1st July, 2021

Dear ISoP Members,

Following President Mira Harrison-Woolrych’s address to the ISoP General Assembly in October 2020, we are pleased to report that the Scoping Group has suggested two ways forward for the future development of ISoP. These proposals have been approved by the Executive Committee and the Advisory Board, and are now being shared for consultation with all ISoP members.  

WHY we need change

ISoP is financed through membership fees, with recruitment of members largely through annual meetings and training courses. The Covid-19 pandemic has removed in-person meetings and has impacted recruitment of new members. The ISoP leadership team asked the Scoping Group to consider alternative operational models for our society, to sustainably increase membership, while continuing to deliver high class international education and training in pharmacovigilance.

WHAT we want to achieve

The Scoping Group formulated two strategic objectives:

To improve wider recognition of ISoP as a scientific society with respected authority in pharmacovigilance education.
To allow ISoP to offer a professional development program with relevant qualifications, for those working on pharmacovigilance worldwide. 

HOW we want to achieve it

The Scoping Group paper (attached) suggests two complementary actions:

1.     Establishment of an ISoP Scientific Board

The ISoP Scientific Board would develop educational strategies and training content, provide scientific advice on international pharmacovigilance matters and engage in related initiatives. The Scientific Board would operate independently from the ISoP Advisory Board, reporting directly to the ISoP Executive Committee. Detailed proposals for an ISoP Scientific Board, including the Terms of Reference for the new committee, are in the attached Scoping Group paper.  

2.     Establishment of a Global Pharmacovigilance Professional Certification program

The Global Pharmacovigilance Professional Certification (GPPC) is being developed jointly by the ISoP Special Interest Group (SIG) on Pharmacovigilance Career Framework and the Institute of Pharmacovigilance, a non-profit organization for enhancing pharmacovigilance as a profession. 

Three major steps are proposed for the GPPC:

1.     Development of an ISoP Standard on Career Framework, including definition of roles and guidance on seniority levels (where relevant) in the pharmacovigilance profession.

2.     Development of an ISoP Standard on Competence expected in each pharmacovigilance role.

3.     Development of a certification program testing the competence of candidates against ISoP standards.

It is hoped that a GPPC certificate will assist PV professionals to progress more confidently in their career. Being available to ISoP members only, the program should also increase membership and the perceived value of membership for current and future members. By improving the competence of pharmacovigilance professionals, ISoP hopes to elevate the pharmacovigilance profession globally, contributing to the safer use of medicines worldwide.

We welcome your comments on these proposals, to be submitted to administration@isoponline.org before 31st August 2021.

Dr. Jean-Christophe Delumeau
Dr. Jan Petracek
co-chairs of the Scoping Group (On behalf of the ISoP Executive Committee).