A New President’s Vision for International Pharmacovigilance

I am honoured and delighted to have been elected as President of the International Society of Pharmacovigilance (ISoP), as announced on 28 October 2019 at our Annual General Meeting in Bogota, and am especially proud to be the first woman to ever hold this role in our professional society. I would like to thank all ISoP members who voted for me and other members of our new Executive Committee and Advisory Board. Worldwide, women constitute approximately 70% of the pharmacovigilance workforce; it is therefore both gratifying and appropriate that membership of the ISoP Advisory Board for 2019–2022 (see https://isoponline.org/about-isop/advisory-board-2019-2022/) reflects this distribution.

In this editorial, I will outline my vision for ISoP and pharmacovigilance during the next 3 years, following on from my first presidential address in Bogota. I will also introduce the new members of the ISoP Executive Committee and Advisory Board, explaining their new roles in our society.

We Are All Pharmacovigilantes!

ISoP now includes over 1000 members from 100 countries, and the key elements that unite us are much stronger than any of our individual differences. I live and work in New Zealand, where the indigenous Māori people have a saying “He waka ake noa!”, literally meaning “We are all in this canoe together!”, and, more broadly, encouraging a unity in purpose. This is my philosophy for how we should operate in pharmacovigilance. Whether we come from a clinical or academic background; from medicines regulation or other governmental bodies; from non-governmental organisations (NGOs) or charitable organisations; or from the pharmaceutical industry, within ISoP we must all paddle in the same direction to achieve safer use of medicines worldwide. Our professional society is a place where we can educate, collaborate, network and support each other in conducting the essential tasks of monitoring the safety of pharmaceutical products, whatever our personal or professional backgrounds.

Patient-Centred Pharmacovigilance

We must never forget that patients are at the heart of our work. In my experience as a clinical doctor, having also been employed in academic research, medicines regulation, pharmacoepidemiology (as former Director of the New Zealand Intensive Medicines Monitoring Programme) and working as a writer (see https://www.miraharrison.com/), I have learned that in order to maximise the safe use of medicines/devices, and to conduct appropriate risk management in any environment, including drug development in clinical trials, we must understand how products are used in real life. This includes knowing how drugs are obtained by patients; how they are taken, inserted or applied (or not!), and, in addition to the clinical factors that may affect safety (e.g. personal medical history; concomitant medicines), how societal or cultural environments may affect efficacy or safety in each individual. Including and consulting with patients and helping to better integrate pharmacovigilance with clinical medicine and public health systems should be fundamental parts of the ISoP mission.

Special Interest Groups (SIGs)

International pharmacovigilance has broadened in scope to include study of medication error, medical devices, herbal and traditional medicines, vaccine safety, women’s medicines and risk minimisation methods. This is reflected in our ISoP Special Interest Groups (SIGs) (https://isoponline.org/special-interest-groups/), which I encourage all ISoP members to join and participate in, depending on your area of interest. There are plans to develop common themes across all the ISoP SIGs (for example, patient involvement in pharmacovigilance, risk communication practices), with presentation of this work at future ISoP conferences. Our leadership team also has ideas for new SIGs, for example on biologicals and advanced medicines, and would like to include more pharmacoepidemiology into ISoP courses and conferences. We will reach out to colleagues worldwide to assist and collaborate with us.

The New International Society of Pharmacovigilance (ISoP) Leadership Team for 2019–2022

The new ISoP Executive Committee and Advisory Board include pharmacovigilance experts from a wide range of countries, backgrounds and workplaces (https://isoponline.org/about-isop/advisory-board-2019-2022/), as summarised in Table 1. All have been democratically elected by ISoP members worldwide and conduct their work for ISoP as volunteers. I would like to acknowledge their generosity in donating so much time to our society; the enthusiasm and support that every Executive Committee/Advisory Board member provides to our leadership team is inspiring! I am extremely lucky to have such a hard working and diligent team behind me.

Table 1 ISoP Executive Committee and Advisory Board members 2019–2022

Additional Leadership Roles and Communication

During our first Board meeting in Bogota in October 2019, the following Executive Committee/Advisory Board members agreed to undertake other leadership roles for ISoP:

Chapters Co-ordinator: Rebecca Chandler

CIOMS representatives: Manal Younus and Sten Olsson

Communications Team: Deirdre McCarthy, Angela Caro and Mónica Tarapués

Fellowship Nominations Sub-Committee: Deirdre McCarthy (Chair)

ISPE and EnCePP liaison: Gianluca Trifirò

SIGs Co-ordinator: Angela Caro Rojas

UMC/WHO liaison: Rebecca Chandler.

The Communications Team has already started work on updating the ISoP website (https://isoponline.org/), so please keep an eye out for upcoming events. News will also be regularly shared via the ISoP Twitter handle @ISoPonline—we now have over 1500 followers, so do join us!

ISoP Global Areas and Regional Leaders

ISoP is a truly global society, growing each year in number and diversity of members. We welcome everyone with an interest in the science and practice of pharmacovigilance, and seek to serve our membership to the best of our ability. Please encourage your colleagues to join us and submit their membership application at https://isoponline.org/members/.

ISoP has several regional chapters in the eight areas of the world, some chapters including more than one country, for example the Latin American and Western Pacific chapter (for more details, see https://isoponline.org/chapters/). In order to better represent ISoP members, I have appointed two Regional Leaders for each of these areas, as shown in Table 2.

Table 2 ISoP regional leaders

All ISoP members are encouraged to contact the Regional Leaders for their area, informing them of how our society can serve your needs. We want to hear from you about the type of training and support you want, your ideas for ISoP Chapters or SIGs, or your concerns about pharmacovigilance issues in your country. Please email the ISoP Secretariat at administration@isoponline.org and we will put you in touch with the best person to help.

Every year, ISoP holds chapter, regional and international meetings, and training courses around the world. I encourage you to attend any that may be of interest and benefit to you (for more details, please refer to https://isoponline.org/). In 2020, our mid-year meeting and training course will be in Moscow (https://isoponline.org/training/midyear-training-moscow-april-2019/) and the annual ISoP conference will take place in October in Oman (http://www.isop2020oman.org/). Both of these meetings offer exciting opportunities for pharmacovigilance education and networking—I look forward to meeting you there.

Welcome to ISoP and Thank You!

Finally, I would like to warmly welcome all new ISoP members who have joined since our recent successful meetings in Bogota (October 2019), Guangzhou (November 2019) and Boston (December 2019). You may have already made new friends and colleagues at these meetings and I encourage you to stay in touch, making the most of your membership in the ways I have outlined in this editorial. For those of you who have been ISoP members for a long time (a significant and growing number of us now), please accept my personal thanks for your commitment and enthusiasm for pharmacovigilance worldwide and I look forward to working with you in my new role.

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Correspondence to Mira Harrison-Woolrych.

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All ISoP Executive Committee and Advisory Board roles, including the President’s role, are unpaid, although my travel to ISoP 2019 in Bogota was paid by ISoP. No funding or payment has been received for the preparation of this editorial.

Conflict of interest

Mira Harrison-Woolrych has no conflicts of interest in relation to this article.

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Harrison-Woolrych, M. A New President’s Vision for International Pharmacovigilance. Drug Saf 43, 79–81 (2020). https://doi.org/10.1007/s40264-019-00902-6

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