP, Pharmacovigilance ServicesComment

Sodium valproate and Safety Communication

Sodium valproate has been in the news recently due to its links to birth defects and the pregnancy prevention programme (PPP), introduced in April 2018, to limit its use in women and girls of child bearing potential. These risks were known when I first started working in PV, over 10 years ago, so I was surprised to see it making such big headlines. How has a well-established side-effect only recently come to the public attention, casting the industry in further bad light? This is not a piece about sodium valproate specifically, but rather the general process of risk management and communication between the industry, regulators and the public.