Dealing with uncertainties in pharmacovigilance & PRAC procedures in the new era


Published 10 July 2019



Doris I. Stenver, MD, MPA

Independent Pharmacovigilance Adviser

Founder of Unique Advice


This summer it is 7 years ago the EU Pharmacovigilance Risk Assessment Committee (PRAC) was established, as the 2012 pharmacovigilance legislation entered into force. The creation of the PRAC marked an important milestone in pharmacovigilance history. The legal basis for pharmacovigilance was strengthened and extended, and so was the mandate and power of the pharmacovigilance committee. As a direct consequence of this significant change of the legal frame for EU pharmacovigilance all stakeholders – industry employees as well as regulators – had to work hard to familiarize themselves with an abundance of new procedures. For none of us, it was “business as usual”.

Despite the fact that PRAC has existed for several years, the way the PRAC works seems to be largely unknown by many industry employees. This is my own observation obtained while working as a consultant together with colleagues in pharmaceutical companies, where I provide advice on how a company can best fulfill its obligations, e.g. in relation to creation of the pre-authorisation risk management plan or how to provide adequate responses to questions raised by PRAC in e.g. a referral, signal or PSUSA procedure.

There seems to be a lot of uncertainty regarding how the PRAC operates in detail. In a recent example where I assisted a company to respond to questions raised by PRAC during a procedure, I discovered, that there was a need to explain some basic details. How is the preliminary assessment report prepared by the regulator? Which strategy should the company apply in responding to questions raised by the assessor? How is the procedure dealt with during the PRAC meeting? When will there be a need for requesting an oral explanation? And how is an oral explanation organized?

This uncertainty and lack of knowledge is problematic as it jeopardizes the important cooperation between 2 key stakeholders – the pharmaceutical industry and the regulatory authority. In a company perspective, it can mean a huge difference with regard to the ultimate conclusions on a products safety profile. And most importantly - for the sake of the patients it is extremely important that safety issues are dealt with in the best possible way. It is of key importance that decisions are sufficiently balanced and made on the basis of all available data. This can only be achieved through a joint action of industry and authorities. And only if there is a thorough understanding of how PRAC operates, it will be possible for the industry stakeholder to fulfill its obligations and to deliver adequate assessments and other responses of sufficiently high quality.

This is the background why I – together with the Fleming group – in September 2019 launch the first advanced training course dedicated to the activities covered by the PRAC mandate. During this course, I will share my experiences gained during almost 7 years as a PRAC delegate, a position I had while I was Chief Medical Officer at the Danish Medicines Agency. During this course, I will provide an overview of the entire PRAC mandate, through a combination of insightful presentations and engaging and interactive workshops.