President’s message 
This year has been demanding, both professionally and personally, for many ISoP members, but I am proud of how our society has risen to the ongoing challenges of performing our pharmacovigilance work during the ever-changing environment of the COVID-19 pandemic.  Although most of us have not been able to meet in person, this has been one of the busiest and most productive years ISoP has ever known. A glance through the pages of this edition of the ISoP Star will illustrate just some of the many activities which ISoP members have been part of this year. 
In addition to our mid-year Eurasian meeting in June and the ISoP 2021 annual conference organised by our Middle East colleagues in November, there have been a number of regional and specialist webinars organised by ISoP members around the world. We have seen increased activity in ISoP chapters and Special Interest Groups (SIGs) and this is a credit to the hard-working chapter and SIG heads who donate so much of their time and energy to ISoP.  New chapters and SIGs are currently being formed and will get under way in 2022. This is an exciting time for ISoP, as we extend across more regions of the world. I am delighted there has been a significant increase in ISoP membership this year and we warmly welcome all new members into our society. Please become engaged with the activities offered to ISoP members and you are sure to enjoy meeting fellow pharmacovigilantes from across the globe!
Leadership of ISoP continues to be a privilege I take seriously. At the end of my second year, in addition to being the first female president of our society, I may now claim to be the first pandemic president. The COVID-19 outbreak has presented many unexpected challenges, but ISoP has responded with determination and creativity and we have emerged a stronger and more successful organisation. I believe that diversity and dedication in the ISoP leadership team has contributed to our success: I would like to thank my Executive Committee colleagues, Rebecca Chandler (Vice-President) Jean-Christophe Delumeau (Treasurer) and Deirdre McCarthy (Secretary General) and all Advisory Board members for their exceptional work and unfailing support.  
It was wonderful to read comments posted by ISoP members at the end of our General Assembly in November, saying ISoP is an example of a truly global professional society, in which we are inclusive, supportive and respectful of each other. I couldn’t agree more. We have missed seeing each other in person this year, but we have remained in touch in other ways and I know this will continue into 2022 and beyond.
I wish you and your families, friends and loved ones all the very best for the holiday season and the new year ahead. 
Dr Mira Harrison-Woolrych
ISoP President    

 Annual meetings are back!
With 300 participants, including 75 delegates present in the Grand Millennium Hotel in Muscat, ISoP annual meetings came back on track after the enforced break since we met in Colombia in 2019. Hosted by the Oman Ministry of Health, the ISoP 2021 annual meeting took place on 8-10 November online and with on-site activities in Muscat for those able to attend in person. 


 
There were 35 speakers from 20 countries across five continents, 15 packed sessions each of 90 minutes, including 11 oral presentations selected from submitted abstracts; in all 108 accepted abstracts are to be published in Drug Safety. Special Interest Groups and Chapters had their moment too, with dedicated sessions. 
 
There were three keynote presentations, from Rachida Soulaymani-Bencheikh, Morocco (the Beje Wiholm lecture, titled ‘A unified national approach for safety surveillance of all medicinal products’), Lembit Rägo, Switzerland (CIOMS lecture on patient involvement), and Patrizia Cavazzoni, USA (‘Integrated pharmacovigilance for safer patients’).
Three satellite training courses were scheduled separately from the main programme on the ISoP Zoom platform: ‘Pharmacoepidemiological methods in pharmacovigilance’; ‘Managing safety signals in daily practice’ and ‘Making and Assessing Periodic Benefit-Risk Evaluation Reports’.
 
From the posters displayed, the 1st prize was awarded to Leàn Rolfes et al for ‘Cohort Event Monitoring of COVID-19 vaccine – reactogenicity in the Netherlands using patient reported outcomes’ (P026), 2nd prize to L. Grimaldi et al for ‘Acute Relapse Following Vaccination in Multiple Sclerosis Patients: A Nationwide Epidemiologic Study using the French Healthcare Databases’ (P077), and 3rd prize to N. Al-Fadel et al ‘Implementation of Risk Minimization Measures to Reduce the Risk of Tuberculosis among Anti-Tumor Necrosis Factors Users’ (P001). The winners received a one-year subscription to a journal of their choice (kindly donated by Adis Premier journals) and an ISoP free membership.


 
Thanks and congratulations to Mayada Alkhakany, Thamir Alshammary of the Middle East Chapter, all the Local Organising Committee and to Sten Olsson and the Scientific Committee. This year more than ever it was important to keep our ISoP community together and to share the latest developments in pharmacovigilance – an achievement fulfilled.
 
 An Assembly for All
The ISoP General Assembly (GA) took place over Zoom during the ISoP Annual Meeting on 9 November. Chaired by President Mira Harrison-Woolrych and Secretary-General Deirdre McCarthy, with participation of the ISoP Executive Committee (EC) and Advisory Board (AB) members, the GA provided many significant updates relevant for the society. Over the last 18 months the ISoP EC and AB have been undertaking measures to minimize ISoP’s financial risk during the COVID-19 pandemic. The introduction of lower membership fees for low- and middle-income countries has resulted in an increase in membership applications. Treasurer Jean-Christophe Delumeau reported that the society’s assets remain healthy. 
 
 Scoping Group
During this year, a Scoping Group (chaired by Jan Petracek and Jean-Christophe Delumeau with ISoP Advisory Board members Manal Younus, Mónica Tarapués and Li Zhang) has been examining possible future directions for ISoP and have submitted a detailed report to the ISoP (EC) for consideration. This recommended a new Scientific Board, and a Global Pharmacovigilance Professional Certification (GPPC) programme. 
At the General Assembly President Mira Harrison-Woolrych spoke about the report and recommendations, which had been sent to all ISoP members for consultation. The vast majority of responses were positive and supportive of forming the ISoP Scientific Board and of piloting of a GPPC. 
Senior ISoP members were invited to submit an application to join the new Scientific Board, which will be appointed in early 2022. A Global Pharmacovigilance Professional Certification (GPPC) will be piloted in collaboration with the Indonesia Chapter in early 2022; suggestions for curriculum questions will be included, along with fees and links to ISoP membership. The global roll out of GPPC is planned for later in 2022.
 
 Membership
Following the Oman annual meeting membership stands at over 800, with 292 new members in 2021, compared to 103 new members in 2020. Of these 292, 100 are from high-income countries, and 192 from lower- and middle-income countries. Currently 44% of ISoP members are from Europe, 13% from South America, 11% North America, 11% from Africa, 8% from both Western Pacific and Asia, and 7% from the Middle East.
 
 2021 Fellows
We are delighted to announce that the following ISoP members received fellowships at the 2021 General Assembly:
⋆ Dr Thamir Alshammary, Saudi Arabia
⋆ Dr Ian Boyd, Australia
⋆ Ms Angela Caro, Colombia
⋆ Dr Rebecca Chandler, Sweden
⋆ Dr Ulrich Hagemann, Germany
⋆ Dr Marie Lindquist, Sweden
⋆ Dr Manal Younus, Iraq
 Many congratulations to all our new ISoP Fellows!
 
  New Honorary member
Dr Luisa Valdivieso was awarded an Honorary Membership at the 2021 General Assembly. She has had a long and distinguished career and was the Director of the Pharmacovigilance programme of the Ministry of Health in Venezuela. The ISoP EC thanked Luisa for all she has contributed to international pharmacovigilance.
 
 World Patient Safety Day
The World Patient Safety Day in September was again marked by ISoP with six well-attended online educational sessions coordinated by Angela Caro and organized in collaboration with the ISoP Medication Error Special Interest Group (SIG). ISoP hosted 6 sessions over two days (16 and 17 September) with 12 speakers and 9 hours of transmission. Over 1,000 people on social media showed interest, with more than 600 real-time attendees. 
 
All the recordings from this year’s Patient Safety Day are available on the ISoP YouTube channel at
 https://www.youtube.com/channel/UCo-jtROXZbiDk_1GLxzThzQ/playlists

The next World Patient Safety Day will be 17 September 2022.
 
 Boston 2021
The 5th ISoP Boston Seminar took place virtually on 6 and 7 December 2021. 'Intelligent Automation in Pharmacovigilance' was a highly focused, scientific and interactive two-day virtual event. 
International experts across the pharma and technology services were invited to contribute and debate this hot topic online. Speakers came from academia (USA, France), health agencies (USA, UK, EMA) and the pharmaceutical industry. Many thanks to Jan Petracek (ISoP Advisory Board member) who coordinated the seminar. 
The proceedings of the seminar will be published in the upcoming Drug Safety themed issue on the Role of Artificial Intelligence/Machine Learning in Pharmacovigilance, to be guest edited by Andrew Bate and Yuan Luo.
The dates for next year’s seminar are already confirmed – 5 & 6 December 2022 – so please make a note in your diary and we look forward to seeing you there!
 
 Special Interest Groups (SIGs)
Risk Communications
Virtual CommSIG meetings were held in June and September 2021 to discuss publications from CommSIG meetings on the nocebo effect and the infodemic, as well as to form plans for 2022.

Herbal and Traditional Medicines (H&TM)
Two topics have been proposed for the next projects for the H&TM SIG: COVID-19 and herbal and traditional medicines; and coding and classification challenges and solutions for H&TMs.
The final manuscript for a new book on pharmacovigilance for herbal and traditional medicines has been submitted, with H&TM SIG lead (Jo Barnes) as editor/author and several H&TM SIG members authoring/co-authoring chapters. The book should be published in 2022 by Springer.

Women's Medicines
The SIG secretary, Ulrich Hagemann, regularly circulated research papers regarding women's medicines to SIG members, including COVID-19 in pregnancy, and vaccination of pregnant women. In September the SIG presented to the UK Consortium on Pregnancy and Breastfeeding, and in November hosted a successful session at ISoP 2021.

Vaccines
During the course of 2021 around 16 members met every four to six weeks. The COVID-19 vaccines infographic was developed, plus work with ISoP LATAM and Israel on the vaccines webinar series and an upcoming contribution to NaSoP annual meeting.

Medication Errors
The Medication Safety Officer and Safe Prescription projects continued during the year. The MedDRA coding group will be giving feedback on COVID related terms to EMA.

Pharmacogenomics
The SIG meets regularly by Zoom, working on a promotional video and other communication strategies.
 
PV Professional Qualification Framework
The SIG, which first developed the Global Pharmacovigilance Professional Certification (GPPC), was busy this year preparing the proposal for the Scoping Group and the Pharmacovigilance Career Framework Guideline.

Medical Devices
The Medical Devices SIG was relaunched during 2021, with Omar Aimer (Canada) as lead.

Patient Engagement
This new SIG was launched during the General Assembly by co-ordinators Mayada Alkhakany (Germany) and Manal Younus (Iraq). The aims of the SIG are to empower the patient to be an integral part of the safe use of medicines, and to
⋆ create an ISoP Patient Engagement Group to shape the future of the patient’s involvement in pharmacovigilance
⋆ create a patient advocacy representative in each chapter to work closely with patient organizations and act as a coordinator of the patient to support the vision of the ISoP PatEG
⋆ develop a strategy to support the voice of the patient to improve safety, disease management, and treatment adherence
⋆ support the patient to be one of the key players in the decision-making in the drug development and treatment plan.
This was a busy year for all the ISoP SIGs. Details on how to join a SIG may be found on our website – do go and have a look!


 
 Chapters keep growing
ISoP members in one country or geographical region are able to form groups (Chapters) to facilitate the organisation of meetings, training courses, or other activities related to the mission of ISoP.
The status of ISoP Chapters (with year of founding) as of October, is:

⋆ Italy (2006)                                                                  18 members
⋆ Western Pacific region (2007)                                   62 members
⋆ Switzerland (2009)                                                     21 members
⋆ LATAM (2009, merged with Mexico in 2021)           94 members
⋆ Africa (2010)                                                                80 members
⋆ South-Eastern Europe (2012)                                    13 members
⋆ North America/NASoP (2013)                                    86 members
⋆ Israel (2014)                                                                    3 members
⋆ Middle East (2015)                                                       36 members
⋆ China (2016)                                                                 15 members
⋆ Indonesia (2017)                                                           11 members
⋆ Egypt (2020)                                                                 17 members
 
A report from the Chapters reveal that they have been incredibly busy during the last year.   
The ISoP Middle East Chapter served as host for our successful first hybrid ISoP Annual Meeting in Oman in November!  An incredible effort by chapter members to which we are all incredibly thankful.  Another highlight was the very informative webinar on the safety of covid-19 vaccines with Madhav Balakrishnan from the WHO earlier in the year.
ISoP Israel has very pro-actively addressed issues related to the COVID-19 vaccines given the early covid-19 vaccination campaign in that country.  It joined with ISoP LATAM and the Vaccine SIG to coordinate the ISoP Vaccine webinar series last spring, and it aligned its mission to meet the challenges of the "infodemic" with efforts focused to be a source of evidence-based information, to educate the general public and health care professionals and to counter "fake news" about COVID-19 vaccines.
The ISoP Western Pacific chapter organised a virtual webinar on World Patient Safety Day that was attended by many members and non-members. The session comprised two speakers: Professor Libby Roughead spoke on Digital biomarkers and whether they can improve opportunities for improving pharmacovigilance, and Professor Ian Wong gave a presentation on findings from his work with the COVID-19 vaccines adverse events response and evaluation (CARE) programme. 
ISoP China contributed a session entitled “Pharmacovigilance and Drug Risk Management” in collaboration with Clinical Toxicology Committee of Chinese Society of Toxicology at The Forbidden City International Pharmacist Conference in September.  Also, the chapter successfully delivered a session entitled “Monitoring the safety of medicines in Special Populations” in partnership with the CDR NMPA 21 Oct 2021 during the 8th Pharmacovigilance Conference in Nanjing, China.
ISoP Africa hosted a 3-day conference in August entitled "Setting the stage for pharmacovigilance inspections in Africa".  Speakers included many of the members of the Chapter EC as well as fellow ISoP members from the Middle East and Egypt Chapters.
ISoP Egypt had achievements in a number of different areas including education, research and communication.  A few examples of education initiatives Medication Errors training in January and multiple COVID-19 related webinars.  
There was also a research project by EU2P student Samaa Bayoumi “Effect of proper pharmacovigilance awareness on community pharmacist’s knowledge, perception and impact on practice in Egypt.  Establishment of social media channels and promotion of Patient Safety Day round out a year full of activities.
Elections were held in February for the first EC of the newly merged chapter from the former separate LATAM and Mexico chapters.  A great delight to see the results reflecting a wide geographic range within the region. After several months of engagement and feedback with members, the Latin America chapter held its first Annual Meeting in late November.
For NASoP, a very exciting development is, in collaboration with the successful Eu2P programme, the launch of Am2P, offering pharmacovigilance courses targeting North America medicines-stakeholders, offering both certificate and short course options.  They have recently held their annual meeting in December.  They also published an “An update from the North American Chapter of the International Society of Pharmacovigilance” in Drug Safety.
ISoP Italy hosted two webinars in the fall.  2022 will be a busy year for this chapter as they will host the next Annual Meeting in Verona in September.
ISoP Indonesia has been very active in partnerships with other stakeholders in Indonesia.  They contributed to a National Dialogue: Uniting Multisectoral Effort in Pharmacovigilance to Improve Public Health Protection” and Patient Safety Day events in the country.  
They also co-hosted a webinar with the Indonesian Food and Drug Authority "Pharmacovigilance in The Product Lifecycle and The Central Role of National Regulatory Authority”.
With great excitement, the new South Asian Chapter “SASOP” was introduced at the Annual Meeting. Led by Moin Don and Krishna Undela, the Chapter will include members from India, Sri Lanka, Bangladesh, Bhutan and Nepal.
 
 New Chapters Co-ordinator
 Mónica Tarapués, ISoP Board member, will be the new ISoP Chapters coordinator in 2022. ISoP would like to thank Rebecca Chandler for coordinating Chapters activities in 2021.
 
 Chapters in print
 Partnerships between the ISoP Egypt Chapter and other organisations resulted in multidisciplinary collaborations which allow using the tools and resources to assess and manage adverse drug reactions jointly. More details can be found in the manuscript in Drug Safety “A Multidisciplinary Approach in Pharmacovigilance Awareness: ISoP Egypt Chapter’s MedSafetyWeek Experience”.
 
 Pharmacovigilance Journal Club
In collaboration with Drug Safety, ISoP’s official journal, our fourth webinar was held on 29 September. 
A recent publication in Drug Safety entitled “A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews”, co-authored by Su Golder, Senior Research Fellow, Department of Health Sciences, University of York (UK) was presented. It was well attended and very engaging!
 
The Journal Club is a series of free webinars for ISoP members only, who can watch the recordings of the previous webinars on the Members section of our website.
The next edition will be scheduled early February 2022. We will let you know the date, so please join us then!
 
 Meetings in 2022
 Southampton 2022
The ISoP Mid-Year Meeting 'Beyond spontaneous reporting: integrating data from multiple sources to ensure medicines safety' will take place online in May 2022, in Southampton, UK.
  
 Benvenuti a Verona!
The ISoP Annual Conference next year ‘A new era of pharmacovigilance: challenges and opportunities’ will be held in the beautiful and ancient city of Verona, Italy from 20-23 September
Gianluca Trifirò is the head of the Local Organising Committee and Angela Caro chairs the Scientific Committee. Angela and Gianluca and other members of the Scientific Committee will be developing an exciting international scientific programme, which may include topics such as:
 
⋆ Artificial intelligence in pharmacovigilance
⋆ Safety monitoring of digital therapeutics
⋆ Database networks for post-marketing surveillance for vaccines and medicines
⋆ Patient-oriented pharmacovigilance
⋆ Risk communication during emergencies
⋆ Pharmacovigilance of advanced therapy medicinal products
⋆ Ecopharmacovigilance
⋆ Lessons learned from COVID-19
 
Members of the ISoP Italy Chapter will assist in the local preparations.
 
This short video provides an introduction to the meeting: https://www.youtube.com/watch?v=lVoimKBJDlU 
We look forward to seeing you in Verona!
  
 In Memoriam ~ Michel Ollagnier
We learned with much sadness of the death of Professor Michel Ollagnier on 21 March 2021. 
He was a Professor of Clinical Pharmacology, and Director of the Regional Pharmacovigilance Centre of Saint-Etienne, France, and was the last Vice-President of the European Society of Pharmacovigilance (ESOP). He played an important role at the time of the founding of the International Society of Pharmacovigilance. 
The Société Française de Pharmacologie et de Thérapeutique called Professor Ollagnier “a true musketeer of pharmacovigilance” (“un vrai mousquetaire de la pharmacovigilance”). His cheerful and committed presence at ESOP and ISoP annual meetings will be remembered with affection by many. 
 
 Come forward for the Board!
Would you have the time to commit to undertaking the role of a member of the ISoP Board? Would you like an opportunity to contribute and help ISoP to be a robust, professional and leading society in pharmacovigilance? …then we are interested in hearing from you! There will be elections to the Board in 2022.
Paid-up members with appropriate skills and experience who would like to put themselves forward as a candidate are invited to contact the Nominating Committee.
Please contact Sophie Spence as soon as possible via: [email protected] with any queries.
 
 Membership renewals 
For the latest fees and information please refer to the ISoP website:
https://isoponline.org/members/how-to-join-fees/

We look forward to your renewals and involvement in the Society in 2022.
 
 Stay in the loop
 All ISoP's social media channels continued to grow during 2021 with increased followers across the board – so why not join us on Facebook, Twitter, Instagram or LinkedIn?
 
The website https://isoponline.org/  is updated regularly, and the Members-Only section is where you will find access to the journal Drug Safety, presentations from the annual meetings, and have the chance to update your personal information.
 
As always, please send your letters, comments, ideas and contributions for ISoP Star to:
 
ISOP SECRETARIAT LTD
140 Emmanuel Road, London SW12 OHS, UK
⋆ Telephone and fax: +44 (0)20 3256 0027
⋆ E-mail: [email protected]
⋆ Internet: www.isoponline.org