Join the network: stories of the experts shaping the European Pharmacopoeia

Description

Have you ever stopped to think that there is a story behind every medicinal product you pick up at the pharmacy? In fact, there are thousands of stories, thousands of people – experts – who have devoted countless weeks, months and even years to ensure that the medicines you take are safe and effective.

The European Pharmacopoeia (Ph. Eur.), which sets the quality standards for medicines in Europe, is the product of scientific rigour, dedicated exchange, passion and consensus among a vast network of scientific experts from all over the world who contribute their valuable expertise – whether in biologicals, herbal medicines, chemical analyses, or other pharmaceutical fields.

In this podcast episode, you will hear from two of our experts: Gisela Fontaine, an analytical chemist from Switzerland; and Edward Bush, a scientist and pharmacopoeia specialist who joined the Ph. Eur. expert network more than 10 years ago.

Join Sarah-Taïssir Bencharif – physician, health reporter and the host of #EDQMOnAir – as she explores their stories; from why they got involved and what they’ve learned, to why this work matters so much, not just for their careers but for patients all over the world.

Are you an expert and want to learn more about the Network? Visit our dedicated Join the Network! page.

Hosted on Ausha. See ausha.co/privacy-policy for more information.

Transcription

Speaker #0
Hello and welcome to EDQM On Air, a podcast on public health brought to you by the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe. I'm Sara Teysir Ben-Sherif and I'm delighted to be joining you as the new host of the podcast. EDQM On Air is all about exploring the world of medicines and healthcare. It's a show where we talk about the science, collaboration, and people behind the standards that help protect public health across Europe and beyond. Today, we're focusing on something that sits right at the heart of that mission. Expertise. The European Pharmacopeia is often described as the gold standard for the quality of medicines. But behind every one of its quality standards is a whole network of scientists, regulators, and professionals from all around the world who come together to share their expertise to ensure medicines are safe, effective and of the highest quality. Because when it comes to medicines, expertise isn't just valuable, it's essential. And that's exactly why the European Pharmacopeia depends on its network of experts and why it's looking for new ones to join, including as part of its Call for Experts campaign. So in this episode, we're going to take you behind the scenes of that network. You'll hear directly from two current experts. Edward Bush is based in the UK and Guy de La Fontaine is in Switzerland. I spoke with each of them separately about how they got involved with the EDQM, what they've learned, and why this work matters so much, not just for their careers, but for patients everywhere. With that said, let's dive right in. Welcome, Edward. So before we get into the details, could you tell us a bit about who you are, what your role is, And what first brought you into European pharmacopeia work?
Speaker #1
So I'm a principal scientist and pharmacopeia specialist at AstraZeneca, based at our Macclesfield site just outside of Manchester, where I've worked for 30 years. And just a quick disclaimer, I'm speaking in a personal capacity. My views are not on behalf of the company where I work, AstraZeneca. So over 10 years ago, in a previous role as team manager, I became involved with Globe. with various global pharmacopoeias, particularly in the development of subsequent adoption of monographs for our products, which is an essential part of the product lifecycle. Today, I'm a long-serving member of expert working group MB, where I help develop monographs for multi-source products and modernize existing drug substance standards. So I'd be happy to share a little more about my journey to this role with you today.
Speaker #0
And welcome to you as well, Gisela. And let's also start at the beginning for you. So who are you? What do you do? And what was your first connection with the European Pharmacopeia and the EDQM network?
Speaker #2
I am an analytical chemist. I lead an elemental analysis lab now for the last 14 years in different positions. And my first chance to get in contact with EDQM was already during my studies in my preferred course called analytical strategy. We had a presentation from a representative of the pharmaceutical industry as a chemistry student. And he told us something about pharmacopeia, which was a word I never heard before. And he showed a book and he said, it's all very strict. And I was very confused. But later on, when I then wanted to start the industry, my first day there, actually during my application, I went into the lab. I was a trained ICP-MS analyst. I dealed into quantification of elemental impurities at very low levels, element specific. And then I went to this lab and a guy told me, ah, here we do heavy metals testing. He showed me two solutions, one a bit darker than the other. Yes, there's no elemental impurities. And I thought, what? This cannot be. How can you do that? But then I actually took this job and we did this test for years. But meanwhile, I'm more involved with actually quantifying those elemental impurities.
Speaker #0
Ed and Gisela were drawn to the EDQM for different reasons. And as you'll hear, they each had a moment that made them think, yes, this is something that I want to be a part of.
Speaker #1
So what first drew me to the EDQM network of experts was seeing it through a colleague's experience. So I had been providing input to a colleague who was already a member. and he gave me clear insight into how the group operates. how decisions are made, how the work programme is shaped, and how experts collaborate across disciplines. He was consistently positive and enthusiastic about the group, genuinely looking forward to the meetings and to working with other members. And that energy and sense of purpose were compelling. Today, I really understand that. And it made me want to be part of that community and to contribute in more direct ways, which is what ultimately motivated me to take on this role.
Speaker #2
Actually, it wasn't directly coming from me, but my company was actively searching for experts to join the network to be able to influence what we're dealing with. So then I started to process. I got myself informed on how this works. And I found, wow, there's an ICP group. There's a heavy metals group. There's inorganic materials. This is so interesting. And since then, I'm actually hooked. And I've meanwhile also joined the general methods group, which incorporate ICP. and heavy metals. And it really has broadened my horizon on what the EDQM is dealing with.
Speaker #0
And just for our audience, can you tell us what ICP stands for and means?
Speaker #2
ICP is inductively coupled plasma. And you can then add a detector, an MS, a mass spectrometer, or an OES to detect low levels or higher levels of elements.
Speaker #0
Okay, so it's a technique.
Speaker #2
Yeah, it's a very sensitive technique to determine elements.
Speaker #0
As we heard, Erin Giesela's work is highly technical. And so I wanted to better understand what contributing to the European Pharmacopeia looks like on a day-to-day basis.
Speaker #2
Actually, the work starts before you go to the Pharmacopeia because you need to prepare. So we have, in most groups, I think it's twice yearly a meeting where you get a lot of input before questions from all around Europe or across the world. to certain monographs or requests to update something and then this is uploaded you read the all the documents you prepare probably your own input and then you either take play go to strasbourg or you can participate online and discuss the topics which you're going through some if you are an expert for some years you know your topics because it's not a one time thing. This is all going long-term. So you get a request, you decide, does this need more work? Does this only need an explanation? And if there's more work to be done, then it's decided who can do that and need a collaboration for this, or can you do this on your own?
Speaker #1
So day-to-day contributes into the European Pharmacopoeia as a member of expert working group 10B. It means reviewing data, drafting and revising monographs. working with peers from industry, authorities, academia and EDQM to turn scientific best practice into clear and forcible standards. In the group, we discuss analytical methods, specifications, system suitability and validation, limits and acceptance criteria, and the practicalities of implementation across diverse labs. We balance science, regulatory expectations, environmental impact. resolve stakeholder comments and agree updates or new texts that reduce variability and support reliability and quality control. So medicines are consistently safe and effective for patients. So it's a very rewarding experience to contribute in this manner.
Speaker #0
Can you share with us a particular project that highlights how the work you do helps protect patients and public health?
Speaker #1
Yeah, so we develop and modernize legally enforceable monographs. and these patient-centric standards that make quality control reliable, reduce inter-lab variability, and keep medicine supply continuous for patients. Within Group 10B, I helped deliver our group's first finished product monograph in the European Pharmacopeia. So from pilot to adoption as an official public standard. And we delivered this through close teamwork and stakeholder engagement. We overcame scientific... and implementation challenges to produce a clear and modern fit-for-purpose requirement. So this standard now supports consistent quality control and helps maintain a continuous supply of high-quality medicines to patients.
Speaker #0
I asked Gisela the same question, to understand how her work also translates from the lab into helping protect patients and public health.
Speaker #2
My expertise, of course, is elemental impurities. That was large. There's a test for it, this visual limit test for last 100 years, but it's not very sensitive. So it has been replaced in a joint effort from... the US, from Europe and also Japan to get the specific measurements. And those limits in the beginning were all different for the different pharmacopoeias, which was a mess for everyone having to handle this. But it was also needed for new players on the market to come in there that this is really controlled. at a specific level for a specific element because the heavy metal limit test as a visual test wasn't very selective or not and also not sensitive. So sometimes we had a solution which was fine for the visual test, but when we measured it with a different technique, they were actually well above the limits. So introducing this test was really improving that. And then the alignment now, that was my greatest. expertise actually with the edqm so far that we had a meeting to align the pharmacopoeias across the world mainly was the usp the european pharmacopoeia the japanese one and the indian one to align on how we want to have this formulated and there were people there which i knew were in the beginning of this new chapter and they were participating and i could talk to them that was really awe-inspiring for me and then i had to present something or i had to explain why we want to have a validation parameter included in which was, in our opinion, was equivalent the precision measurements to what was already in the USP. And we really had to convince them to also accept how the European pharmacopoeia accepted it for the last years. I was so nervous.
Speaker #0
I can only imagine.
Speaker #2
But I think that really helped because now all the validation data acquired, according to the European pharmacopoeia monograph, is still valid. So. with the update, with the alignment, the harmonization, and doesn't need to be repeated, which would not improve quality in my opinion. But with a test in place, makes sure that the pharma products on the market have a low level of elemental impurities and are safe.
Speaker #0
So am I understanding it correctly that essentially you work to harmonize the standard, like the level of these impurities between the European pharmacopeia, the US pharmacopeia, the India's pharmacopeia, so kind of globally trying to harmonize it so that all medications have the same standard of safety of, you know, this is the highest level of these impurities that we can tolerate in our medicines. Is that correct?
Speaker #2
That is correct. Now it goes more about how you analyze this. The ICH has already defined now limits, which was helpful, and all pharmacopoeias can follow the ICH, but the actual way how to do that. It's defined in a specific pharmacophagia. And this is now in the process of becoming a land. I think the last one will be published next April.
Speaker #0
So it's not just about the levels, but it's about how we measure those levels to make sure that we're measuring them in a way that's consistent and harmonized and, you know, reproducible across different pharmacopoeia jurisdictions. Is that correct?
Speaker #2
That is correct.
Speaker #0
Okay. That's very cool. As I spoke with Ed and Gisela, their passion for their work was palpable. So I wanted to know more about what they each gained from being part of this intricate global network.
Speaker #1
OK, so it comes as no surprise that many experts mention the network is rewarding professionally and also personally. So for myself, I've gained a strong cross-industry network, deeper insights into compendial science and regulator expectations, and practical experience implementing changes. So collaboration across CDQM, authorities, academics. an industry that sharpened my technical leadership and negotiation skills. And it's led to new roles for me and enabled greener, pragmatic testing solutions to be developed within the European Pharmacopeia. So personally, it's been so rewarding. I've built trusted relationships and friendships from across the group that help make consensus and problem solving faster. So again, it's been a great experience and I solely recommend it to others.
Speaker #2
chance to get in contact with many very different experts which are all very interested and curious and like to work with each other and like to be precise because if you put out a document for all to follow you really need to be precise in what you request from all the users and so I'm like this as well So it's really nice to talk to other people who have the same mindset and don't mind actually talking about, is this formulation correct? Or do we need to put it a bit differently for users to better understand and to make it clear? People on a personal level, they're also usually very interesting. And it's really nice to exchange across Europe. Since I live in Switzerland, although I'm originally German, but it's really a great chance for Switzerland to engage in something which is very European and brings all the European nations together to see how hard it is to bring all of those together. It needs work, but it's also worthwhile.
Speaker #0
Absolutely. Finding consensus is never easy, but it's pretty well worth the effort. What's been one of the most fun or unexpected or surprising things of being part of this community for you?
Speaker #1
OK, I can answer that. On a lighter note, then, the community's traditions are really special. Our group, 10B, is longstanding. January 2026 will mark the group's 150th meeting. We meet in Strasbourg and over the years, the Strasbourg... evening after our January meeting has become a Christmas celebration. So in the spirit of collaboration, experts bring food and drink from their homes from across Europe to share. As a UK representative, I haven't brought fish and chips, but over the years I've brought Christmas pudding, beer, and most recently a traditional Bakewell pudding, which was very well received. So it's a special evening that builds camaraderie, strengthens networks, and reinforces the collaborative spirit. that makes our group so special and unique.
Speaker #0
That sounds really fun and delicious. Thank you very much for sharing that with us.
Speaker #2
One thing which surprised me in a meeting with the General Methods group was I realized, okay, the Swiss delegation is the largest for such a small country. That was surprising to me, but it's not like this in all the other groups. And something else that was just curious, sometimes if you... I have an on-site meeting in Strasbourg. The experts meet on the day before. Since I live in Basel, I don't sleep. I have a sleepover in Strasbourg, but I go there by train. And once I could manage to go to the dinner the night before, but I came there alone from the train station and I walked through the city. And at some point, music began blaring and five Spidermans ran towards me.
Speaker #0
Oh, dear.
Speaker #2
I was very surprised. But then a whole jogging group came along. It was like a party.
Speaker #0
Those were the adventures before the meeting. I love that.
Speaker #2
Well, that was very surprising.
Speaker #0
Wow. It sounds like being part of this group is a lot of fun and it's also very rewarding professionally.
Speaker #2
Yes, it is very rewarding. You get to know people from all over Europe. You have one from Spain, from Sweden, from England, from sometimes even from China, from France, from Germany. It's really a diverse group. industry, from university, from the agency labs, that is really a very interesting mix of people.
Speaker #0
It sounds like it's definitely a network that is a lot of fun and rewarding. As you know, the EDQM is looking to expand its network of experts. So we'd love to hear from you about some tips and tricks on the role and what would make someone a good fit for it. Let's say you were chatting with a scientist or a professional who's undecided about applying. What would you tell them?
Speaker #1
I really stress I would really strongly consider apply. So tell them it's a rare opportunity to translate scientific best practice into public standards that directly protect medicine quality and patient safety across Europe and beyond. So you'll gain deep insight into cross-industry challenges, regulator expectations. expectations and compendial science, also learning how to build consensus and deliver standards, so the monographs, that balance scientific rigor, practical implementation and environmental impact. And also it's accelerated my growth personally. So it's strengthened my technical leadership, influencing and negotiation skills. Over time, I've been appointed to similar roles with the British Pharmacopeia. I've joined a cross-industry advocacy group. The Midwest Compendial Discussion Group, where I also work closely with the United States Pharmacopeia, and have been promoted into a dedicated pharmacopeial role within my company.
Speaker #0
And Gisela, what would you say to encourage someone who's on the fence about applying? And what qualities or mindset do you think would make someone well-suited to become an EDQM expert?
Speaker #2
What are your goals to join there? What do you like to do? You need to be... ready to engage sometimes in things which are not only your expertise, but also from others. If you're curious, that is really mind opening and can. give you a lot of benefit. You need some time because to read all the documents, you just need time to go through it step by step. You need thoroughness and curiosity and a bit of resilience and readiness to engage in this for a longer period of time because you need to get agreement from all and then to work on comments from... a very large range of people. So this process is there for the long run, which makes it fulfilling, but it's not an immediate reward.
Speaker #0
And in your view, what qualities or mindsets would make someone a really good fit to be a European Pharmacopeia expert?
Speaker #1
Great European Pharmacopeia expert has a patient-focused mindset with scientific rigor. and pragmatism. So designing methods and limits that are robust, implementable, and sustainable across diverse settings. So in delivering this, they will listen, build consensus across industry, authorities, and EDQM, think end-to-end about supply and control, and act with integrity, accountability, and continuous curiosity.
Speaker #2
Nearly the same range of characteristics you need. curiosity you need expertise in what you do the readiness to also find a common solution which might not be your preferred one but one which works for all you need to have a mindset that you want to do things in the long run and think ahead and into the future and A bit of resilience and curiosity in people and topics.
Speaker #0
Sounds like curiosity is definitely a leading theme here. Once someone joins the network, how can they make the most of their experience? And what helped you get the most out of yours? Because you certainly sound like you're absolutely loving it.
Speaker #2
Yes, I actually do like it a lot. You need to like to travel. I would definitely try to. Also go to Strasbourg at least once a year because meeting in person is always different from only meeting online. Of course, if you come from China across the world, this might not be possible every year. But that is really very fulfilling to also talk to people then across the table about their experiences on their workplace.
Speaker #0
And Strasbourg is the city of the Spider-Man incident. Lots of good memories to come there.
Speaker #2
And it's the heart of Europe. You feel the ADQM building is directly next to the Palace of Europe, which was for me, wow, I'm actually here. So that helps. And if you have a specific interest, try to join into a group which is related to that. And if you're curious, also engage with other people. helps you then get into different areas of expertise, because the range of areas that ADQM works on is very broad.
Speaker #1
So reflecting back, so keep asking why and get involved. Start drafting a monograph, take on work packages, respond to consultations and build relationships across the members within your group. So from industry, authorities and ADQM. but push for practical, robust solutions that protect supply and patient safety. I guess what helped me most was tackling complex monograph development, including the finished product monograph pilot I mentioned earlier, speaking up, building consensus and taking learnings back into my company.
Speaker #0
Thank you so much for your time and for sharing your experiences with us. We really appreciate it.
Speaker #1
Thank you, Sarah. It's been a pleasure. Thank you.
Speaker #2
You're welcome. Thank you for the opportunity.
Speaker #0
After speaking with Ed and Gisela, it's clear that the European Pharmacopoeia is more than just a collection of technical texts. It's a dynamic network of experts who work together across countries and across disciplines to protect public health and ensure the quality of medicines. If you've been inspired by today's episode and you're wondering how to join in on the fun, check out the edqm.eu website for more information on how to apply. That's it for this episode. A big thanks to our guests, to the production team, and to each of you for tuning in. If you enjoyed this episode, please subscribe to our show on your podcast platform of choice to make sure you don't miss out on new releases. And we'd love to hear from you, so feel free to reach us on X, LinkedIn, or Facebook. This has been EDQM On Air. I'm Sara Tseysir Ben-Sherif. Thanks for listening, and until next time.

Description

Are you an expert and want to learn more about the Network? Visit our dedicated Join the Network! page.

Hosted on Ausha. See ausha.co/privacy-policy for more information.

Transcription

Speaker #0
Hello and welcome to EDQM On Air, a podcast on public health brought to you by the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe. I'm Sara Teysir Ben-Sherif and I'm delighted to be joining you as the new host of the podcast. EDQM On Air is all about exploring the world of medicines and healthcare. It's a show where we talk about the science, collaboration, and people behind the standards that help protect public health across Europe and beyond. Today, we're focusing on something that sits right at the heart of that mission. Expertise. The European Pharmacopeia is often described as the gold standard for the quality of medicines. But behind every one of its quality standards is a whole network of scientists, regulators, and professionals from all around the world who come together to share their expertise to ensure medicines are safe, effective and of the highest quality. Because when it comes to medicines, expertise isn't just valuable, it's essential. And that's exactly why the European Pharmacopeia depends on its network of experts and why it's looking for new ones to join, including as part of its Call for Experts campaign. So in this episode, we're going to take you behind the scenes of that network. You'll hear directly from two current experts. Edward Bush is based in the UK and Guy de La Fontaine is in Switzerland. I spoke with each of them separately about how they got involved with the EDQM, what they've learned, and why this work matters so much, not just for their careers, but for patients everywhere. With that said, let's dive right in. Welcome, Edward. So before we get into the details, could you tell us a bit about who you are, what your role is, And what first brought you into European pharmacopeia work?
Speaker #1
So I'm a principal scientist and pharmacopeia specialist at AstraZeneca, based at our Macclesfield site just outside of Manchester, where I've worked for 30 years. And just a quick disclaimer, I'm speaking in a personal capacity. My views are not on behalf of the company where I work, AstraZeneca. So over 10 years ago, in a previous role as team manager, I became involved with Globe. with various global pharmacopoeias, particularly in the development of subsequent adoption of monographs for our products, which is an essential part of the product lifecycle. Today, I'm a long-serving member of expert working group MB, where I help develop monographs for multi-source products and modernize existing drug substance standards. So I'd be happy to share a little more about my journey to this role with you today.
Speaker #0
And welcome to you as well, Gisela. And let's also start at the beginning for you. So who are you? What do you do? And what was your first connection with the European Pharmacopeia and the EDQM network?
Speaker #2
I am an analytical chemist. I lead an elemental analysis lab now for the last 14 years in different positions. And my first chance to get in contact with EDQM was already during my studies in my preferred course called analytical strategy. We had a presentation from a representative of the pharmaceutical industry as a chemistry student. And he told us something about pharmacopeia, which was a word I never heard before. And he showed a book and he said, it's all very strict. And I was very confused. But later on, when I then wanted to start the industry, my first day there, actually during my application, I went into the lab. I was a trained ICP-MS analyst. I dealed into quantification of elemental impurities at very low levels, element specific. And then I went to this lab and a guy told me, ah, here we do heavy metals testing. He showed me two solutions, one a bit darker than the other. Yes, there's no elemental impurities. And I thought, what? This cannot be. How can you do that? But then I actually took this job and we did this test for years. But meanwhile, I'm more involved with actually quantifying those elemental impurities.
Speaker #0
Ed and Gisela were drawn to the EDQM for different reasons. And as you'll hear, they each had a moment that made them think, yes, this is something that I want to be a part of.
Speaker #1
So what first drew me to the EDQM network of experts was seeing it through a colleague's experience. So I had been providing input to a colleague who was already a member. and he gave me clear insight into how the group operates. how decisions are made, how the work programme is shaped, and how experts collaborate across disciplines. He was consistently positive and enthusiastic about the group, genuinely looking forward to the meetings and to working with other members. And that energy and sense of purpose were compelling. Today, I really understand that. And it made me want to be part of that community and to contribute in more direct ways, which is what ultimately motivated me to take on this role.
Speaker #2
Actually, it wasn't directly coming from me, but my company was actively searching for experts to join the network to be able to influence what we're dealing with. So then I started to process. I got myself informed on how this works. And I found, wow, there's an ICP group. There's a heavy metals group. There's inorganic materials. This is so interesting. And since then, I'm actually hooked. And I've meanwhile also joined the general methods group, which incorporate ICP. and heavy metals. And it really has broadened my horizon on what the EDQM is dealing with.
Speaker #0
And just for our audience, can you tell us what ICP stands for and means?
Speaker #2
ICP is inductively coupled plasma. And you can then add a detector, an MS, a mass spectrometer, or an OES to detect low levels or higher levels of elements.
Speaker #0
Okay, so it's a technique.
Speaker #2
Yeah, it's a very sensitive technique to determine elements.
Speaker #0
As we heard, Erin Giesela's work is highly technical. And so I wanted to better understand what contributing to the European Pharmacopeia looks like on a day-to-day basis.
Speaker #2
Actually, the work starts before you go to the Pharmacopeia because you need to prepare. So we have, in most groups, I think it's twice yearly a meeting where you get a lot of input before questions from all around Europe or across the world. to certain monographs or requests to update something and then this is uploaded you read the all the documents you prepare probably your own input and then you either take play go to strasbourg or you can participate online and discuss the topics which you're going through some if you are an expert for some years you know your topics because it's not a one time thing. This is all going long-term. So you get a request, you decide, does this need more work? Does this only need an explanation? And if there's more work to be done, then it's decided who can do that and need a collaboration for this, or can you do this on your own?
Speaker #1
So day-to-day contributes into the European Pharmacopoeia as a member of expert working group 10B. It means reviewing data, drafting and revising monographs. working with peers from industry, authorities, academia and EDQM to turn scientific best practice into clear and forcible standards. In the group, we discuss analytical methods, specifications, system suitability and validation, limits and acceptance criteria, and the practicalities of implementation across diverse labs. We balance science, regulatory expectations, environmental impact. resolve stakeholder comments and agree updates or new texts that reduce variability and support reliability and quality control. So medicines are consistently safe and effective for patients. So it's a very rewarding experience to contribute in this manner.
Speaker #0
Can you share with us a particular project that highlights how the work you do helps protect patients and public health?
Speaker #1
Yeah, so we develop and modernize legally enforceable monographs. and these patient-centric standards that make quality control reliable, reduce inter-lab variability, and keep medicine supply continuous for patients. Within Group 10B, I helped deliver our group's first finished product monograph in the European Pharmacopeia. So from pilot to adoption as an official public standard. And we delivered this through close teamwork and stakeholder engagement. We overcame scientific... and implementation challenges to produce a clear and modern fit-for-purpose requirement. So this standard now supports consistent quality control and helps maintain a continuous supply of high-quality medicines to patients.
Speaker #0
I asked Gisela the same question, to understand how her work also translates from the lab into helping protect patients and public health.
Speaker #2
My expertise, of course, is elemental impurities. That was large. There's a test for it, this visual limit test for last 100 years, but it's not very sensitive. So it has been replaced in a joint effort from... the US, from Europe and also Japan to get the specific measurements. And those limits in the beginning were all different for the different pharmacopoeias, which was a mess for everyone having to handle this. But it was also needed for new players on the market to come in there that this is really controlled. at a specific level for a specific element because the heavy metal limit test as a visual test wasn't very selective or not and also not sensitive. So sometimes we had a solution which was fine for the visual test, but when we measured it with a different technique, they were actually well above the limits. So introducing this test was really improving that. And then the alignment now, that was my greatest. expertise actually with the edqm so far that we had a meeting to align the pharmacopoeias across the world mainly was the usp the european pharmacopoeia the japanese one and the indian one to align on how we want to have this formulated and there were people there which i knew were in the beginning of this new chapter and they were participating and i could talk to them that was really awe-inspiring for me and then i had to present something or i had to explain why we want to have a validation parameter included in which was, in our opinion, was equivalent the precision measurements to what was already in the USP. And we really had to convince them to also accept how the European pharmacopoeia accepted it for the last years. I was so nervous.
Speaker #0
I can only imagine.
Speaker #2
But I think that really helped because now all the validation data acquired, according to the European pharmacopoeia monograph, is still valid. So. with the update, with the alignment, the harmonization, and doesn't need to be repeated, which would not improve quality in my opinion. But with a test in place, makes sure that the pharma products on the market have a low level of elemental impurities and are safe.
Speaker #0
So am I understanding it correctly that essentially you work to harmonize the standard, like the level of these impurities between the European pharmacopeia, the US pharmacopeia, the India's pharmacopeia, so kind of globally trying to harmonize it so that all medications have the same standard of safety of, you know, this is the highest level of these impurities that we can tolerate in our medicines. Is that correct?
Speaker #2
That is correct. Now it goes more about how you analyze this. The ICH has already defined now limits, which was helpful, and all pharmacopoeias can follow the ICH, but the actual way how to do that. It's defined in a specific pharmacophagia. And this is now in the process of becoming a land. I think the last one will be published next April.
Speaker #0
So it's not just about the levels, but it's about how we measure those levels to make sure that we're measuring them in a way that's consistent and harmonized and, you know, reproducible across different pharmacopoeia jurisdictions. Is that correct?
Speaker #2
That is correct.
Speaker #0
Okay. That's very cool. As I spoke with Ed and Gisela, their passion for their work was palpable. So I wanted to know more about what they each gained from being part of this intricate global network.
Speaker #1
OK, so it comes as no surprise that many experts mention the network is rewarding professionally and also personally. So for myself, I've gained a strong cross-industry network, deeper insights into compendial science and regulator expectations, and practical experience implementing changes. So collaboration across CDQM, authorities, academics. an industry that sharpened my technical leadership and negotiation skills. And it's led to new roles for me and enabled greener, pragmatic testing solutions to be developed within the European Pharmacopeia. So personally, it's been so rewarding. I've built trusted relationships and friendships from across the group that help make consensus and problem solving faster. So again, it's been a great experience and I solely recommend it to others.
Speaker #2
chance to get in contact with many very different experts which are all very interested and curious and like to work with each other and like to be precise because if you put out a document for all to follow you really need to be precise in what you request from all the users and so I'm like this as well So it's really nice to talk to other people who have the same mindset and don't mind actually talking about, is this formulation correct? Or do we need to put it a bit differently for users to better understand and to make it clear? People on a personal level, they're also usually very interesting. And it's really nice to exchange across Europe. Since I live in Switzerland, although I'm originally German, but it's really a great chance for Switzerland to engage in something which is very European and brings all the European nations together to see how hard it is to bring all of those together. It needs work, but it's also worthwhile.
Speaker #0
Absolutely. Finding consensus is never easy, but it's pretty well worth the effort. What's been one of the most fun or unexpected or surprising things of being part of this community for you?
Speaker #1
OK, I can answer that. On a lighter note, then, the community's traditions are really special. Our group, 10B, is longstanding. January 2026 will mark the group's 150th meeting. We meet in Strasbourg and over the years, the Strasbourg... evening after our January meeting has become a Christmas celebration. So in the spirit of collaboration, experts bring food and drink from their homes from across Europe to share. As a UK representative, I haven't brought fish and chips, but over the years I've brought Christmas pudding, beer, and most recently a traditional Bakewell pudding, which was very well received. So it's a special evening that builds camaraderie, strengthens networks, and reinforces the collaborative spirit. that makes our group so special and unique.
Speaker #0
That sounds really fun and delicious. Thank you very much for sharing that with us.
Speaker #2
One thing which surprised me in a meeting with the General Methods group was I realized, okay, the Swiss delegation is the largest for such a small country. That was surprising to me, but it's not like this in all the other groups. And something else that was just curious, sometimes if you... I have an on-site meeting in Strasbourg. The experts meet on the day before. Since I live in Basel, I don't sleep. I have a sleepover in Strasbourg, but I go there by train. And once I could manage to go to the dinner the night before, but I came there alone from the train station and I walked through the city. And at some point, music began blaring and five Spidermans ran towards me.
Speaker #0
Oh, dear.
Speaker #2
I was very surprised. But then a whole jogging group came along. It was like a party.
Speaker #0
Those were the adventures before the meeting. I love that.
Speaker #2
Well, that was very surprising.
Speaker #0
Wow. It sounds like being part of this group is a lot of fun and it's also very rewarding professionally.
Speaker #2
Yes, it is very rewarding. You get to know people from all over Europe. You have one from Spain, from Sweden, from England, from sometimes even from China, from France, from Germany. It's really a diverse group. industry, from university, from the agency labs, that is really a very interesting mix of people.
Speaker #0
It sounds like it's definitely a network that is a lot of fun and rewarding. As you know, the EDQM is looking to expand its network of experts. So we'd love to hear from you about some tips and tricks on the role and what would make someone a good fit for it. Let's say you were chatting with a scientist or a professional who's undecided about applying. What would you tell them?
Speaker #1
I really stress I would really strongly consider apply. So tell them it's a rare opportunity to translate scientific best practice into public standards that directly protect medicine quality and patient safety across Europe and beyond. So you'll gain deep insight into cross-industry challenges, regulator expectations. expectations and compendial science, also learning how to build consensus and deliver standards, so the monographs, that balance scientific rigor, practical implementation and environmental impact. And also it's accelerated my growth personally. So it's strengthened my technical leadership, influencing and negotiation skills. Over time, I've been appointed to similar roles with the British Pharmacopeia. I've joined a cross-industry advocacy group. The Midwest Compendial Discussion Group, where I also work closely with the United States Pharmacopeia, and have been promoted into a dedicated pharmacopeial role within my company.
Speaker #0
And Gisela, what would you say to encourage someone who's on the fence about applying? And what qualities or mindset do you think would make someone well-suited to become an EDQM expert?
Speaker #2
What are your goals to join there? What do you like to do? You need to be... ready to engage sometimes in things which are not only your expertise, but also from others. If you're curious, that is really mind opening and can. give you a lot of benefit. You need some time because to read all the documents, you just need time to go through it step by step. You need thoroughness and curiosity and a bit of resilience and readiness to engage in this for a longer period of time because you need to get agreement from all and then to work on comments from... a very large range of people. So this process is there for the long run, which makes it fulfilling, but it's not an immediate reward.
Speaker #0
And in your view, what qualities or mindsets would make someone a really good fit to be a European Pharmacopeia expert?
Speaker #1
Great European Pharmacopeia expert has a patient-focused mindset with scientific rigor. and pragmatism. So designing methods and limits that are robust, implementable, and sustainable across diverse settings. So in delivering this, they will listen, build consensus across industry, authorities, and EDQM, think end-to-end about supply and control, and act with integrity, accountability, and continuous curiosity.
Speaker #2
Nearly the same range of characteristics you need. curiosity you need expertise in what you do the readiness to also find a common solution which might not be your preferred one but one which works for all you need to have a mindset that you want to do things in the long run and think ahead and into the future and A bit of resilience and curiosity in people and topics.
Speaker #0
Sounds like curiosity is definitely a leading theme here. Once someone joins the network, how can they make the most of their experience? And what helped you get the most out of yours? Because you certainly sound like you're absolutely loving it.
Speaker #2
Yes, I actually do like it a lot. You need to like to travel. I would definitely try to. Also go to Strasbourg at least once a year because meeting in person is always different from only meeting online. Of course, if you come from China across the world, this might not be possible every year. But that is really very fulfilling to also talk to people then across the table about their experiences on their workplace.
Speaker #0
And Strasbourg is the city of the Spider-Man incident. Lots of good memories to come there.
Speaker #2
And it's the heart of Europe. You feel the ADQM building is directly next to the Palace of Europe, which was for me, wow, I'm actually here. So that helps. And if you have a specific interest, try to join into a group which is related to that. And if you're curious, also engage with other people. helps you then get into different areas of expertise, because the range of areas that ADQM works on is very broad.
Speaker #1
So reflecting back, so keep asking why and get involved. Start drafting a monograph, take on work packages, respond to consultations and build relationships across the members within your group. So from industry, authorities and ADQM. but push for practical, robust solutions that protect supply and patient safety. I guess what helped me most was tackling complex monograph development, including the finished product monograph pilot I mentioned earlier, speaking up, building consensus and taking learnings back into my company.
Speaker #0
Thank you so much for your time and for sharing your experiences with us. We really appreciate it.
Speaker #1
Thank you, Sarah. It's been a pleasure. Thank you.
Speaker #2
You're welcome. Thank you for the opportunity.
Speaker #0
After speaking with Ed and Gisela, it's clear that the European Pharmacopoeia is more than just a collection of technical texts. It's a dynamic network of experts who work together across countries and across disciplines to protect public health and ensure the quality of medicines. If you've been inspired by today's episode and you're wondering how to join in on the fun, check out the edqm.eu website for more information on how to apply. That's it for this episode. A big thanks to our guests, to the production team, and to each of you for tuning in. If you enjoyed this episode, please subscribe to our show on your podcast platform of choice to make sure you don't miss out on new releases. And we'd love to hear from you, so feel free to reach us on X, LinkedIn, or Facebook. This has been EDQM On Air. I'm Sara Tseysir Ben-Sherif. Thanks for listening, and until next time.

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