Letter From the Editors

By Pooja Shah

Welcome to the final edition of PIPELINE for 2021, the publication of which was delayed slightly. This means the new year has already begun and we hope it’s started well for you.

Before we get on to what 2022 has in store for PIPA, I just wanted to reflect on 2021. With COVID-19 - and the uncertainty it brought along with it - continuing to hang around, 2021 was another year where life felt on hold and isolating for many. However, the rollout of vaccines and gradual easing of restrictions meant that a degree of “normality” started to kick in for many of us, which we hope brought with it some long-awaited positivity. Not only did 2021 see the introduction of new vaccines and therapies for the prevention and treatment of COVID-19, we shouldn’t forget the huge amount of research that is continually ongoing in other areas to provide hope for many living with incurable or life-limiting conditions. For example, in March 2021, the National Institute for Health and Care Excellence (NICE) approved a gene therapy, Zolgensma, for the treatment of severe spinal muscular atrophy in babies. At £1.79m, the drug is reportedly one of the most expensive to ever be granted use by the NHS. The importance and value of pharmacovigilance was also highlighted internationally when reports on the side effects of the COVID-19 vaccines where published. The interest in PV was fuelled further when a review by the MHRA found, from ongoing safety surveillance, that of the 20 million people who had received the Oxford–AstraZeneca vaccine in the UK up to 31 March 2021, 79 people had suffered rare blood clots – 19 of whom died. As a result, the Joint Committee on Vaccination and Immunisation (JCVI) advised that under-30s should be offered an alternative jab to the Oxford–AstraZeneca vaccine due to the evidence linking it to rare blood clots. September saw the rollout of the booster vaccines and, in November, the Omicron variant emerged. In other news, we saw the demise of Prince Philip, an unveiling of a statue of Princess Diana at Kensington Palace by her two sons, and a State of the UK Climate report, published by the Met Office, which concluded that 2020 was the third warmest, fifth wettest and eighth sunniest year on record. According to the authors of the report, this, and the trend since 1990, showed climate change is already happening in the UK. Continuing this theme, the UK hosted the 26th UN Climate Change Conference of the Parties (COP26) in Glasgow on 31 October – 13 November. In sport, England made it to

the final of the UEFA Euro 2020 championship which was watched by 31 million people - making it the most watched programme since Princess Diana’s funeral in 1997. And let’s not forget the 2021 Olympics, where team GB walked away with an amazing 65 medals. Whilst we are on the topic of sport, our ex-PIPA committee member, Tazneem Anwar, has recently been featured in Strava’s campaign and blogs such as ‘Building Community Through Running’. I’m sure many of us went through highs and lows in 2021, but we hope the year also gave you the opportunity for personal growth, for finding balance in all aspects of your life and gave you space to think and prioritise your time and efforts on what is important to you. We hope 2022 gives you time to continue with your personal development. We also hope 2022 provides the opportunity for career development and further training. Our Training Working Party have been working extremely hard over the last year to expand our courses for you and to suit all career paths. This year, we have brought back some of our face-toface trainings as we know there is value in meeting one another and bouncing ideas and thoughts off your peers and colleagues. With that in mind, the annual PIPA conference will once again be a face-to-face event. We look forward to meeting with you all again on 28th – 29th September 2022! Booking for this not-to-be-missed event is now open on the PIPA website, along with details of the conference programme: https://pipaonline.org/ conference/conference-2022/.

PIPA have also developed a continuing professional development (CPD) portal on its website, which allows easing recording and tracking of your professional development, allowing you to move up the levels of PIPA membership as you develop your career in Medical Information and/or Pharmacovigilance. This is a great resource for your own personal development so I cannot encourage you enough to read the article inside on this and start collecting your points. As usual, throughout 2022, we will be continuing with our free PIPA forums and webinars and PIPELINE journals. We have also developed a database of vendors and companies that offer PV and MI services on our website, as well as our existing contractors’ database. These databases list the type of services that the organisations provide, allowing you to easily find a match to your requirements – be it out of hours cover, audit consultancy, medical writing or a software solution etc. If you would like to advertise your company on one of these databases, please contact us via pipa@pipaonline.org for further information.

Please remember, if there is anything you would like to see PIPA get involved with or do, please do get in touch via pipa@pipaonline.org. Going back to this edition of PIPELINE, we are delighted to present a wide range of articles, including summaries of some our conference sessions including one on medical device regulations and another on the relationship between the NHS and Pharma. We also have an article on responding to the MHRA’s requirement for a UK Pharmacovigilance System Master File (PSMF) by Vasavi Kalyani, John Verheul and Amisha Sandhu from Novartis. We also have an article by Dr Keith Tsui from MedWise AI on smart search and modern medical information (MI) – delivering value for your teams and the wider business, as well as an article on implementing conversational articificial intelligence in MI by Shai Blackwell. We’ve listed only a few of the many topical articles that we have collated for this edition, and we hope you enjoy reading it as much as we have enjoyed putting it together. As always, we welcome your feedback and encourage you to interact with us and the other PIPA members via our online platforms. On that note, we hope to ‘see’ you all at some point this year, and we hope you and your loved ones continue to stay safe and happy! Until the next edition of PIPELINE which will be after Easter, we hope you all have a wonderful start to 2022. If you want to make a contribution to PIPELINE, please feel free to contact us at journaleditor@pipaonline.org.

Pooja Shah

PIPELINE Editor