 on quantities of advocacy and quality medicines and beyond. Please stay with us for the next 90 minutes. It will be hopefully very interactive as well with lots of questions that we will ask you during this presentation. And if the time permits at the end, we'll have a Q&A to discuss certain questions that have been coming in throughout the webinar. So please feel free to use the chat box for all questions that you have. Again, this is one of many turning up webinars in the future. We have Benoit Riem, who is my colleague. Benoit Riem presenting this webinar today. My name is Alex Fichter and I'm moderating kind of helping Benoit in the background. We also have Christian Sein, our scientific affairs colleague at the EMEA office, who is our host and is also technically supporting this webinar. The three of us will hopefully provide you lots of insights of USP. And I'm really glad that Benoit as our Senior Strategic Customer Development Manager who has regional responsibility within EMEA is hosting this very first webinar for you. So while we are going into the next session of this practice webinar, I would like to present you with the first polling, which are three questions for you that you have a couple minutes to respond to. Please feel free to provide us with your responses. They're all anonymous and really helpful for us to get an understanding of how much you already know from us. And maybe during the webinar in which direction we should go in order to give you the insights and background that you need to have a full understanding. So the first question that I would like you to answer is, is USP part of the US government through or false? And the second question will be, is USP in charge of quality only and not safety and efficacy through or false? And the third question, medicines are required to comply to USP standards through or false? We'll give you a couple more minutes to respond. And before we go over to the webinar, we will quickly address these three questions with the correct answers so that you already have them aside. Yeah, so maybe already a little bit of comments to the polls that I'm seeing coming in here. The participants are really participating very nicely. We have already almost 60% of the polls finished by the participants. There are still 10 in progress. And a third did not start yet, but now it's going rapidly. We only have 25 that did not start so far and we are now at 60% of finished polls. So I would give it maybe another 30 seconds to one minute before we close the poll and would give you then also quickly the anonymous results of that poll as a start before Benoit is going to go on his presentation. Sounds good. So I think we can close the poll now. We have 70% of the participants finished the survey. So you have a couple of seconds more when I push the close button here. But then the poll will be closed. So it's 15 seconds still that you have to finish the poll. You know, 10, 5, 4, 3, 2, 1. Now the question is closed and I would apply here so that you can see it. And Alex, you might want to comment. Sure. The first question is USB part of the US government. We're actually not. We are a private non-for-profit organization. We're self-funded and I don't want to steal the thunder from Benoit's presentation. I'm sure he's going to go into more detail of this aspect. Is USB in charge of quality only or also safety and efficacy? Yes, we are in charge for quality only. Safety and efficacy is solely FDA's responsibility. Third question, medicines are required to comply to USP standards. That's true in the case of the USB or the USA regulatory aspect. And this is part of the Food, Drug and Cosmetic Act since 1938. That medicines have to comply to USP standards when marketed in the States. In other countries, this may be true or not, but you need to refer to your local regulator whether or not they are recognizing or even endorsing USB standards. So again, Benoit is going to go into more details. And now I'm really happy to hand it over to Benoit and have fun. Get most out of the presentation today. Let us know during the presentation and after during the Q&A session if there is more you would want to know from us. Thank you, Benoit. Thank you very much, Alex. Good morning, good afternoon, or even good evening. I'm welcoming you in different ways as the attendance to this webinar is truly global. You're joining us from all the continents. I may have welcomed you in different languages as well, but my skills are too limited for that. Thank you for being here today. I hope you will enjoy your time. I'm Benoit Rimm, strategic customer development manager from USP Europe, Middle East and African office that is located in Basel, Switzerland. Considering the difficulties to travel nowadays, we decided to innovate when it comes to reaching out to our customers. This is why we have decided to conduct several webinars throughout this year. Each webinar will cover a specific topic such as USP reference standards, USPNF and how to navigate online, performance verification testing, it's about the solution, impurities and so on. The first webinar today aims to cover current topics, 200 years anniversary of USP, the 2020 convention and USP's response to COVID-19 pandemic. So it is my real pleasure to welcome you today for this webinar called 200 years of advocacy on quality medicines and beyond. Before talking about current topics, I will talk about USP's long, long tradition of helping establish the quality and safety of medicine. This first slide is about why USP was founded. Before USP was founded, the practice of medicine in the US was very chaotic. There were no uniform standards for quality. Medicines could often be far more dangerous than the cures they were supposed to provide. So in 1820, 11 physicians took action to protect patients from poor quality medicine. They founded the first pharmacopoeia of the United States. Today, USP is used in more than 150 countries. This painting on the screen is of the old Sennate chamber at the US Capitol. Those doctors met on January 1st, 1820 to establish the US Pharmacopoeial Convention. This would become today's USP. Simon Spaulding, Samuel Mitchell and Jacob Bidgelow were the founders of USP. Spaulding was an innovator in medicine and health. He was the first to initiate the use of cowpox to vaccinate against smallpox in the US. He was also responsible for the planning and work that resulted in the first pharmacopoeia of the United States. Mitchell has been the first president of the USP Convention. He served in both houses of the US Congress. He was an ardent advocate for the pharmacopoeia and wanted it to reflect America's national character and independence from Europe. Bidgelow was an expert in botany. He taught at Harvard University and became the primary author of the pharmacopoeia. He was responsible for establishing a single name for each drug. Even 200 years ago, these men recognized the vital importance of standards. They actively advocate for them. They helped building the capabilities of others to use them. We are proud to continue that work today. Building trust in the world's medicine, dietary supplements and foods through the standards we set. USP's founders published the first pharmacopoeia of the United States in December 1820. This first USP was a national set of uniform guidelines for medicine quality. Founders selected the best understood medicinal substances and preparations of the day. They defined as well the terminology, physicians and pharmacists would use to communicate about them and understand each other. Since then, the US Pharmacopoeia with the National Pharminary has become the essential companion on drug quality worldwide. And 200 years later, they are available online. In this slide is a text from the preface of the 1820 US Pharmacopoeia. It is the subject of a pharmacopoeia to select from among substances which possess medicinal power. Those, the utility of which is most fully established and best understood. The USP with the US Congress and other stakeholders has a long tradition of helping establish the quality and safety of medicine, supplements and foods as well. USP was first recognized in the Drug Importation Act of 1848. The Act aims to stop the flow of poor quality and ineffective drugs that were coming in from Europe. The Act required important medicines to meet the standard for strength and purity as established in the USP. In 1906, the Pure Food and Drug Act was enacted to fight deteriorated and mislabeled food and medicines. The Food and Drug Administration FDA was then founded. The Act also recognized the US Pharmacopoeia and the National Pharminary as official companion under federal law. In the mid-30s, more than 100 people died poisoned by an antibiotic liquid Chilfanila Med. This product had not been tested for toxicity. Congress responded with the Food Drug and Cosmetic Act in 1938. Companies have now to submit the data to the FDA before marketing. This legislation requires company to set new drugs to verify the USP standards for identity, strength, quality and purity. Congress also recognized USP requirements for packaging and labeling. It forbade the unilateral amending of or supplementation of USP prescribed tests or methods of assay. These are early examples. FDA-USP collaboration continues today as it is essential to ensure appropriate quality standards. This collaboration also ensures that USP standards reflect quality of FDA approved product. USP is a vital resource when tragedy strikes. USP, with its expert knowledge and quality standards, has a tradition of helping protect lives when crisis surface. This is done in partnership with the FDA and other stakeholders. In 1903, many children died because they had contracted tetanus from contaminated vaccine. USP introduced a public standard for diphtheria antitoxin to safeguard its manufacture. This was the first ever biologic product emitted into the US helicopter. Between 92 and 2007, in many countries, Panama, China, Haiti, Bangladesh, Argentina, Nigeria, India, there were mass poisonings. Toxic diethylene glycol was used instead of the more expensive non-toxic glycerin in cough, syrups, and other medicines. At the request of the FDA, USP further revised the USP monograph for glycerin. At the same time, FDA issued guidance on the testing of glycerin for the diethylene glycol. Even closer from now, in 2007-8, 2007 and 2008, the blood thinner heparin was deliberately tainted with a toxic substance. It caused the death of nearly 150 people and injured hundreds more. FDA asked USP to change the heparin standards to include testing techniques so that the added substance could be detected. Since then, USP has revised the heparin standard to include other impurities. USP also further refined testing methods. Even closer, in 2008, melamine was deliberately added to milk and baby formula, affecting an estimated 300,000 people. USP and others responded to the emergency with a toolbox of analytical solutions to address food alteration. Eventually, in 2012, there was a meningitis outbreak linked to compounded medicines. The US Congress enacted legislation to regulate the quality of compounded medicines. It clarified the FDA's authority over drugs compounding. It reaffirmed that a compounder must use bulk drug substances and ingredients that comply with USP standards. USP also has a long history of stepping up and moving quickly to ensure access to needed medicines. During World War II, there has been a very high demand for penicillin from wounded soldiers and civilians. USP and federal agencies worked together to develop penicillin standards. This was the response to the desperate need for the drug's mass production. The patent on insulin was set to expire in December 1941. There was no public standard available at that time. With the FDA and other stakeholders, USP developed a standard for insulin in less than one month. This ensured that patients would have access to the drug. These standards helped ensure the quality and consistency of these medicines, regardless of where they were manufactured. USP is an old organization, yet it has never been so young and dynamic. Our mission today remains the same, despite it was rewritten in modern language. This mission said, USP is a public standard setting organization. The compliance to USP's standards of medicines, food ingredients, or dietary supplements help ensure its quality, its safety, and its benefit. Therefore, we are proud to improve global health because our standards protect the patients. USP is our slogan, empowering a healthy tomorrow. A healthier world needs a strong foundation, one that established quality, sets the bar for scientific rigor and technological progress, and epitomize collaboration between industry, nonprofits, government, and academia. From the standards we create to the partnerships and conversations we foster, our scientists, advocates, and network of experts are critical to constructing and reinforcing this foundation to ensure people stay healthy, who we are, and where we were. As I said already, USP was founded in 1820. USP today is a non-profit, private, independent, and self-funded organization. All the revenues generated by the sales of the standards are used by USP to fulfill its public health mission. This organization is driven by values focused on quality standards to protect the public health. As we talked a little bit already in the pool at the beginning of this session, USP is internationally recognized and globally focused. The headquarters of USP is located in Rockville, Maryland. This is near Washington DC, near the NIH, the National Institute for Health, and FDA. Across the globe, USP has several laboratory facilities in US, of course, but also in India, China, Brazil, as well as in Ghana. We also have offices in Switzerland to cover the Europe, Middle East, and Africa, as well as in developing countries like Ethiopia, Indonesia, where we try to enhance the public health system. USP is a very large organization. Above 1,000 employees work at USP. This is the largest pharmacopia of the world. We also work with around 900 scientists, practitioners, and regulators. Those people are volunteers. They are experts. They help us to develop the standards that help protect the public health. So those volunteers are extremely important to USP. What is the relation between USP and FDA? As mentioned already, USP is a private not-for-profit organization. We established companional standards. We developed them. We revised them within collaboration with industry and other stakeholders. FDA is a government agency. So USP being private is definitely not part of FDA. FDA is in charge of enforcement of official texts, such as, of course, the GMPs, as well as the USPNF, as we talked already. And they are responsible for safety and efficacy. They grant market approval for drugs in the United States through NDA, ANDA, BLA, and so forth. Therefore, USP and the FDA collaborate together and FDA engagement goes beyond enforcing our standards. We work together to set those standards as well. Our impact. We estimate our impact of, we estimate our standards impact around 2 billion people globally. But that's a huge challenge and a huge responsibility on us. USP standards play a very important role by expanding access to medicines of good quality. Those standards are developed in collaboration with all stakeholders, government, industry, scientists from all around the world. Standards are even more important in the context of global supply chain. Standards are also used to combat counterfeit drugs. So standards matter. This slide is designed to explain why a patient may trust a drug. Both patients and practitioners assume that their drugs are safe, efficacious, and have the correct identity. They deliver the same performance as described in the label. They perform consistently over the shelf life. They are made in a manner that ensures quality and they are available when needed. USP plays a critical role in the trust a patient may have when taking a medicine. Adiltration is a legal term, meaning that product fails to meet the legal standards. In the Federal Food Drug and Cosmetic Act of 1938, as I mentioned already, one can read that a drug product in the US market must conform to the standards in USPNF to avoid possible charges of adulteration and misbranding. The supply chain of the component of a medicine became extremely complex during last decades. Our standards helped detect adulteration, especially during crisis times. Such standard medicine may contain no active ingredient, less than the required amount, or too much of the required amount. It may also contain ingredients not described on the package label. Quality can deteriorate in many settings. For example, during manufacturing, packaging, distribution, and storage. This is especially true in developing countries where supply chains are long and fragmented. Therefore, compliance with USP standards help assure that patients receive quality medicine. Falsified medicines are intentionally sold to unsuspecting patients for profit. Like substandard medicine, these may contain no active ingredients, less than the required amount, or of active ingredients, too much of the active ingredients, or even ingredients not described on the package label. In just one year, a projected 122,000 children under the age of five from 39 sub-Saharan African countries lost their lives as a result of counterfeit antimirals alone. USP works with local regulators around the world to develop the capacity to detect and remove falsified and substandard medicines from the market. We are also active in antimicrobial resistance. According to the review of antimicrobial resistance, roughly 700,000 people die each year due to drug resistance in illness, such as bacterial infections, malaria, HIV-AIDS, or tuberculosis. We know that substandard and falsified medicines can contribute to multi-drug resistant strains. Quality standards of pharmacopoeia around the world help ensure the identity, strength, quality, and purity of a medicine. They provide a measure to which to test, and those that reduce AMR antimicrobial resistance by helping keep sub-potent medicines out of the market. This objective can be further advanced by enhancing the capacity of regulatory authorities and manufacturers, especially in low- and middle-income countries. The goal there is to help ensure safe and beneficial medicines, including antibiotics, so that substandard and falsified products are detected. In 2020, this year, USP celebrates 200 years of building trust. As we talk about USP, we use forward trust, building trust in quality medicines, supplements, and food. Future, exploring trust in tomorrow's medical breakthrough. Science, protecting patients through science-based standards. Impact, improving the health of billion of people. These are the four pillars to frame our 200th anniversary story. USP launched several initiatives linked to this anniversary. The first one is Trust Our Consequences Report. USP joined MIT Center for Collective Intelligence and over 100 leaders in health and science. AIM was to anticipate the drivers of change and guide how we can be prepared to respond. The resulting report, named Trust Our Consequences to 2040, answers the question, What developments will shape people's health between now and 2040? Another question in this report is, How will trust be critical in making sure these developments help people everywhere live longer, better lives? This report will be published soon. The date of release is unknown at this point. The second initiative is Trust TV. Trust TV is a USP produced video series hosted at usp.org slash trust dash TV and on USP's anniversary hub. Trust TV invites leading thinkers from science, medicine and industry to consider trust's role in helping people to live longer and healthier. New episodes will be added to usp.org slash trust TV throughout 2020. Another initiative is Trust Experience. This digital visualization experience invites users to explore the relationship between USP public standards and the medicines. It illustrates how quality medicines help people live longer and healthier. Users can investigate the history of USP standards. They may explore how standards and related programs improve the medicine quality worldwide. And users can meet the experts of USP's Global Health Science Network. The last initiative is called Trust Needs Champion. Trust is one of the most important ingredients in medicine. Trust is built through our obsession with scientific rigor, our independence as an organization, and the quality standards we set. The development of our standards are our expert volunteers who are not influenced by politics or profit. They are independent. They contribute their expertise to the public good and they provide integrity in a complex healthcare environment. You may prefer a colleague to join our talented team of expert volunteers building trust in the future of medicine. You may go to usp.org slash trust needs champions. If you want to know more about those initiatives, I invite you to visit our anniversary web hub for more information on the USP.org website. The third part of this presentation is about the convention. USP convention takes place every five years. This is a critical milestone in the life of the USP. What is the convention? Convention includes 4992 member organizations from across science and healthcare and from around the globe. Each member send a delegate to the convention. Those member delegates gather every five years for important governance decisions. And throughout the five-year cycle, the USP convention works together to advance priority issues that improve public health, patient safety, and access to quality medicine. Last convention took place on May 4, 2020, so a month ago. Convention met for the first ever virtual USP convention meeting for quite obvious reasons. They approved 15 resolutions. Those resolutions will guide USP's work throughout the next five-year cycle starting actually today, officially. They elected the council of experts that will then set the 29 expert committees who will oversee USP's scientific and standard setting decisions. They also elected the board of trustees for USP's 2020-25 cycle. The board of trustees will guide USP's policies, finances, and strategic decisions. Eventually, the convention approved by-laws amendments that will help USP continue to evolve as it enters its third century. The USP website under the menu about, you may find all the outcomes of this convention. Resolution, Council of Expert, Board of Trustees, and the by-laws amendments, as I discussed before. Here are the 29 expert committees for the new cycle 2020-25. There will be 29 expert committees during this cycle. They are split into six categories, chemical medicine, standards about chemical medicines, API, and finished dosage forms. Biologics, all kind of biologics, from vaccine to monoclonal antibodies, from peptides, proteins, and so on. Excipients, monograph for excipients. Dietary supplements and herbal medicines, food ingredients, monograph for those products. Healthcare quality and safety. And of course, seven general chapters, committees. Many of them existed in the previous cycle. Some are new. In the bio section, you will find a new committee on advanced therapies. In the excipient section, you will find a new committee on excipient test methods. Mission, evaluation, and labeling under dietary supplement, herbal medicine, and food ingredients is also a new expert committee. Another one is about healthcare information and technology. And last new committee under general chapters is about measurements and data quality in this group. Convention adopted 15 resolutions that will guide USP's work during 2020-25 cycle. There are about collaboration with FDA and other stakeholders on health priorities. Efficiency in standards development and revision, quality standards, access to biologics, innovation, digital transformation of standards, education and training for industry and healthcare professionals. Regulatory systems strengthening, compounding, cannabis. Homocopial cooperation and convergence. This is about harmonization, evidence generation to inform policy, coalition building, culture of excellence, and impact expansion. Again, as previously said, you may find the details of those resolutions in the USP website. The last section of this presentation is about USP and its response to the COVID-19 pandemic. USP is playing a critical role in the public health response to COVID-19 disease. We have worked on three different domains. The first one is supporting frontline workers. They are impacted by shortages of critical drugs and personal protection equipment. Another domain is about helping accelerating the work of scientists and manufacturers who are developing vaccines and treatments for COVID-19. We are also advocating to build a more resilient global medicine supply chain. As said previously, USP is supporting frontline workers. We talk about doctors, nurses, all the staff in contact with patients. Aware and still are impacted by shortages of critical drugs and personal protection equipment. We developed operational consideration for sterile compounding. The idea here was to include assigning beyond-use dates for compounded sterile preparations to mitigate drug shortages. We also created a comprehensive hand sanitizer toolkit to support pharmacies, manufacturers, and others, including distillers, seeking to address hand sanitizer shortages. We responded to shortage of garb and personal protective equipment for compounding with conservation strategy. Many companies and laboratories around the world are actively searching for vaccines and effective treatments. You can see that in any newspaper or internet. It's very, very active. USP is helping to accelerate the work of those scientists and manufacturers by pre-technical assistance, by scientists and manufacturers who work on new vaccines and treatments to address COVID-19. They can now access the USPNF online for six months. This offer is valid only for those who are not current subscribers of the USPNF online platform. We are also providing on-demand education with a 75% discount. Eventually, we are also launching new performance standards that support development of critical COVID-19 treatments. First one is the USP monoclonal IGG system suitability reference standard. It was developed to establish requirements for system suitability for the test methods in the USP General Charter 129. This General Charter 129 is about analytical procedures for recombinant therapeutic monoclonal antibodies. In addition, three new monoclonal antibody reference standards for IGG1 subclass are now available. These reference standards can be used for many non-companial purposes that a laboratory may need. We are also advocating for more resilient global medicine supply chain. The USP published a white paper called pandemic preparedness for regulators in low and middle-income countries. This paper contains recommendations to mitigate the impact of the pandemic, to ensure access to quality medicines, to support local manufacturers to utilize quality standards. Ultimately, aim is of course to keep patients safe. Today, patients in the United States and around the world depend on medicines sourced from and manufactured around the globe. Same goes by the way for the ingredients used to make those medicines. This global supply chain for medicines has numerous vulnerabilities. Acute disruptions may occur and concerns arise regarding the quality and safety as well as shortage of medicine. This is particularly true for those used for critical treatments. Unfortunately, the COVID-19 pandemic brought these impacts into sharp focus. To make this supply chain stronger, USP made 11 suggestions in this document on various domains such as geographic diversity of manufacturers, invest in more manufacturing capacity for critical medicines, enable more transparency and data sharing, a need to conduct crisis contingency planning and action, as well as strengthening of the regulatory systems and quality assurance. This is my last slide for today. This is about USP, NF and Thamacoper forum. Another decision very practical was the extension of the official effective dates of the USP and NF. We also extended the comments deadline of the PF-462 that was published in March, April 2020. Both USP-43 and F-38 and its first supplement will become official on November 2020 instead of May 1st 2020 for the USP-43 and F-38. Extension of the food chemical products about food ingredients was also decided. This is because we recognize that stakeholders were facing numerous challenges as a result of the COVID-19 global pandemic. Because USP-43 was originally becoming official on May 1st 2020, this extension aimed to not add any additional burden on them. With this, I have completed my presentation and I will hand over the mic to my colleagues. If you have any questions, please let us know. Thank you very much for your attention. Thank you very much, Beno. Excellent job. This was a very nice presentation. Spent 15 years with the USP but haven't heard of USP either way you just described it. Thank you very much and I hope for everybody who was participating to this webinar, you've benefited as much as me. So what I would like now to suggest to all of you, since there is some time to address some of the questions that you have been given us through either the chat or the Q&A section, you may continue to ask questions through either two ways, chat or Q&A, and we address them as they come in. So one question that we've got was what's the difference between USP and NF? The difference is fairly easy to understand. The National Pharminary contains monograph or excipients. The USP itself contains anything else. That means basically the APIs, the finished dosage forms, as well as dietary supplements monograph. The reason why USP and NF are separated from each other, it's because actually USP took over the National Pharminary in the 1970s years. And I think it was in 1975, which was making a lot of sense, of course. So basically NF is about excipient and USP is about the rest. Thanks Beno. We have another question coming in. How are USP work together with, for example, farm Europe? The European Pharmacopeia, I believe. USP, it's part of the 15 resolution, by the way. One of the resolutions say that USP is expected to collaborate with other pharmacopeia, not just the European Pharmacopeia. We work with the European Pharmacopeia and the Japanese Pharmacopeia in a group called the PDG, the Pharmacopeal Discussion Group. This group that was created in the late 80s, already 30 years ago, aims to harmonize excipient monograph, not all of them, the best sellers, as well as a certain number of general chapters that are widely used. This is a retrospective harmonization. Each pharmacopeia has a monograph for an excipient. And the goal is to make one monograph out of the three from the three different pharmacopeias. So this is one way to collaborate. Another way to collaborate is on what we call prospective harmonization, where there is no monograph for a given API, and here I talk about API, in both EP and USP. With the support of the manufacturer of the industry, of the owner of this API, we can collaborate together in order to develop a monograph that ultimately will be harmonized in both compendium. USP also work with the British Pharmacopeia for this prospective harmonization, British Pharmacopeia, because they produce, they have a finished dosage monograph. So we work with the British Pharmacopeia the same way as we work with the EP, but this time on finished dosage forms. This is the most relevant topics of collaboration between USP and EP. There are also discussions between our two CEOs for sure and other type of collaboration, but those collaboration, those harmonization that I mentioned before are the most relevant for the industry. Thanks, Benoit. The other question that was coming in right before you started explaining the collaboration between the two pharmacopeias and others that you've also mentioned regarding our view on the harmonization of monographs between the pharmacopeias. And I think you've partially answered this already. However, if you would like to expand, please feel free. Well, as I said, it is part of the resolution for USP to harmonize and we definitely consider that harmonization is an important topic. There is no doubt about that. So we are striving to make sure that those monographs are harmonized, but it is a very long process and a very difficult process. There are a lot of hurdles. And one of those is, maybe not the least one, is the scientific opinion of each pharmacopeia. I remember a long time ago, we had Alex and I, we had a very nice colleague. One of his favorite jokes was harmonization. Well, you have three people around the table and they say harmonization. Well, it's very easy. So long you do it my way. And that is a joke, of course, but that is also a way to describe how difficult it is to harmonize. We are not as rapid as we would have expected for sure. It's a very slow process, steady process. We do invest quite a lot of time in this process, but also EP and JP as well. Yeah, this is what I can add to what I said before. If you have anything else, Alex, to add on this topic, feel free. Thanks, Benoit. No, I'm fine. What I would like to suggest is before we continue with the other questions that just came in. Also for our sake, to complete the webinar as planned, we would like to bring up a quick poll for the people to address their answers to, so that we get kind of a response from, you know, how well we've been delivering the material and how much you've been able to absorb from the presentation. So please, only two questions. What is the role of the convention? Does it adopt resolutions? Elect chairs of expert committees? Does it elect Board of Trustees only? Or actually does it all of the both? The second question is how often does the convention meet? Is it every five, seven or ten years? Very difficult question. We'll give it a couple more seconds and then we close the poll and continue with the other questions that came in. Benoit, I think that's something that was addressed to your region since you are responsible for MENA. The question was why USP doesn't have a lab or office in the MENA region? Well, that is not the first time I heard this question, by the way. Why don't we have an office in MENA region? Well, this is not my, I'm not entitled to, empowered to answer to this type of question. It's more political, let's say, CEO decision. I probably can help with that as well, Benoit, since I've partially answered this to the individual who actually raised the question. In fact, we do have laboratories in the MENA region, but they are in a different capacity. As Benoit explained, we have a fund, the program called PQM Plus, which is kind of independent of our operations within USP. So these labs are supporting quality of medicines with the standards from the USPNF to help regulatory agencies to better control incoming goods and locally manufactured products. Wouldn't you agree, Benoit? Yeah, you refer to the National Drug Control Lab of each MENA countries. There is a so-called under this PQM program network called NOMCO where those National Drug Control Labs, they work together in order to exchange best practices and learn from each other. This is something that is, let's say, I don't know if we can say monitored or driven by USP, but for sure we're doing to fear in that. But a real USP lab in MENA region like we have in India or in China, we don't have that. I think, well, I mean, the question is, do we need a lab? What would be the purpose of this lab? I want to say one thing about the lab we have in India, for instance. We have a lab in India or in China, not because the local market required it. We simply have a lab in those countries because in those countries there are a lot of very valuable scientists. And we decided to expand our lab in the United States in those countries just to add additional capacities and benefiting from the local expertise. But what I mean here is that the local labs in India and China are not dedicated to India and China. They are dedicated to USP work in general. Perfect. Thanks, Beno. Back to the convention. First, let's see the results. Actually, all of the above is the correct answer. Do adopt resolution, leg chairs and leg board of trustees and we meet every five years. And I can also come back to a question that was raised. What kind of organizations attend the convention? Only agencies, also pharma representatives or associations? The convention is very diversified. The members are coming from all around the world, first point. I think if I'm not mistaken that around 25, 27% of the members are non-US organizations. The members are very diversified in their nature. We can find regulators. We can find all kinds of associations, pharmaceutical associations, nurse associations, consumers associations, anything you may think of. So there are certain groups that are defined within the convention. And what we try is to have in each of those groups a sample of members that are sufficient and to provide good insight from their own activity. So it's very diversified in the nature of their organization and it's very diversified in the global presence. Next slide. What I want to add is that the delegate of each member is actually, of course, representing the organization he or she works for. This is totally different when we talk about experts working in the committees. You remember I talked about 29 different expert committees where you will find roughly 900 volunteers, 900 experts. Those experts, of course, they work in the industry, in the academy, as a consultant, anything. And they represent themselves only. They don't represent the organization for which they are working for. And this is very important, of course, because we want to ensure that there is no conflict of interest. So if, for instance, during a committee meeting, a decision has to be taken that may impact the organization for which a specific expert is working for, then it has to withdraw from the vote. In order to avoid any conflict of interest. So again, members of the convention, they represent the organization they work for, members of the expert committees, they represent themselves. And they are only there due to their expertise, scientific expertise. Thanks very much. While we were talking, there was a last question coming in regarding organization. Do we also consider working with other countries, meaning other pharmacopias like China? And I can quickly respond to that saying, of course, during these international conventions, all representatives are participating and our representative on the PDG is in constant discussion with the different pharmacopias, whether or not they're going to be part of PDG is a different question. But the collaboration between our organizations is happening. There is a... Go ahead, Beno. There is indeed a collaboration between all the pharmacopias of the world. I think we talk now about 35 or 36 different pharmacopias, plus or minus a couple. And those pharmacopias, they gather, I think, once a year. And the aim is not to harmonize standards, but the aim is to prepare what they call global pharmacopial practices. So the aim is to, let's say, harmonize not the standard itself, but more or less the way they work, the way they approach and they create a monograph. So it's more on general basis. It's called global pharmacopial practices. Yeah, maybe some comment from my side, Christian here from the background. We have that cooperation. It is called International Meeting of World Pharmacopias, IMWP. And if you enter International Meeting of World Pharmacopias IMWP together with HWO for the World Health Organization, you will probably find in your search machines a link to the IMWP part at the HWO website. And you can see then there all the cooperation that is going on. There's also some cooperation about COVID at the moment. And you will be linked through that website also to these activities. Perfect. Thanks, Christian. While you are actually talking, we have two more technical questions that you maybe want to address. First is, USP monographs have impurities which are not available at reference standards. If we can provide the structure of these in any way, shape or form. Yeah, that is still something that is going on in discussions if you should include these structures also in the monographs. I think the attendee that asked the question is also referring to the way how the European Pharmacopia is doing that. We are including already some structures for impurities, but the attendee is right. We don't have yet those for those impurities where we don't have standards. What we do, however, is and that is already a big step is that we include tables with impurities that can be controlled and that can also show up in the monographs. But so far they are mainly by the name there and not not directly always with with structures. Yes, but but this is something that we are always considering and and hopefully it will come into into the newer versions of monographs. But but this will probably take a little bit a while until this is available for all impurities that I mentioned. Yeah. Thank you, Christian. Another question more technical is why appearance test is not part of a monograph. Yeah. Ben, why do you know the answer to that because I I think well. Yeah, go ahead. Yeah. It's a very good question and it is a it is a I was laughing a little bit because it's it's it's a funny one, I believe. In the past, you could find description and solubility in the individual monograph. And we were stating that this section within the monograph was not official. This and and I think that the European for my copia does the same. They also have this description and solubility section in the monograph. Non official. And then I don't remember. I don't know exactly when but long time ago already. Industry told us, could you please remove this description and solubility section that is currently in the monograph. Can you please remove it because we get questions from regulators when they inspect. And this is not official. So why do we have to comply with. So we decided a long time ago to remove this section from the monograph and to put that in a separate section in the usp and. This is the the answer to to your question. This is not official. This is therefore in a separate section from the monograph itself, which is of course, official. Of course, there are people who asked why description and solubility is not included in them over. Well, I don't think we will go. We will revert to the previous situation. So it's a long discussion. There is pros and cons. This is the current situation right now. Thank you very much. Several of the participants have also asked whether the presentation material can be made available. Unfortunately, we cannot. But as Christian mentioned to a person asking this question privately. He said that he is recording this issue, which will be made available online at some point. Yes, we have the usp channel where a lot of webinars are. Yeah, are available online on demand and there on that usp YouTube channel, our webinar will also be put and we can let them. Our, our stakeholders in the region and overall can can let them know. I may add as well something Alex and myself, we are both strategic customer development managers. That means our role is to support local industry and provide them with all kind of assistance, all kind of support in terms of science in terms of logistic and so on. Christian is our technical manager here in Europe, Middle East and Africa. He can also provide it with a lot of technical support. The STD's group around the world is more than two people, more than just Alex and myself. We have STD's in United States in Latin America, Southeast Asia, India, China and so on. All this, this network of STD is available to any local manufacturer. On top of that, there are three colleagues in United States, Lisa Corbin, Brian Gilbert and Robert Lafaveur. Those three people are responsible for answering to this technical question specifically on a monograph or a journal chapter. They have access to the dossier so they can easily refer to the dossier to provide the correct and accurate answer to any question we might receive. So if you have any question about USP, you may reach out to either Alex or myself or any other STD colleague around the world. Probably, I mean, either the STD will answer himself or herself or most probably they will forward the question to those three colleagues I mentioned before so that you can get the answer. Lisa Corbin is responsible for any technical question regarding the reference stand up, usage, storage, shipment and anything you may think of as long as it refers to reference stand up. Brian Gilbert is responsible for technical questions about the USP itself, remember the first question we had and Robert Lafaveur is in charge of questions about the NF monograph as well as journal chapter. Thanks, Benoit. To your answer on the appearance of not being part of the monograph, the same person asking the question came back saying it is compulsion to comply the description and solubility or it depends on manufacturing process. Sorry, it is what? I think the question is it compulsory to comply regarding the description and solubility or does it depend on the manufacturing process? Well, as I said, a description and solubility is not official. That means you don't have to comply. It's not compulsory. I'm not a pure specialist, but if you have a powder that is supposed to be off-white, what means off-white? That's a good question. This powder is off-white. No, no, this one is off-white. So what means off-white? I mean, it's kind of, it's fairly difficult. So as this is not easy to identify, definitely this section is not compulsory. But of course, it gives a very good indication. If you get a powder that is expected to be off-white and the powder is red, then you need to question yourself probably. So it gives a good indication on how the powder should be, for instance. But again, it's not official. Yeah, but there could be also that white powder with black speckles in it and it would not be really then the official text, but there is other chapters, for example, on foreign materials that need to be taken in consideration. So you cannot say, for example, if you have a white powder with black speckles in it, I can take it if everything else in the quality attribute from the quality attributes is fulfilled. You cannot say then it is still fine because then comes the chapter on the foreign materials into play. And from there, you are then required to check what are these speckles, even if all quality attributes from the monograph would be fulfilled. A lot of good questions. Absolutely. Absolutely. There is one. Why USB reference standard are not available at regional level wherever possible to reduce lack time during procurement. That's a very, very good question, especially in these times where we face delivery instances that are out of our control. Sometimes it really would make sense to have it on a local level. However, what we have installed for many years already is a global agreement with our freight forwarded to deliver reference standards from our stock to the airport nearest to the consignee within two to three working days. And this is almost even bet at times because when you order our reference standards until four o'clock European time EST, you will get the material shipped in the same evening, considering it doesn't contain any special reference standards such as dangerous goods or controlled items. So every regular reference standards is being shipped at the same evening. And probably most probably available the morning after the issue very often with the lack of delivery of reference standard is not the delivery between the states and any other regions. It's mostly custom clearance and other brokerages. So sometimes customers are using their own brokers. And due to experience of doing that, we are experiencing delays as well claims coming from customers. So whenever possible, and you can use or accept our grateful water that we have defined as it is, please do so because they have the most experience locally to clear the goods from customers, and also send you immediately the material with the request for payment of all the duties. And we experienced this to be the fastest way. However, as I said before, especially during the beginning of the outbreak of the pandemic, when flights were reduced to a minimum, we experienced delays. And it's probably a good time now for all the attendees who are participating to this webinar to let you know that we try to ensure everything possible that the materials being shipped in time. However, sometimes really beyond our control, we also ask for your local support to make sure that whenever the product is already in the given countries that you pay attention as well with the clearance of the goods in time. So thank you very much for that question. Any other questions that we have seen? Is the USP standard adopted in the whole world? Benoit, would you like to take that? Well, if I understand correctly, this question is the USP standard adopted by in the whole world. That means we do we have to comply with USP standards wherever we sell the drug. Is it what I understand? Do I understand correctly? If that is the correct question. Well, if a drug is produced anywhere in the world and market in the United States, then of course the drug must comply to USP standards as per the law of USP standards in 1938, the food drug and cosmetic act. If a drug is produced for another market, well, it depends. I mean, if, for instance, it is produced for the European market, you may comply with European Pharmacopoeia. If it is for Japan, you may comply with Japanese Pharmacopoeia. So there are multiple ways. And if you say if you produce a drug, for instance, in Saudi Arabia, and you want to market this drug in Jordan, for instance, the Jordan FDA recognize the USP as well as they recognize other important pharmacopoeia such as the European Pharmacopoeia. So there is to summarize my answer, there are countries where there is a local pharmacopoeia, USP in US, European Pharmacopoeia in Europe, Japan, Japanese Pharmacopoeia in Japan, where you have to comply with the local pharmacopoeia, of course. There are also many other countries where there is no local pharmacopoeia and then normally usually their local regulator requires compliance to a pharmacopoeia like the USP, EP and so on. But it's not mandatory. But it's also linked to the dossier that you submit to the regulator. Thanks Benoar. We have another question regarding controlled substances and how to procure them. It's a special way of doing so we have a department at USP in customer service dealing only with controlled substances. They are in contact with the drug enforcement administration authority who is controlling transit of narcotics and other controlled substances. They need to apply for permits to internationally dispatch products and they only can do that with a permit from any local government of which the customer who needs that customer controlled substance is to provide a permit for importation. In other words, the process would be for you individually if you need a controlled substance to ask your local authority for the permit of importation. That document needs to be sent as an official document together with the official letter of procurement to our customer service department dealing with controlled substances. And with that, our department is putting together an application package to the DEA which will approve transport or export from the US to another country for controlled substance. This particular department that is responsible knows the details probably in many countries as it is not always easy to obtain permits and regarding formats. We would provide you advice through this department on how best to address your request with your local authorities. But again, as Benoit mentioned before, we can address this as well offline if you have further questions on how to do this correctly. Please send us an email. We just received another and probably a last question because I think in two minutes we will need to close this webinar. What may be some of the reasons ground that USP is sometimes different from the BP in the European Pharmacopia? Benoit, would you like to take that? Do you want me to take it? So, if I understand correctly, why is the monograph in the USP sometimes different from the one you find in the European Pharmacopia? This is the question. I guess this is what the individual means by reasons and grounds that USP is sometimes different. I cannot really speak on behalf of the European Pharmacopia, but let me speak on behalf of the USP. When we develop a monograph, we actually we develop a monograph based on data that are sponsored to USP by a company that is approved by the US FDA. So, let's say you are an innovator, you create a new drug, so you will, if you want to sell it to the United States, you will apply for market authorization. You will provide a lot of data on quality, on safety, and efficacy. This is the CTD, but you will provide all those data to US FDA. They will review those data and eventually they will say, okay, based on the quality level that you proposed, I do agree that this drug will be safe and effective, so now you can sell it. We need to develop the corresponding monograph because we aim to have in the book the monograph corresponding to any drugs market and approved in the United States. So, we then go to the market authorization holder and we ask them, can you provide USP with the data on the quality side that were reviewed and approved by FDA so that we can develop a monograph out of it. So what I mean here is that in the USP monograph eventually you will find data acceptance criteria as they were approved by US FDA. So, we do not change anything really because otherwise we would have an impact on safety and efficacy. And you remember from the presentation that USP has no impact on safety and efficacy, we are only dealing with quality. So, what is in the USP monograph reflects what FDA has approved. And this is also why FDA can then enforce USP monograph because they will enforce what they have approved before. So, this way we develop a monograph data in the USP and now, of course, if in Europe, it is the process is similar. That means that eventually if both regulators have approved the same, then of course the monograph may look the same more or less. But if there are differences between what FDA has approved and what EMA has approved for instance, then at the end the content of the monograph may differ. So, again, we have in USP monograph the data, all the acceptance criteria and so on, they do reflect what FDA has approved. And therefore there might be a difference with a monograph from another story. Thanks Beno. Last but not least, thank you very much for all your participation and active questioning. I think it was a very nice Q&A session right now. I think for the sake of time, we really have to close the webinar now. But we encourage you to stay in touch with us, contact us for any future question that you have. As Beno said, we are here for you and we want to support as best as we can your query related to USP topics. Thank you very much Beno for really putting together a nice presentation and presented in a very nice way. Thanks Christian in your background. We will stay available for you. And as I mentioned at the beginning, we'll have more webinars to come. So, some of you we might probably see again. Thank you very much. Have a good time. Stay safe. Thank you very much. And healthy. Bye everybody. Bye bye. Thank you. Bye bye.