TGA Advisory Committees: Information for prospective applicants

Speaker Key:
SS Sarah Syme
RL  Professor Robyn Langham
AS  Professor Anne Simmons
JM  Ms Joanne Muller
H   Host

00:00:01
SS Professor Robyn Langham, is a former member of the Advisory Committee on Medicines. She's also the Chief Medical Advisor of the Therapeutic Goods Administration, is a nephrologist and a clinical researcher. Professor Langham is also a director of the Australian Medical Council and chairs the Human Research and Ethics Committee at the Royal Children's Hospital in Melbourne. We also have Ms Joanne Muller, who is a member of the Advisory Committee on Medicines. Ms Muller has been a consumer and community representative in the health sector since 1994, and holds formal qualifications in science, teaching, law, and governance.

00:00:38
She currently sits on a number of statutory bodies and working groups, with a focus on health, and has over 35 years’ experience in non-executive director roles in a wide variety of organisations, including serving six years as the legal member of the Cancer Council Ethics Committee, a Human Research Ethics Committee, registered with the NHMRC, and is an occasional lecturer on ethics and law for health students  at two universities. In the 2023 Australia Day Honours, she was appointed as a member of the Order of Australia for significant service to youth, community health, and the law.

Professor Anne Simmons is the Chair of the Advisory Committee on Medical Devices. Professor Simmons is Emeritus Professor of Biomedical Engineering at the University of New South Wales, where her roles include Provost, Pro-Vice-Chancellor Academic Excellence, and Head of the Graduate School of Biomedical Engineering. She's a fellow of the Australian Academy of Technology and Engineering, a fellow of the Institution of Engineers Australia, and received an Order of Australia for contributions to biomedical engineering. Professor Simmons serves on various government committees, offering her expertise in biomedical engineering and biomaterials.

00:01:50
Just a reminder that questions will open, but not until we're a little way through, and they will be moderated, so please bear with us while we put those up on the screen for people to vote on. Okay, this webinar is a really good opportunity to hear from current and past members of statutory advisory committees and gain firsthand insight into the role and expectations of committee members.

We will not be discussing the application process in detail during tonight's session. However, we will touch on it at the end of the webinar, and we'll also provide contact details for anyone to ask any questions. There's also some frequently asked questions that will be on our website following the webinar, and the details will be available through the published material. We have seven statutory advisory committees that provide independent expert advice to the TGA. Diversity in membership is very important to us, and advice provided by these committees is a really important element of the regulatory functions of the TGA.

Members are paid in accordance with the provisions specified in the Remuneration Tribunal Determination of 2024. The current daily sitting fee is $1,291 for a Chair and $971 for a member. The official travel determination specifies the general provisions for travel expenses and travel allowance for committee members.

00:03:24
Our meetings are conducted in a range of ways. We have in-person meetings, which can be held at the TGA offices in Fairbairn, which is in the ACT. Virtually, via MS Teams, or in a hybrid way. We sometimes have meetings at some of our state office locations, so it's not always Canberra. And we have a table there on the screen about the expected number of meetings per year. 

Applications should be submitted through the Department of Health and Aged Care, and they're open for approximately six weeks. They will close at 11:30 on Tuesday, 3rd June 2025. They should be submitted through the Department of Health and Aged Care Vacancies website, which is being included in the chat now. We expect that applications include a cover letter stating the relevance of your expertise. A preference for one or more committees, a current curriculum vitae, a short biography, a fully completed and signed Declaration of Interest. Contact details of two referees, and your contact details.

From there, we will conduct an assessment process, and we'll take into consideration the specific fields of expertise required for each committee, geographical diversity, cultural and linguistic diversity, and the government's gender diversity target, which is currently that women hold 50% of positions on government appointed boards. The Minister will select the new members, and they will be appointed, with their term of appointment commencing on 1st January 2026. Induction sessions for new members will be conducted in November and December of this year. Unsuccessful participants will be notified following the new member appointment process.

00:05:15
Members are appointed to provide professional input in relation to matters coming before the committee, based upon their specialist knowledge and expertise. From time to time, conflicts of interest may arise when a member's personal interests conflict with committee duties, so that the member may not be, or perceived to be, independent, objective, and impartial, in relation to those duties.

For this reason, we require new members to sign a Deed of Undertaking, in relation to confidential information, and a Conflict of Interest upon appointment to a committee. There's further information available on our website, but we do acknowledge that in order to have sufficient expertise to be successful in this appointment process, that means you have a range of personal and professional obligations, and we do take that into consideration. I will now hand over to Professor Robyn Langham, and she will introduce herself and provide some insights into the role and expectations of committee members. Thanks, Robyn.

RL Thanks, Sarah, and welcome, everybody. I'm also on the lands of the Ngunnawal People this evening. I do want to specially thank both Jo and Anne for their time this evening. Everyone else that's online, we're part of the business here, so thanks to Anne and Jo for taking time out of your busy schedules and your private lives even, to share your experiences of work on the advisory committees.

00:06:44
I suppose I feel myself as a great example of the really exciting nature of working on advisory committees, because that's how I started, in terms of my relationship with the TGA. And since then, I've really been able to understand the work of the TGA greater, and perhaps the relative or the special role that the advisory committees play in the work of the TGA.

The TGA is full of a whole bunch of expertise in regulatory science, governed by a really a complex set of laws and legislative background that help guide us, in terms of deciding, to a large extent, the safety, quality, and efficacy of products, and whether they can be registered and made available for the Australian community. But there's also other committees that deal with things, such as scheduling and access from a complementary medicine side of view. We are a risk-based regulator, and that's often where our advisory committees come into play. The advisory committees are there to provide advice to the regulatory scientists, if you like, of the TGA.

For a straightforward, let's say, blood pressure drug application, where there might be a need for some advice in a specific speciality area, or, most importantly, a need for some advice from a consumer about the sorts of effect of therapeutic products might be having. Then, these products are brought, or the questions about these products are brought, to to the scientific advisory committees, in order to enrich our understanding and to help inform, mainly around the risks of the product to the community.

00:08:47
Why would you do it? I was told when I went to my first information session about the Advisory Committee of Medicines in 2000, sorry, it was a long time ago, that this was, effectively, and I agree with it, the best journal club in the world. You have an opportunity to be at the real cutting edge of the newer products that are coming through to the market, to be able to build new networks of new specialists, new friends, new knowledge.

And certainly, I found it really rewarding, even just at the contribution of the advisory committees, to be able to make a contribution, and to be able to make a difference to patient care, and how Australians experience their health journeys, on a national level, which was certainly a lot different than the one-on-one experience that I had had as a doctor, in my clinical years.

I guess, also, I want to reassure everybody, and that is that we're not looking for experts in regulation here, but we're looking for experts in particular areas of health care, of community knowledge, of, sometimes, engineering and biospecimens knowledge, as Anne will attest to. The whole process of being on an advisory committee is a very, very supportive one. I remember, there are no questions too stupid to ask. Those stupid questions are always asked in a very supportive environment, and in the understanding that these questions that are asked are also probably wanting to be asked by a lot of other members in the committee. And are done so, again, with the opportunity to enrich, and advise, and support decisions that are the work of the TGA.

00:11:00
I don't want to say any more. I think what I'll do is, I'll hand over to Jo, and Jo can tell you about her experiences on the advisory committee, from a consumer perspective.

JM  Thanks so much, Robyn, and good evening, everyone. I'm joining you this evening from the lands of the Gadigal People, and so, I pay my respects to their Elders, past, present, and emerging.

I'd really like to thank the TGA for this opportunity to talk about the role of a consumer health member on the TGA Statutory Advisory Committees. I'm in my fourth year as a member of the Advisory Committee on Medicines. And I've also attended a couple of meetings of the Advisory Committee on Medical Devices, and also one on the Advisory Committee on Vaccines. I've had a fair array of the seven advisory committees. I've thoroughly enjoyed every one of them.

Under Part 6 of the Therapeutic Goods Regulations, the membership of each of these advisory committees may include a member with expertise in consumer health issues. And I've done my due diligence and research, and every one of those committees does have a consumer health expert. They really do take seriously the commitment to having the consumer voice at the table.

00:12:42

Stakeholder inclusion in this regulatory process is, of course, now what is expected as best practice, so the inclusion of a consumer health focus promotes the consumer perspective, being squarely at the decision-making table.

Now, when I say decision-making table, we're only advisory committees, but we usually have a consensus on what advice we're providing, and that consumer voice is very squarely at the table of all of the meetings that I've been at. And so, we're providing that advice, and it flows through to improvements in the quality and safety of health care in Australia. So that really does make it the very rewarding work that Robyn described.

Before I come to some specific details, I just wanted to share a little anecdote from my very first meeting of the ACM, which was in early 2022, and we might remember that they were years of COVID. It was an out-of-session meeting, so it occurred fairly soon after my appointment, and it related to a COVID medication.

The papers I received were incredibly well presented. I received excellent IT support to get me up and running, and the meeting was so very well supported by all of the staff that I could not have asked for anything more. It was probably the best supported meeting I have been to and through our many years of going to meetings.

00:14:31
The discussion during this meeting was rigorous, respectful, and challenging, all at the same time. Another small indulgence of an anecdote was an absolute thrill I had about 18 months ago, when I saw on the news that a particular drug that I'd asked the silly question about... But of course, it wasn't a silly question, and it was certainly not treated as a silly question.

But I asked a question about a particular medication, and it made everyone stop and think, and as a result, we had further discussions and that drug was approved, and it was making a difference to the lives of a significant number of, in this case, children. And I was absolutely thrilled to know that I had played a tiny part in getting that drug out to the Australian health sphere.

Back to the early days of the meeting. What I had found then, and what I have continued to see, is the absolute dedication of each member of that committee, of all the committees. It's palpable. You can feel it throughout the meeting, even when the meetings are held electronically.

The expertise of the committee members is clearly of the highest calibre. And I don't mean that in terms of being the absolute expert on everything, but each person is contributing their very best, and listening, and really hearing what everybody says. The bottom line of this work is, it's real work. There are real benefits to the health of Australians. And so, quite clearly, I'm hooked on this work, and I find each one of the committees equally intriguing and rewarding. Let's get down to some expectations of the role.

00:16:38
There is a large amount of reading, and so you do need to set aside the appropriate amount of time for reading the papers prior to the meeting. This is certainly not a kind of meeting where you can wing it and be reading through the papers as you go, because there are sometimes a great deal of reading.

Of course, as you become more experienced, you will become more targeted in your reading. And as the consumer person, you're not expected to understand absolutely everything, but you really do need to be across what are the issues, what are the concerns, so that you can apply your consumer health knowledge to those areas. I pay particular attention to the consumer medicine information sheet because that's the document that most consumers will engage with when they are either having a new medication or a change of dose, or they've just simply forgotten something and want to go and check. I also focus on unmet health needs out there in the community, and I try and make that contribution to the deliberations of the committee.

Apart from the ability to read and digest things, I think having an understanding of some recent research papers of clinical trials and scientific materials, just a basic understanding. And I find that I will Google words, so I'll come across a word that I've never ever seen before, and so, Google is very helpful, and you go, oh, yes, I understand what that means. Don't get just get stuck on a word, just Google it and you'll find out what the word means, and then you'll put it into some context.

00:18:41
You need to do sufficient reading, so that you're in a position to ask informed and relevant questions, and make comments from the consumer health perspective, that are meaningful and that are relevant to the particular item that is being discussed.

Sometimes you might not say anything about a particular item, but other times you might have lots of questions and lots to contribute. You'll find that the other members of the committee, who are all clinicians, are very, very respectful of the consumer voice, and there certainly is none of this, oh, well, that's a silly question. I've never ever been made to feel silly or inadequate in anything that I've asked. And if I haven't used the correct terminology, I'm not corrected, per se, but it may be rephrased amongst the clinicians, so they understand what I'm talking about. It does really pay to have done your homework for all of these committees. Insight into what are the current concerns of health consumers, is something that you will need to have the ability to stay up to date with.

The work also involves being able to work in a very, very wide multidisciplinary team. You will find that the clinicians that you are working with, come from a variety of different spaces within the health system.  And so, you do need to have those skills of working with a multidisciplinary team and of integrating their comments and distilling the complex issues, so that you can contribute.

My advice to applicants is, only apply if you have sufficient time to fulfil these roles, because these roles are actually too important for you not to devote the time that is required. Please only apply if you've got sufficient background in understanding the Australian healthcare setting, because really, you do need to know about where the TGA fits in, where medicines and devices, and things, are.

00:21:04
But you will also receive quite a lot of information in the induction, so having some basic knowledge is there, you need to have that, but then, the induction process that you will be offered, should you be successful in the role, is an excellent process. The ability, as I've said, to read fairly complex documents and to put the consumer lens over it is also important. For me, it's been an absolute privilege to serve as a member of the ACM, and having to be appointed for a second term was even more exciting. I found the work very rewarding, and I wish you all very well, should you make the decision to apply for these roles, they are amazing. Thank you. I'm handing over to Anne now.

AS Thanks, Jo. And thank you, Sarah, for the very kind introduction. Good evening, everybody. As has been mentioned, I've been the Chair of ACMD, which is the Medical Devices Committee, for nearly ten years now. And I'm going to talk quickly about the role of committees, the committee procedures, and the time commitment that's required from members.

00:22:27
As has been said, the role of these committees is to provide advice to the TGA about specific devices, medicines, and other therapeutic goods, where the TGA feels that they need additional input from experts in the area. As Robyn said, the TGA has a team of medical officers, engineers, pharmacists, and a lot of other disciplines, who all do an amazing job. But sometimes they need specific advice from an external expert in the area, to help their deliberations.

On my committee, on ACMD, for example, we've got broad representation of specialities relevant to medical devices. We have orthopaedic surgeons, cardiac surgeons, cardiologists, gastroenterologists, EMT, anaesthetics. We've got biomedical engineers, we've got human factor specialists, microbiologists. And of course, our incredibly important consumer representatives, who often just bring us straight back down to ground when we go off on a wild tangent, but very important people for our committee.

The members that we have are experts in their specific area, but we all contribute to the general discussion in all areas. And that cross-disciplinary nature of the committees is a very important factor in the quality of the advice that we ultimately provide to the TGA. We can't have a specialist representative on every committee in every area, so we frequently invite external experts in, to assist with the advice. For example, if we're looking at a neurological device and we don't have a neurologist on the panel at the moment, we bring in a specialist neurologist to assist.

As has been said, we don't make regulatory decisions. We provide very considered advice to assist the TGA in making those decisions, so you don't have to be an expert in regulation. That's the TGA's job. That said, you learn an awful lot about it in the time that you're on these committees.

00:24:37
And I have to say, the TGA secretariat, the medical officers, and all of the staff that we deal with, are absolutely exceptional. The papers are good. They're long, and I'll talk about that in a minute, but the papers are fabulous and the support is great. It’s a very supportive environment, and you bring your expertise to the table, and we have discussions and provide advice.

In terms of the process, I'll use ACMD as an example. We have six meetings a year. Each meeting is usually a full day. We have them in person, we have them online, and we often do hybrid meetings. Personally, I prefer them in person, because the quality of the discussion is much better when everybody's around the table and you can sense the feeling in the room. You can see the body language, you can see who wants to say something but maybe doesn't want to say it just then. But it's much better to have it in person. That said, we do it online, and we do it on hybrid. If it's in person, often times we meet in Canberra. More recently, we've been meeting in Sydney, as well, and that turns out to be very good for people flying in from interstate, a little bit easier than Canberra. And we have experts from all over Australia, so there's some travel. 

00:26:05
The experts in Perth, and say, far North Queensland, stay a night before the meeting. But other than that, it's in and out in a day. Usually for ACMD, we have six to eight topics for the day, and specific devices, advice on specific devices, as well as general policy advices on groups of devices  if the TGA requires that. 
Each item has a dossier of information prepared by the TGA, it contains information from the sponsor, such as clinical trial data, preclinical data, details of devices that the sponsor believes are equivalent, all sorts of information assessments, and multiple assessments by the TGA medical officers, correspondence backwards and forwards to the sponsor.  And then, a set of specific questions that the TGA would like advice on. You really need to read the background information, to understand what the questions are that the TGA are asking. Having said that, they do let us provide advice outside those specific questions, and often we do, because we can't help ourselves. 

We get very complex questions, we get very complex issues, and that's the nature of the advisory committees, it's when the TGA medical officers come to a grinding halt and say I think we need to ask them this question. Often, they're quite complex questions, and the way we do it is, one or two committee members, or the external experts if we've got them that day, will present the item for 10 to 15 minutes, and then there'll be a very full discussion by the full committee.  And then at the end of that, we provide written advice from the committee to the TGA. It's about 30 to 60 minutes per item, average is about 45. As Jo said, the discussions are collegial and respectful, but they are very rigorous and they are very thorough. It’s a very supportive arrangement, but we do have very rigorous discussions, and everybody gets their say, and we provide advice, based on everybody's advice. 
 

00:28:18
In terms of time commitment, it comes in bursts, with six meetings a year. If you're presenting an item, then it's going to be several hours to read all the TGA papers and prepare a presentation. 
The other good thing about having experts there, too, both on the committee and external, is that they draw on their experience and knowledge in the area, like recent publications that possibly haven't been found by the TGA, overseas meetings, where trends are being observed, but they haven't been published yet. All that information feeds into the discussions. 

If you're not presenting, it's going to take you, still, four to six to eight hours to read the papers for all the items, a full day for the meeting, and then an hour or so to review the minutes and the advice that we've provided.  That said, meetings are scheduled the year before, so by December of the year before, we know the dates of the six meetings. And it's really, really important to set aside those days, that you have to commit to those days, for your advisory committee meeting, and possibly, some time beforehand, schedule it into your diary to do the reading required. 

00:29:36
In summary, the committees assist the TGA to do very, very important work, and in the process, we're all contributing to the health and wellbeing of all Australians. On these committees you'll meet some really exceptional people, not just in terms of their expertise, but also their willingness to contribute to the TGA and its important role in our society. 

I actually roll off my committee at the end of this year. I have found the work incredibly rewarding. I've learnt so much over the past nearly ten years, both from the TGA staff, as well as the committee members I've had the honour of working with over that time. 
I've made some really good friends, and I've ended up with a network of exceptionally talented but genuinely good people across Australia. These are people who want to give back to their discipline and their community, so they're not only experts in their area, but they're good people.

If that sounds like you, I urge you to apply for a role on the committee that best suits your experience and expertise. And with that, I'll hand back to the TGA for Q&A.

H Thank you so much, Sarah, Jo, Robyn, and Anne. We will quickly go back into the PowerPoint presentation.

SS   It’s coming, Nishie, my apologies.

H No worries, thank you. We'll do a quick refresher on Slido, on how to use Slido, while our speakers take a very quick break so they can prepare for Q&A before we head into it. In the meantime, here is a very quick refresher on how to use this.

00:31:31
Again, for those who missed it, to ensure the panel receives your questions, please ensure you put them on the Slido function and not the chat feature. Firstly, you can access Slido by using the app icon located lower-right off your screen, as shown on this slide.

Secondly, you can scan the QR code, by using your mobile device. And thirdly, you can use the link we have placed on the chat, to access Slido using your computer browser. Noting that todays’ questions are being moderated, so please be patient as we do moderate. Once the questions are visible on the screen, you can upload a question, and it will prioritise the questions in the order of maximum votes.

Also, a quick reminder, we do have a short survey, a feedback survey, opened up, as the speakers get prepared, you can use the Slido in the same way, and please just complete the feedback survey, in the meantime. And once the speakers are ready, we can hop into Q&A. Thank you.

SS  Started. Oh, there we go. Thank you. Let's head into the questions. Firstly, I so just want to acknowledge the very kind comments from both Joanne and Anne and the work of my team, and the work of the TGA staff. It's really lovely recognition for them. They do work incredibly hard, and it often is just a little squirrelly stuff in the background that goes largely unrecognised, so thank you for that.

00:32:57
But also, thank you for your contributions over a large number of years in your respective committees. We really do appreciate the willingness of you to put your hand up for another feather in what is already a very full cap. We do appreciate your time. Let's go to some questions. We've got them coming through. Please do vote for the ones that you want most heard, but we'll start with one.

This one is, what challenges are being faced for an advisory committee member that comes from working within the industry that the committee represents? And I think we did talk a little bit about this throughout the presentations, but I know, Anne, you were discussing this a little bit, so if you're happy to take this question.

AS  Yes, I'll certainly start. I'm pretty sure Robyn will have a comment on this one, as well. We take conflicts of interest incredibly seriously. We look at conflicts and perceived conflicts. We have to fill in an annual declaration about our conflicts of interest each year, and then ahead of every meeting.

Working in the industry, I feel would be quite difficult. It would be a source of some conflict of interest. I think we would look at it on a case-by-case basis, and the Chair and the TGA look at every single Declaration of Interest on a case-by-case basis. But you should be there as an expert in your particular area, and if that area involves you working in the industry for that area, I think it might be a bit tricky. But I'll hand it over to Robyn for more comment.

RL Yes, thanks, Anne. Look, it's really on a case-by-case basis, as Anne said. And certainly, in the medical area, where most doctors in their speciality will have been involved in a clinical trial. Most doctors of a particular speciality, particularly when we're talking about really rare diseases, often really niche areas, it's going to be virtually impossible to find an expert who's not somehow involved in that industry, if you like, of being involved in the drug development.

00:35:31
There are various graded ways in which a conflict can be dealt with, as well, and Anne is very familiar with. In some cases, yes, there's a conflict, but this can be managed, by allowing the person to stay in comment, but not vote, should there be a vote.

In some situations, however, and that's the situation where someone's been employed on an advisory committee, then it would be felt best for them, that person, not to be present during the discussion. All conflicts, absolutely, should be declared. They are managed, and they're managed in, I think, a proportionate manner by the Chair, and are often done so in advance. Our understanding that as the questions become more niche, we understand that there has to be an element of tolerance in order for us to be able to get that expert advice. I hope that's answered the question without actually answering the question.

JM  And maybe if I could just add that it's a very thorough process that occurs at every meeting, so that I am aware of the conflicts of interest of all of the people in the room and any of the external experts. And so, we're all actively involved in the decision making, in relation to how to manage that conflict of interest, and so that we are aware of it. It’s a very proper process that is adopted, for managing conflicts of interest. Thank you.

00:37:08
SS   Thank you. The next two most highly voted questions are somewhat similar, but in terms of expertise that we're looking for, if you're a hospital pharmacist or an allied health practitioner who works in the industry, is it worthwhile you applying for the roles, or is it really only medical expertise that we're looking for?

RL   I can answer to the different statutory committees. Absolutely. There's roles for all sorts of people. And certainly, on our scheduling committee, the roles of pharmacists are critical, and we're not, by any stretch of the imagination, just looking for doctors. Anne can talk to some of the specialists that sit on her Advisory Committee for Medical Devices.

In the Advisory Committee for Medicines, it's by and large medical specialists, obviously, with the support of consumer input. And we do deliberately go and find a clinical pharmacologist expertise for us, as well, because not all of us are that close to our teachings on pharmacokinetics and pharmacodynamics, let's just say.

It does depend on the committee, and if you're interested, and you put your hand up, and you have expertise and value for us, then certainly, you'd be considered for a particular role.

00:38:27
AS  And just to follow on, with medical devices, obviously, we have all the medical specialities in the room, but we have three biomedical engineers, we've got a human factors expert. We've got a microbiologist there. Anything that's relevant to the particular therapeutic good that the advisory committee is there for, really helps the discussions. We don't particularly have pharmacists, but we do have a lot of other allied health people, so don't let it put you off at all.

SS  Thank you. The next question is around expectations as to the level of experience for doctors. This person's very interested in applying, but it’s early in their career as a medical specialist.

RL  Well, that's a really interesting question, and I guess it comes down to the sorts of expertise and the sorts of questions that you will be be asked. And sometimes they do relate to effects on a patient community as a whole, and I guess it's fair to say that that level of experience comes with a certain period of time working in the community.

And so, I would say, if you were quite early in your career, and by that, I mean in the first couple of years since you finished, then maybe this is not the time for you to apply for the Advisory Committee of Medicines.

00:39:57
However, if you're someone that's been involved from a research sense in drug development and have been involved in clinical trials, and you have a level of expertise, then absolutely, that may be something that we're looking for as well. I don't want to discourage people from applying, but we are looking for, certainly from the medical specialist side of things, a level of experience to help inform us.

SS   Thank you. This one might be best directed to Joanne, any considerations or support for people who are not necessarily as highly experienced as committee members?

JM  Well, I think it's not so much a matter of whether you're experienced on a committee, per se, but whether or not you are able to work in this team of people. It is an interesting committee, because what we're doing is, we are, essentially, merely doing the same thing for a different drug, a different drug, a different drug, or a different device, different device, different device.

It's not like a committee that might be dealing with a whole range of different things, and so, you need to engage in different ways, or a board where you'll be doing finances, and risk management, and a whole range of things. I don't think you need to necessarily have experience on committees, but you do need to be able to work with a range of people in a collaborative way.

As I think Anne, in particular, mentioned, that we do have very rigorous discussions. There are differences of opinion, in terms of coming at it from different directions. But it's the collegiate and collaborative manner, and respectful manner, in which those discussions happen, which allow for the issues to be distilled out, the issues to be narrowed down, and for the discussion to focus on, if you like, smaller and smaller elements of the question that we've been asked. And then to come to a consensus.

00:42:18
And I think that does take a certain skill, and it is a skill you probably do learn on committees. It’s not quite a Catch-22 situation, because I think you can have those skills if you have worked in a multidisciplinary team, for example. If you're used to working in that environment, where you're moving from a client, or a patient, one patient to the next, to the next, and you're working with social workers, occupational therapists, physiotherapists, medical practitioners, etc., and you're used to that rigorous discussion.

Also, there is a time limit on these. Whilst we certainly run over time, we don't run necessarily exactly to schedule, because we devote enough time to each matter. And usually, we make up time with other ones. We always give everything sufficient time to give a proper answer. But you need to be able to move from matter to matter to matter. I think it depends on your skill set, and you can get that, otherwise, then, on a committee. And I hope that helps the people who asked the question.

SS   Thank you. Excuse me, are the time commitments similar for each type of committee, e.g., medical devices versus medicines committees? I think I would note, firstly, we did talk about the schedule across the year being a bit different for each of the committees, so perhaps if the answer can focus on preparation time and pre-work, and things like that, of your experience across the different committees.

00:44:07
RL  Let me, let me start with the medicines. Maybe as a member, and I never chaired, but I think it varies from meeting to meeting. For example, there would not always be a specific medicine that would come through for the nephrologist to be able to prepare a thorough background response for the rest of the committee and specifically answer the questions.

However, and because of the kidneys’ role in often how you deal with drugs, I would be scanning and skimming all of the submissions that were coming through, so that I could be prepared to answer those from a renal perspective.

I think for an individual member, you might find that it's a little bit patchy from meeting to meeting, but you would certainly expect two to three hours of reading before each meeting, would be considered adequate. Anne, you spoke to the sorts of time that are involved with the medical devices.

AS  It's not dissimilar. I think it probably varies outside medical devices and medicines. Some of the other committees meet less times during the year, so I think the time required, just because of the lower number of meetings, would be less. But we would spend four, six hours before every meeting.

If you're presenting, as Robyn said, it's a different kettle of fish, because you do have to wade through a lot of documentation and do a presentation. And it's really, really important that you commit to that time because everybody has to be involved in the discussion at the end, and everybody has to understand what the issues are, so that we can pull it all together.

00:46:02
JM    And if I can add that the Advisory Committee on Medicines frequently meets for two days. And so that's when there is a large number of drugs to be considered. And so, the reading is obviously higher, and the commitment is higher. On some occasions, we can manage to deal with all the applications, or all of the requests for advice in one day. But you do get a list of the drugs that are proposed to be discussed at the meeting well ahead, and so, you will have an idea of how long the meeting is going to be.

And so, you're asked to fill out a Declaration of Conflicts of Interest at that time, so well ahead of the meeting. And so, at that time, I always take a note of how many. Apart from reading the drugs and making sure there are no conflicts, I also take a note of how many there are. And so, I do a mental arithmetic on how long it might take me to read, so I make sure I put aside that time.

Usually, you have the papers for at least two weekends beforehand, so even if you're working full time, you should be able to find the time to read the papers adequately.

SS  Thank you. Just to remind everyone, we've got about eight minutes or so left, so please keep your questions coming through. There are a couple of really easy-to-tick-off ones in the list. How many members are on each committee? The team has given me those numbers, and they're about to post those in the chat, rather than me reading them out to you.

00:47:55
And there's also another question about how many applications we receive, compared to the number of committee vacancies we have. This year, we have 47 vacancies that we are looking to fill, and numbers of applications vary, up to around 200.

There's a really good process of assessing those and going through, and a very impressive spreadsheet that the team pulls together with all of the skills, and everything. It's quite a fun process to observe the way we align those skills. Yes, that's all done. This one might best go to Robyn or Anne, but is there an intention to focus on digital therapeutics? And if so, which committee would this sit under?

RL   I don't think there's any intention to focus. The role of the advisory committees are to deal with questions of specific products as they come through. And if there is a digital device, an AI product, a software, they are medical devices, and Anne’s committee deals with that if there is questions by the evaluator.

And bear in mind, as we've said, we've got some incredibly experienced staff at the TGA that have a lot of expertise in this area, so if there are questions or concerns or advice around the risk of particular products, then they would come to Anne’s committee and medical devices, by and large.

AS Yes, just following on from that, we had a meeting, I think, two meetings ago, where we had four AI-related devices. It was quite overwhelming. And AI’s been around in medical devices for a long time, in various forms, but it's coming like an avalanche now.

00:50:03
SS    Great. Okay. The role of RNA therapeutics specialists in TGA biological and vaccines?

RL  I might try and answer that one. Again, we've got a number of medically trained people, laboratory people, that are experts in RNA therapeutics within the TGA, and they would be involved with the evaluation. But if there's a product that requires additional advice around risk management or effects on a particular subset, or whatever, then it would likely come to either the Advisory Committee for Medicines, if it's a therapeutic, if it's a medicine, or it would go to the Advisory Committee on Vaccines, if it's going to be a vaccine. 
And there are a number of different specialists involved in that advisory committee, as well, be they infectious diseases or clinical trialists, or so forth. The therapeutic specialists would fit in either the Medicines or the Vaccine Advisory Committee. I'm hoping that's the question.

SS  Great. Four minutes left, so we will see how long the answer is to this, if we get another one in. But when providing advice from the committee, is the discussion and decision, essentially, based on synthesised evidence and committee expertise, or a mix of both?

00:51:41
RL   Our role as a regulator in evaluating products is guided by this legislation, which is the Therapeutic Goods Act. And that's very clear in the sorts of evidence that needs to be submitted by a sponsor in a dossier, to demonstrate that a product is safe, quality. Safe, it’s high quality, and then it works.

So far, and I think I can speak for other global regulators around the world, synthesised evidence or synthetic data is not part of that, and the evidence that's needed is evidence that comes from clinical trials, and that's for a new product. If we're talking about other alterations, then certainly, we can start looking at real-world evidence and the evidence that's been presented by the sponsor.

The sorts of things that the advisory committee is being asked will depend on the specific question about that. But the evidence that's been provided will reflect that, that's been submitted by the sponsor. I hope that answers the question. 
And sometimes, and certainly happened in my time on the committee, the committee will disagree on a particular question, and sometimes this comes down to a vote as to what the decision of the advisory committee is.

And I think it's really important, as well, as an advisory committee member, to be mindful of the fact that we are just giving advice and that the final decision about a registration or not of a product, or the down scheduling of a product or not, is not just dependent on what the decision of the advisory committee is, but the decision about the questions that are being specifically asked. Hope that helps.

AS  And, Robyn, just adding on to that, the medical officers from the TGA are actually on the call or in the meeting when we're discussing it, so they're hearing all of the discussions. Medical devices rarely goes to a vote. In fact, I can't remember going to a vote, but medicines might be different. But they hear everything we say.

00:54:01

RL   Yes.

AS   They're also synthesising all that information that's being just put on the table during the discussions. We provide written advice at the end, but it's at the end of a 30-minute rigorous discussion.

RL  And often there's opportunity for that medical officer at the TGA, who is the evaluator, to ask and interrogate further if the advice that's been given is not quite clear, so it's a live process.

SS  Thank you. Two questions, so we might try and knock them off really quickly. Putting conflicts of interest aside, and I guess assuming it can be managed, are engineers and product developers of medical devices encouraged to apply, even if they're working in the industry?

AS     So that was the sort of question I was answering before. Not the medical specialists, but people who are actually working in the industry. I think that, as Robyn said, it's on a case-by-case basis, but if you're working for one of the sponsors, even the perceived conflict of interest, it will be tricky to assess. But, Robyn, what are your thoughts on that?

00:55:16
Well, I think, again, it's difficult to set a rule. But if, for example, you're working in the field of knee replacements and your own company's knee replacement is being considered, you would definitely not be able to be part of it. But there would also be a little bit of a commercial conflict there, as well, so I don't think it would be considered suitable for you to be part of that discussion where any knee replacement was being considered.

And the Scheduling Committee, again, it's slightly different, when we have community pharmacists there to be able to give us advice on the effect of down scheduling a product so that it's now available in community pharmacies, they have to declare that conflict. But clearly, they've got that commercial interest or real-life experience to be able to advise us appropriately. It does depend on the industry, and it does depend on the sort of products that you're working with. 
But if, for example, you were working for one of the larger device companies that bring products to us all the time, we'd have to exclude you from conversation a lot, and also exclude you from conversation, where a competitor's product was coming through, so it would make it a bit murky.

But if you're working in a biotech that's working on a very small, specific brand of products, then your expertise in engineering, materials engineering, might be seen to be quite useful across the board.

SS Thank you. Very lucky last. Approximately how many products would a member be the first speaker or speaker on in each meeting?

00:57:04
AS   I'll do it for medical devices. Probably depending on your speciality. The cardiac people get a lot of items, but probably once every three meetings, you'd be the presenter, would be a rule of thumb. You're not going to do three each meeting, and you're probably not even going to do one a meeting. Once every three meetings, sort of.

RL   And for medicines, I think it's not more than one per meeting. And from memory, oncology and immunology tends to get a bit of a busy run, but you would only be given one per meeting. And if there was a second one, then you might be asked to do as a second speaker, or even a third. And we're often pulling in advisors from the general community, as well, to help support that role within the committee, so you certainly wouldn't be overburdened with more than one per meeting.

SS    Great. Thank you. Well, that's the end of the questions that came through. For anyone who has questions following the meeting, or once they've had a look at a look through the documentation, please send us an email. The information is up on the screen now. And I'm going to hand back to the TGA webinar team to close us out. Thank you.

H  Thank you so much, Sarah, Robyn, Anne and Jo. As you can see on the slides here, don't forget to check out our social media pages for the TGA. The links are on the chat. Also, send us any further questions or any comments you have to the email addresses provided on the chat, as well. Otherwise, I hope you all have a great evening and see you next time. Bye. Thank you. 
00:58:58