Starting and running a special interest group

A special interest group in a medical writing association begins when members show they want one and propose it to the association's governing committee. It takes its shape from what its founders say it is for, from its launch and from its first months. It is kept going by a small committee, a pool of volunteers and a programme built with other groups and with the regulators, and the volunteer time behind it bounds what it can keep up.

Members' demand for a group

The idea for EMWA's pharmacovigilance special interest group was born at a discussion panel at the association's spring symposium on risk-benefit evaluation, in Dublin in May 2015, where the audience was asked with voting pads whether they were interested in pharmacovigilance writing, whether they were involved in it and what they thought about various pharmacovigilance topics. ^{1, 2, 3} The session was so well attended that the panel thought there should perhaps be a subsection on the new topic of pharmacovigilance medical writing. ³ To the group's first chair, who sat on that panel, the group answered a clear need from EMWA's members, and she would like to think that this is what EMWA does best. ^{3, 4} The group's own account adds that EMWA had become aware of pharmacovigilance as an area for writing because its documents are complex and it is valuable to have professional writers write them or coordinate their preparation, and that EMWA had been trying to strengthen the area and to offer its members training options and updates on pharmacovigilance. ⁵

At the start, the group's members asked each other whether anybody was out there, how big the interest was and how big EMWA's community of pharmacovigilance writers was, since pharmacovigilance is a niche within medical writing. ⁶ The interest showed in emails from members wanting to contribute to the group or to receive more pharmacovigilance offerings from EMWA. ⁶ It also showed in registrations for the group's expert seminar session at the May 2018 Barcelona conference, which stood at over 30 in March, a figure the group's chair assumed had since grown. ^{6, 7, 8} At the group's first content webinar, in September 2019, its presenter took the many attendees as showing great interest in pharmacovigilance writing. ⁹

In 2024 the translation enthusiasts subgroup, which its hosts described as a fairly new but rapidly growing part of EMWA's medical communications special interest group, presented what they called the first ever seminar on translation. ¹⁰ Its hosts took the number of people who had signed up for the seminar as telling of how important the subject is, and 42 people were present when they polled the audience. ¹¹

What a group is for

EMWA's special interest groups are focus groups of members with a common interest who want to meet, discuss and share information and best practices in their areas. ¹² The groups let the association and its members contribute to important conversations around topics that will affect the industry, or medical writing, in the coming years. ^{13, 14, 15, 16}

In March 2016 EMWA's president called the groups the association's own talking shops on hot topics that are expected to develop and endure. ¹⁷ The pharmacovigilance group would delve into issues affecting the pharmacovigilance documents members write, and with regulators directly involved, members could ask the questions that mattered to them. ¹⁷ The regulatory public disclosure group was to be launched as EMWA and AMWA published the open-access CORE Reference in May 2016, as a natural follow-up to it. ^{17, 13} It would focus on public disclosure of clinical regulatory documents, on the expectation that disclosure would affect their content and structure, increase their range and create the need for new documents, which the medical writer would support. ^{13, 18}

In March 2017 the reasons given for the pharmacovigilance group were the growing interest among medical writers in safety writing and the understanding that safety writing and medical writing differ in subtle ways. ¹⁸ The group aimed to bring EMWA members together to discuss and share information and best practice in pharmacovigilance and pharmacovigilance writing, and to increase dialogue within the medical writing community and between it and the regulatory authorities. ¹⁸ It would hold an annual pharmacovigilance update session during the spring meeting, to discuss current pharmacovigilance topics from different perspectives and to encourage dialogue with the regulatory authorities. ¹⁸ It would act as a resource for medical writers interested in pharmacovigilance by posting guidance and updates to guidance as appropriate, and would liaise with EMWA's professional development committee to advise on additional training for members in pharmacovigilance writing and pharmacovigilance. ¹⁸

As its first chair later put it, the pharmacovigilance group's main aim was to bring EMWA members together and start a dialogue in which EMWA writers' considerable experience of pharmacovigilance would be shared, in a forum that would hopefully move towards an informal best practice. ^{19, 4} Beyond that, the group set out to increase dialogue both within the community and between the medical writing community and the regulatory authorities, an aim she feels very strongly about. ¹⁹ The group also wanted to act as a resource for anybody interested in the area, whether already working in it or entirely new. ²⁰

In March 2023 EMWA's entrepreneurship group set out to support members looking to expand their business. ²¹ It aimed to create a network of members who have taken the next step from working solo to running a company, whatever the business model, and a professional space where members can access business advice and learn from the experiences of others at varying stages of their business development. ²¹

By June 2025 EMWA's special interest groups had grown from one, on pharmacovigilance, established in 2015, to nine active groups, of which the newest was on visual communications. ²² The association then described them as focus groups that bring together members who share common interests and collaborate on topics shaping the future of medical writing. ²² All the groups and their volunteers contributed to EMWA through journal articles, webinars, workshops, seminars and conference sessions. ²²

The proposal to the governing committee

In 2023 every EMWA special interest group was open to all members, and any member could propose and start a new one. ¹⁶ A proposal to start a group should be sent through EMWA's head office to the executive committee for review and approval, and the association asked those setting up a group to follow its published recommendations for doing so. ^{16, 12}

The pharmacovigilance group's first chair took the idea to the executive committee and discussed it with the two members who had organised and chaired the 2015 symposium, both of whom were willing to be involved. ^{23, 2, 3, 4} Together they drew up their own rules and regulations, decided on the group's aims and proposed them to the executive committee, which endorsed the group. ²³ Two further members helped them form the first committee and produce the rules, regulations and aims. ²³ The executive committee did not take long to approve the idea, and the group was up and running before the November 2015 conference in The Hague, where it was launched. ^{24, 25} Its aims have since been expanded but have not changed beyond those first put to the executive committee. ²³

A group's launch

The regulatory public disclosure group launched at EMWA's spring conference in 2016 with an introductory session on 12 May, alongside the launch of the CORE Reference. ²⁶ The session was very well attended and enthusiastically received. ²⁶ The session opened with the background to the regulatory public disclosure environment of the time and why it is important to medical writers, the group's objective of providing a forum for the discussion and sharing of information, best practices and ideas with EMWA members, and the names of the proposed advisory panel who would support the group by freely sharing their knowledge and expertise. ^{26, 18} The group's new website was then presented, with resources that included a glossary of terms, a library of key references and background reading, and a question-and-answer log. ²⁶ The presentation closed on the next steps and a request that volunteers share ideas and experience, which would be a key component of the group. ²⁶ The session ended with questions from the audience, and many of the conversations continued into the refreshment area. ²⁶ The group's first formal session was to be part of the symposium day at the 2017 spring conference. ²⁶

The pharmacovigilance group held its first session at the same 2016 spring conference, in Munich, under the title "Are we ready for the patient's voice through social media in the benefit-risk assessment of drugs?", and although it was held late on a Friday afternoon it was very well attended. ^{27, 25} Besides an account of the group's work, the session had presentations from the MHRA on its WebRADR initiative and on big data, and from a pharmaceutical company's head of strategic data analysis and global pharmacovigilance on data from patient support programmes. ^{25, 27}

A group's first months

EMWA's medical device special interest group was founded in November 2017 in Cascais, with two chairs, three committee members and three supporting members. ²⁸ Its objectives were:

• to provide a forum for EMWA members to discuss and share information in the area of medical devices and in vitro devices
• to ensure focus is given to this rapidly evolving medical communication speciality
• to support the implementation of the new EU Medical Device Regulation (MDR 2017/745) and In Vitro Device Regulation (IVDR 2017/746)
• to act as a resource and support group for medical communicators interested in getting into this field
• to increase the educational offerings of EMWA relevant to this field

^{28, 29}

In March 2018 its current and upcoming activities were:

• the EMWA symposium "Medical Devices and Technologies – Emerging Opportunities for Medical Communicators" on 3 May 2018, at the spring conference in Barcelona, flanked by two medical device workshops
• medical devices added as an area of expertise covered by for-credit workshops under EMWA's professional development programme, with more workshops to be offered at future conferences
• a webinar on medical devices by one of the chairs in 2018
• a standard clinical evaluation report template, whose development two committee members were spearheading
• a regular medical device section established in Medical Writing
• topics on medical devices included in the expert seminar series from 2019

^{29, 30, 31}

EMWA was also preparing a medical device track or certificate. ³¹

In September 2019 a new workshop on medical devices was planned for the Malmö conference that November, to complement the device group's work. ³²

Two new groups were created at EMWA's spring conference in Vienna in May 2019, one on veterinary medical writing and one on medical communications. ^{15, 33} By June 2019 the pharmacovigilance, regulatory public disclosure and medical device groups each had their own tab on the EMWA home page. ¹⁵

The veterinary group had two co-chairs, and its committee members and other volunteers, veterinarians by education, founded it to support the visibility of veterinary medical writing. ^{15, 34} One writer had the idea of forming the group after learning of a webinar on veterinary medical writing, but somebody else had had it first: the webinar's presenter had gathered people interested in workshops, and EMWA's then president had the idea to form the group and was instrumental in bringing it together. ^{35, 34} Its first meeting was held in Vienna in May 2019. ³⁴

In 2021, led by two co-chairs, the veterinary group aimed to raise awareness of medical writing in the veterinary community, to show how broad and diverse veterinary medical writing and veterinary communication are, and to encourage more vets to get in touch with medical writing in the veterinary field and to exchange their experiences. ^{36, 37} That year it was holding quarterly online meetings on the last Friday of January, April, July and October, at 3 pm Central European time, open to non-members in 2021 and to be open only to EMWA members from 2022. ^{37, 38}

The medical communications group set out to support EMWA members' publication activities by acting as a source of affordable and updated information. ^{33, 39} The topics it had identified by June 2019 were predatory journals and conferences, medical journalism, writing for patients and lay audiences, and big data disclosure. ³³ It was to be co-chaired by two members, with three committee members and nine members who had confirmed their willingness to act as supporting members. ³³ Articles and EMWA presentations on different topics were to appear in a section of the EMWA website soon to be created for the group. ³³ As EMWA is an organisation of members for members, the group meant to build its programme on the unmet needs of members working in medical and scientific communication. ³³ It invited members to suggest topics and to support it with their know-how and expertise. ³³

The group's first activity, set out in June 2019, was to finalise the AMWA-EMWA-ISMPP joint position statement on predatory publishing and to give it higher visibility. ³³ The activities planned to maximise its impact included a seminar, a webinar, related articles in Medical Writing, further educational materials and liaison with AMWA and ISMPP to maximise educational activities within those associations. ³³ By September 2019 the group's members had taken part in the development and review of the statement and had supported its wide dissemination. ³⁹ A committee member liaised with the publisher of Current Medical Research & Opinion, where the statement was first published, to bring it to all librarians subscribing to the journal and to spread it through the publisher's social media platforms. ³⁹ Other members of the group shared it through their private contacts, and other EMWA members were encouraged to do the same. ³⁹ The group considered sharing the statement with academia crucial and was looking for the best way to do so, and it welcomed suggestions from EMWA members. ³⁹ The statement was to be presented at a lunchtime symposium at the Malmö conference in November 2019, and information on its impact, and possibly its evolution, was to be shared at the Prague conference in May 2020. ³⁹

In October 2020 EMWA's newly founded sustainability special interest group, started by three members, one of them then the association's vice-president, had five committee members and eleven supporting members. ^{40, 41} Its founders held that EMWA needed a forum for medical writers and communicators to discuss and share information on sustainability. ^{41, 42} They also saw the need to raise awareness of sustainability among their peers and wanted to update medical writers on what the healthcare industry does about sustainability. ^{43, 44} The group called for contributions from members, then met to discuss what it wanted to find out. ⁴² It created five work groups: on whether EMWA could be a partner organisation of the United Nations on sustainability, on how EMWA could work on its ecological footprint, on how the pharmaceutical industry deals with sustainability, on a resource centre giving all medical writers proper information on the subject, and on how medical writing is done in the context of the Sustainable Development Goals. ^{45, 46}

The work group on a United Nations partnership had identified that EMWA fits very well into goal 3, good health and well-being, and goal 5, gender equality, and wanted to investigate whether it fits goal 9, industry, innovation and infrastructure, and goal 12, responsible consumption and production. ^{47, 48} All the work groups were then at the stage of investigating whether to commit to pursuing their topics further. ⁴⁸ The work group on whether EMWA could be a carbon-neutral organisation attracted a lot of attention among the volunteers. ⁴⁸ It had two pillars, and for one of them, the carbon footprint of EMWA as a not-for-profit organisation, the group was about to send the executive committee a proposal to collaborate with Lucerne University on investigating it. ^{48, 49}

EMWA's entrepreneurship group met on 1 December 2022 to discuss its agenda and agreed to meet on the last Wednesday of each quarter in 2023, from 1 to 2 pm UK time. ²¹

The committee, its succession and its volunteers

The pharmacovigilance group's first chair stood down after three years, holding that every committee has to evolve and needs fresh leadership, fresh ideas and fresh blood, and she stayed on as a committee member to support the group. ^{50, 51, 4} Her successor had been an active member of the group in the first two years of its life. ^{51, 52} When the new chair took over, two committee members left because of other commitments, and the group felt the need to expand the committee again to bring in fresh ideas, new networks and new people. ^{51, 53}

The group's call for volunteers in 2017 drew applications from people interested in joining the committee and from people interested in the group who might not have the resources to commit as core members but were willing to help as needed. ⁵³ After the May 2017 conference two new members joined the committee, bringing it to five, and the group welcomed its members' differing backgrounds, which led to fruitful discussions and brainstorming. ^{53, 54} From those willing to help in other ways it created a pool of supporting volunteers, which stood at four members. ^{54, 55} Further emails showed growing interest in the group's activities, but the pool stayed at four. ⁵⁵

The group's committee met face to face at every spring conference to discuss what was going on in the group, new ideas and any input from members or anybody else, to brainstorm and to talk about synergies. ⁵⁶ New EMWA members bring different experiences and work backgrounds, and the group tried to use them as much as it could to share that experience across EMWA, which its first chair calls one of the group's real roles. ^{56, 4} The group later decided to extend the face-to-face meeting at the spring conferences to its supporting volunteers, so that they could meet each other, brainstorm and share experience. ^{55, 57} The rest of its brainstorming and discussion took place by teleconference within the committee. ⁵⁷

Sharing out the work, and what a small group cannot do

The pharmacovigilance group's new activities and ongoing updates were, in its chair's words, the direct product of the committee's reshaping, with everybody doing their best to support the committee. ⁵⁸ The first thing the reshaped group discussed was redistributing the background tasks, from planning its future updates and expert seminar sessions to smaller tasks such as regular updates of the website and of the pharmacovigilance guidance, among the committee members and some of the most active supporting volunteers. ^{58, 59} It also tried to expand its pool of contacts through each member's professional network. ⁵⁹ Its first big visible change, in early September 2017, was a major update of its web page, which was redesigned to align with the regulatory public disclosure group's page and given a major content update. ⁵⁹ All the committee members and supporting members coordinated the work, contributing from their own experience and areas of expertise. ⁵⁹

The group's members all do its work in their spare time, because, in one founder's words, they love it and it is what they work in. ⁷ Because the group's work is a volunteer activity done alongside its members' everyday working lives, the group thought it would be good to have its committee members and supporting members contribute to EMWA's monthly Newsblast. ⁶⁰ They provided news based on their daily jobs, a collaboration the chair said worked well, and a few issues had already carried relevant pharmacovigilance topics and guidance news. ⁶¹

The group also set out to offer more workshops at EMWA conferences and more articles, and one of its supporting members volunteered to prepare an article. ⁸ A group of its limited size cannot do this on a very regular basis, but it tries to increase the offer and welcomes suggestions from all EMWA members, not only from those taking part in the group. ⁸ Its first chair asked members to tell the group what they need, by email or through the EMWA website, and said the group would do whatever it could to meet that demand. ^{62, 4} The group lives on contribution, its chair added, and is not only about learning for EMWA members but much about sharing, so experienced members should feel encouraged at least to contribute possible topics and resources that EMWA could offer to less experienced members, which would add value to the group's activities. ^{62, 63}

A small group's standing output and aims

In September 2019 the pharmacovigilance group was a relatively small group, with five people on its committee and about six to eight in its pool of supporting volunteers, all of them interested in and working in pharmacovigilance. ^{9, 64} It organised conference activities related to pharmacovigilance: it normally developed and gave workshops and sessions on pharmacovigilance within the expert seminar series at the spring conferences, and that month it started webinars on pharmacovigilance content. ⁶⁴ It tried to contribute journal articles about pharmacovigilance in a quite regular way, and every month it provided the latest regulatory news on safety and pharmacovigilance writing in EMWA's Newsblast. ⁶⁴

Its aims were to train members and to address needs of EMWA's membership, such as understanding the concepts of pharmacovigilance and risk management and the corresponding regulatory requirements in the lifecycle of a medicinal product, and learning how to apply the regulatory guidelines for preparing the main pharmacovigilance documents, the development safety update report, the periodic safety update report and the risk management plan. ^{64, 65} It also aimed to update members regularly on relevant regulatory news and new guidelines, and, very importantly in the group's words, tried to facilitate a direct dialogue between EMWA members and regulators by inviting representatives of health authorities to the expert seminars and to the symposium sessions it organised at the conferences. ⁶⁵ Members interested in supporting or cooperating with the group were asked to contact it through EMWA's head office, and the group said it would be very happy to broaden its network. ^{65, 66}

A programme built with other groups and with the regulators

One of the pharmacovigilance group's early aims was to encourage collaborations both within and outside EMWA. ⁶⁷ EMWA's offering in pharmacovigilance was not large at the start, so the group asked potential workshop leaders to develop new workshops in the area. ⁶⁷ It also collaborated on a joint symposium with the transparency and disclosure group, the only other special interest group then existing, and proposed a pharmacovigilance session to the expert seminar series subcommittee. ^{67, 68} It told the MHRA and the EMA about the group, explained that its aim was to increase discussion with them and asked for their input. ⁶⁸ Both were very willing to engage, and they came regularly to present at the group's seminars and symposia. ⁶⁸

The group's updates at the spring conferences included talks from the regulatory authorities and other speakers. ²⁵ It presented its first expert seminar session in Birmingham in 2017, with presentations from the regulatory authorities. ⁶⁹ That session went down so well that the group proposed to the executive committee that it would produce a pharmacovigilance expert seminar session at every spring conference, turning its update into that session, and it had planned the sessions through to 2020. ⁵⁰

The group committed to one expert seminar session a year, but the series was itself evolving, with one more session that year than the year before. ⁷⁰ With so many hot topics to address, it might not always be possible to dedicate a session to the group. ⁷⁰ New groups had also been founded, among them one on medical devices, so the group might need to reformat its update and, as it had done before, prepare a session within a symposium. ^{70, 60}

By September 2019 EMWA had five special interest groups, on pharmacovigilance, regulatory public disclosure, medical communication, veterinary medical writing and medical devices, and its president described them as contributing greatly to planning the expert seminar series and the symposium held at each May conference. ³²

In September 2022 the sustainability and pharmacovigilance groups held a webinar as a joint initiative, which the sustainability group counted among the key points of its programme that year. ^{71, 44} The sustainability group's work also covered aspects of EMWA being a United Nations sustainability partner organisation, EMWA's ecological footprint, and a section of Medical Writing, The Crofter, updating medical writers on the healthcare industry and sustainability and on how to communicate sustainability information. ^{44, 72} It announced its next group meeting for 7 October at 9 am CEST and its first expert seminar, on 4 November at the November 2022 conference, titled "Sustainable medical communications: from awareness to action". ⁷³

Informal formats beside the formal ones

The idea for the pharmacovigilance group's first lunch roundtable discussion, planned for the Barcelona conference of May 2018, came from a supporting volunteer who raised the need for EMWA's pharmacovigilance writers to discuss, network and share their own experience. ^{61, 8} The group decided to keep it very informal, with two or three topics for discussion, so that any EMWA member could pass by during lunch to see who belonged to EMWA's pharmacovigilance sub-community, network and share experience. ⁷⁴ The speakers from that conference's pharmacovigilance expert seminar session would probably also take part, and members were invited to network with colleagues and put their questions to the speakers. ^{74, 57} The committee's face-to-face meeting and its first meeting with the supporting volunteers were planned for the afternoon of the same day. ⁵⁷

By September 2022 the pharmacovigilance group had grown a lot since its founding in 2015, with a number of committee members and supporting members. ⁷⁵ It had a strong presence at EMWA conferences through workshops at both foundation and advanced levels and through the expert seminar series. ⁷⁵ It also offered members relatively regular meet-and-share sessions for the informal exchange of experience, usually with a couple of invited speakers followed by discussion with the audience. ⁷⁵ Its next meet-and-share session, on 26 September 2022, was to focus on the developmental risk management plan. ⁷⁵

A working group across the groups

By June 2025 EMWA had established an AI working group, with each special interest group appointing a dedicated AI liaison. ⁷⁶ Its activities had included a full-day AI symposium in Valencia, follow-up webinars through the year, and virtual conference sessions featuring publishers' perspectives on AI, with input from editors at The Lancet and JAMA. ⁷⁶ Its ongoing aim was to help members be better informed and more confident when discussing AI with research authors, agencies and clients as the field evolves. ⁷⁶