Susan Haigney

CPHI Frankfurt 2025: Regulatory Challenges for Global Manufacturing of Vaccines

The COVID-19 pandemic brought light to the global importance of vaccines and ensuring they are manufactured to quality standards for every region in which they are used. At 

Vishal Mukund Sonje, Vaccine Manufacturing Lead at the Coalition for Epidemic Preparedness Innovations 

(CEPI), will be discussing some of the challenges faced for vaccine manufacturers, especially those working hard to get these products to remote regions, including complex regulatory requirements.

“Development and manufacturing regulations for vaccine development are quite stringent. However, these requirements are essential, since they ensure product safety and efficacy,” Sonje explains. “The main regulatory bodies … USFDA and European Medicines Agency… they enforce rigorous standards for maintaining high quality of vaccines. And this is essential, since vaccines are injected into healthy individuals. There are also efforts to harmonize regulatory standard across countries, for example, ICH [International Council for Harmonisation] guidance. These guidances ensure that there is streamlined approval and global distribution possible, mainly in the LMIC [low- and middle-income] countries.”

Sonje explains that vaccine manufacturing is complex and requires decades of experience. “It also involves significant CapEx [capital expenditure] investment,” Sonje says. “Apart from that, knowing post-COVID pandemic period, it is essential each region enables different platforms that can be used in a pandemic situation. The platforms that can be used are mainly categorized into recombinant protein, viral vector and mRNA [messenger RNA].”

Sonje will be presenting the case study, “How to Pave the Road to African Manufacturing Equity?”, at 

on Wednesday, Oct. 29, 2025 at 3:45 PM (CET) in Hall 4.1–4.1J48.

Click on the above to watch the interview.

Vishal Mukund Sonje is Vaccine Manufacturing Lead at CEPI.

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Vishal Sonjay. I work as vaccine manufacturing lead in Cepi. Cepi stands for pollution, for epidemic preparedness and innovation. My job title is vaccine manufacturing League, and I'm based at London office of Sepi. My responsibilities are mainly in the CMC and vaccine manufacturing. I support to enable capabilities and capacities in lower and middle income countries for vaccine manufacturing. Prior to this, I work in big pharma, mostly in vaccine industry, in in departments and functions spanning from industrial affairs, supply chain management, CMC development, manufacturing supply And MJH division. I worked right from industrial operations, early development of product, till who pre qualification, I was fortunate enough to witness a complete product life cycle, from early, early development to the WHO pre qualification that enabled me to have a good technical depth and understanding of vaccine development, and I could enable or use those skills in my experience at Cepi.

how do complex global regulations and legal rules inhibit or help vaccine manufacturing?

Development and manufacturing regulations for vaccine development are quite stringent. However, these requirements are essential, since it ensures product safety and efficacy, the main regulatory bodies if, if I want to bring up their who, USFDA and European Medicines Agency, they enforce rigorous standards from maintaining high quality of vaccines. And this is essential, since vaccines are injected into healthy individuals. There are also efforts to harmonize regulatory standard across countries, for example, ich guidance, who pre qualification. These guidances ensure that there is streamline approval and global distribution possible, mainly in the LMIC countries.

Are the specific manufacturing issues pharmaceutical companies should consider when manufacturing a vaccine that will be used globally, especially in areas where the vaccine may be the most needed.

Vaccine manufacturing involves complex bioprocessing, and it needs years, if not decades, of experience to develop technical depth and know how. It also involves significant CapEx investment. Apart from that, knowing post pandemic covid pandemic periods, it is essential each region enables different platforms that can be used in pandemic situation. The platforms that can be used are mainly categorized into recombinant protein, viral vector and mRNA. Thirdly, manufacturers need to keep in mind overall ecosystem and external environment that could have large impact on the success of manufacturing capabilities, for example, maturity of the regulatory authority, input material, supply chain, cold chain, infrastructure, finished goods supply chain. For example, shortage of critical components could be challenging to manage and can have detrimental effect on the planning of manufacturing. These factors are essential for any region or manufacturer to keep in mind before moving into vaccine manufacturing. These factors is key reason why there is certain advantage for manufacturers in certain regions and at the same time, is it? It is equally challenging. For these reasons, there are some advantages for manufacturers in certain regions like global north or Asian economies like India and China, while it is challenging to set up new facilities in New LMIC regions such as Africa or Latin American region.

Are manufacturers moving to patient centered manufacturing for vaccines and creating modular manufacturing centers closer to where the vaccines are specifically needed.

Overall, the trend in pharmaceutical industry is is more personalized medicine or more close to the end user. However, for vaccines, we still do not have a personalized vaccine development pace. Having said that post covid pandemic, there is increased sense of urgency from all regions to enable vaccines self sufficiency and manufacture within the region, so that during pandemic period, the companies can can shift their manufacturing base and and to manufacture vaccines and medical counter majors to counter the pandemic situation. Keeping that in mind, as I said earlier, three platforms that are mainly looked after or developed by these companies in LMIC regions, namely viral vector protein subunit and mRNA. So LMIC regions, for example, Africa, together with Africa, CDC, a newly formed health agency in Africa, is looking to develop capabilities in Africa for manufacturing based on these three platforms.. So what can you tell me about your presentation at cphi, and what are you looking forward to most at the event this year, sure,

This year in cphi, we are bringing a topic on enabling vaccine manufacturing equity in Africa. To start with little bit of background Africa, CDC has set a target of manufacturing 60% of vaccines or antigens required for local African need by 2040, this is moonshot target, and it equally needs a big effort and large capex. And Africa, CDC has enabled, through Africa vaccine manufacturing accelerator and avmi African vaccine manufacturing initiative efforts are underway through these two organizations and Africa CDC has listed eight antigens.

in line, in line with my earlier thought Africa, CDC has set a target of manufacturing 60% of vaccines by 2040, locally, there is a big effort already underway to establish manufacturing industry in Africa. And Africa, CDC has come up with a list of eight antigens to support this through avmi, that is African vaccine manufacturing initiative, Africa, CDC, streamlining activities to coordinate these efforts, to enable and to make this industry viable, supply chain is a crucial factor. CP, together with Africa, CDC, sponsored a supply chain assessment, and it came up with three main pillars that can enable or streamline the supply chain management. These three were localized manufacturing of raw material, pool procurement of raw materials. And third is removing trade barriers across countries in Africa. After this workshop Africa, CDC, together with CP has come up with an approach or model to come up with practical actions in each of these pillars, specifically for pool procurement, model is considered a quick win, while localized manufacturing and removing trade barriers is a long term action and action plan is being worked out already in this particular workshop, CP is proposing a pool procurement model that is developed together with a consultant called mindco, and we are looking forward to create awareness about what input materials have been identified.

With this workshop, we are looking to create awareness amongst raw material manufacturers or vendors. We want to bring awareness about increased manufacturing capacity in. Africa, that would also mean there is growing demand of all the raw materials. We want to share different models for pooled procurement, and if vendors are interested in setting up their manufacturing base or distributors, what kind of support is available from multilateral organizations such as Africa CDC and Sepi. Sepi and Africa CDC team would be available by the sites, by the lines of this workshop, and interested parties can discuss further. Sepi, together with Africa, CDC, would be available by lines of the workshop and interested pool procurement vendors and suppliers are encouraged to discuss for the business opportunities

Videos

Vishal Mukund Sonje, Vaccine Manufacturing Lead, CEPI, talks about the challenges that arise in the manufacturing of vaccines in various global regions and gives a preview of his presentation at CPHI Frankfurt 2025.

CPHI Frankfurt 2025: Fiber-Based Packaging for Sustainability

Sustainability in pharmaceutical manufacturing has become a prominent reason for certain decisions made by pharmaceutical companies and contract manufacturers. Companies have set out to meet certain environmental standards set by regulators and the companies themselves.

Choices in pharmaceutical packaging materials play a role in these sustainability efforts. 

® spoke with Maija Pohjakallio, VP, Climate and Circular Economy, Metsä Group, before her presentation at CPHI Frankfurt 2025, to learn more about fiber-based packaging and how it can help pharmaceutical companies meet their sustainability goals.

“By definition, fiber-based packaging means packaging that is made of paper or paper board. Paper and paper board is made from pulp, and the typical raw material for pulp is wood,” Pohjakallio explains. “First of all, the wood has to be sourced from some sustainable sources. All the wood procured by Metsä Group and Metsä Board comes from either certified forests or forests that meet the requirements of controlled origin. The wood that is procured is also utilized in a sustainable way, meaning that the thickest part of the trees (i.e., the logs are utilized for making mechanical wood products, and then the thinner parts, which don't qualify for timber and construction elements that's utilized for making pulp.”

“A very important question related to packaging is that by optimizing your packaging solutions, you can reduce your scope three emissions,” she continues. “And regarding fiber-based packaging, there are two very important elements that actually have a big influence on the carbon footprint on the packaging. One is the share of fossil free energy utilized in the production. And the other one is material efficiency. If you use less fibers in making the packaging of same properties, of course, that means better carbon footprint.”

Pohjakallio will be presenting the Keynote session, “Sustainability in a Shifting World: Communicating with Clarity, Acting with Purpose”, at CPHI Frankfurt on Tuesday, Oct. 28, 2025 at 11AM in Hall 4–4.0G36. She will also be participating in the panel session, “From Compliance to Competitive Advantage: Navigating CSRD and CSDDD”, on Tuesday, Oct. 28 at 4PM in Hall 4–4.0G36. The same day there will also be a small group discussion moderated by Maija on sustainable packaging solutions at 2.00-2:30 PM (Group Discussion 1/Table 1).

Click the above video to watch the full interview.

Maija Pohjakallio works as VP, Climate and Circular Economy, at Metsä Group. She also teaches about materials and sustainability at the University of Turku.

Hello. My name is Mijia and I work as a vice president of climate and circular economy at Metsa Group, and thanks a lot for the invitation to join this interview. Real pleasure. I'm based in Finland, in our headquarters in Espoo, and Metsa Group is a forest company.

What makes us a bit unique is that our parent company is metzalith cooperative, owned by over 90,000 Finnish forest owners. Altogether, we are over 9000 people working at metza Group, but all our production takes place in Europe, and I've been working at Metsa Group for a bit more than four years. But in the beginning of my career, I was working in research and teaching, and also currently I'm doing some teaching at the University of Turku part time, and I teach about materials and sustainability.

Metsa Group has five business areas, and one of them is meta board. Metsa broad produces paper boards for packaging applications, especially for pharma sectors, food sector and cosmetic sector.

Sustainability has been a focus for a lot of pharmaceutical companies in the past few years. How much of this effort has been focused on pharmaceutical packaging?

You increasing amount of pharma companies have a holistic approach to sustainability, and this is driven, for example, by the way sustainability is assessed.

For example, when a company is assessing its greenhouse gas emissions, it's about assessing scope one, scope two and scope three. And scope one and scope two emissions are related to companies, own operations and purchase electricity, whereas scope three is the rest, meaning the value chain emissions, both downstream and upstream and reducing the scope three emissions in that optimizing your packaging solutions plays a crucial role.

Actually, according to a study by McKinsey, 75% of the greenhouse gas emissions of a typical pharma company originates from scope three.

Also, there is a lot of development in packaging and packaging waste regulation in the EU and other parts of the world as well, and that one also drives companies to focus on packaging solutions. For example, in in the Europe, packaging and packaging waste regulation was adopted recently, and it says that all packaging has to be recyclable by 2030 it also gives rules how you have to, for example, have modulated extended producer responsibility fees, and that how you must avoid over packaging.

What is fiber based packaging, and how can it help pharma companies reach their sustainability goals?

By definition, fiber based packaging means packaging that is made of paper or paper board, and paper and paper board is made from pulp, and the typical raw material for pulp is wood.

First of all, the wood has to be sustained, has to be sourced from some.

Sustainable sources. And here in Finland and in the northern forestry, it, for example, means that forests are taken care of and and the wood that is procured is utilized in a sustainable way, meaning that the thickest part of the wood that the logs they are utilized for making mechanical food products, and then the thinner parts, which don't qualify for for timber and construction elements that's utilized for making pulp food.

And if you think of fiber based packaging, one of the great advantages of fiber based packaging is that it's the recyclability of paperboard packaging is really good. For example, in the EU, there's just a new statistic published that in 2023 the recycling rate of fiber based packaging in EU was 86.6% which is really high.

Another very important question related to packaging is that by optimizing your packaging solutions, you can reduce your scope three emissions. And regarding fiber based packaging, there are two very important elements that actually have a big influence on the carbon footprint on the packaging. And the other one is the the share of fossil free energy utilized in the production. And the other one is material efficiency.

For us, if you use less fibers in making the packaging of same properties, of course, that means better carbon footprint. And for example, Metsa board they are aiming. We are aiming that by 2030 all our meals would utilize 100% fossil free energy, and at the moment, the figure is already 89 so at the moment, 89% of the energy utilized in our meals in production is fossil free. And we at metabo, we also pay a lot of attention to light weighting, meaning that with less fibers, you can do more.

In what ways is the drive for sustainability, influencing facility design, process selection and sourcing strategies, strategies and how are companies measuring environmental progress?

An important way to measure your sustainability is to calculate your greenhouse gas emissions, and it means calculating or assessing your scope one, scope two and scope three emissions. And by optimizing the packaging solutions, you can really have a great impact reduce your scope, three emissions. And that, of course, is very How would I say, important and dictated a lot by the sourcing, sourcing actors and the supply chains, how they are formed within the company.

And according to a study by McKinsey of the overall greenhouse gasses of a typical pharma company, up to 75% originates from scope three. So this kind of a sourcing policies play a crucial role in sustainable development. And of course, if we are thinking about scope three emissions, collaboration is key. Collaborating with your suppliers and with your customers, that's that's the way, and that's the power to really develop more sustainable practices.

What can you tell me about your presentation at cphi, and what are you looking forward to at the event this year?

I'm really excited to present so to give a keynote and to participate a panel on the 28th in Frankfurt, and my keynote will be about sustainability in the sifting world. So it's it's an undeniable fact that the mankind we all, we have to kind of focus more on respecting the planetary boundaries.

And we need a green transition, which means not.

Only transitioning to more sustainable ways to utilize energy and materials, but it also means the way we look at value and data,

 and I will be presenting different types of companies approaches to ESG, and also talking about how it can be a strategic choice to bring sustainability in the core of your business strategy and turn it into a competitive advantage. I'll also tell some examples about meta groups and meta boards, sustainability journey, for example, how we have our 2030, sustainability targets that we are aiming to have Fossil Free mills and we are developing regenerative forestry, so meaning raising the bar of Sustainable Forest Practices here in Finland.

Then I'll give some examples how all this sustainability work and our journey is reflected in meta boards products. I will give case examples, study examples, case study examples of meta boards products and comparisons, comparative studies on carbon footprints, and I'm also very much highlighting how it's really the power of collaboration that makes the sustainability transition to happen.

Pharmaceutical packaging plays an important role in sustainability efforts. Maija Pohjakallio, VP, Climate and Circular Economy, Metsä Group, explains how fiber-based packaging can help with these efforts.

Welcome to CPHI Frankfurt 2025

, which will be held Oct. 28–30, 2025, is one of the pharmaceutical industry’s largest events. This year more than 62,000 professionals from the bio/pharmaceutical industry are expected to attend as the conference celebrates its 36th year. The three-day event will feature six content theatres, more than 2000 exhibitors, and expanded content and exhibitor zones that reflect diversification in the industry, such as bioproduction, finished dosage formulation, drug delivery, and packaging, in addition to the usual coverage of APIs (1). To learn more about what can be expected at this year’s event, 

® spoke with Tara Dougal, Event Director for Pharma at Informa Markets.

“I think one of the major takeaways this year is really something that's always been at the heart of CPHI, and that's the ability to partner across the supply chain,” Dougal says. “I think the strength of the show has always been uniting the pharma community and really uniting the end-to-end supply chain from across the globe. And I think in the past year, we've seen a lot of challenges in pharma, particularly on the other side of the pond, around potential tariffs. I really think that's made partnering and being able to get in front of your customers and your clients and your suppliers more important than ever before, to renew those relationships, but also potentially to find and source new partners.”

“I hope that anybody coming to the show this year will go home with a sense of meeting great people, connecting with existing partners, but just renewing those relationships,” she continues. “I think CPHI is that very, very important annual touch point where we can really bring the entire community together.”

Click the video above to watch the interview.

1. Informa Markets. CPHI Frankfurt 2025 to Welcome More Than 60,000 Pharma Professionals as the Global Event Returns to Germany. Press Release. Sept. 5, 2025.

Tara Dougal, Event Director–Pharma at Informa Markets

Tara Dougal is Event Director–Pharma at Informa Markets, where she leads the CPHI Europe event. Tara brings over 12 years of extensive event management experience spanning roles in New York, London, and Amsterdam. She previously held the position of Content Director before advancing to her current leadership role.

At CPHI, Tara plays a crucial role in creating connections and inspiring partnerships across the global pharmaceutical community, championing innovation at the heart of pharma through both in-person and online events.

PharmTech: Can you please tell us about yourself?

 My name is Tara Dougal. I'm the event director for pharma at Informa Markets, and I'm responsible for the CPHI Europe event, which is coming up very soon at the end of October. So, we'll be hosting the show this year in the lovely city of Frankfurt from the 28th to the 30th of October. This year is actually going to be my 10th CPHI. I joined Informa, or UBM, as it was then, 10 years ago. I was originally the content director, looking after all of our content and our conferences that you find on site. And as of January this year, I moved into the event director role, which is really exciting new opportunity for me, and has given me the chance to lead one of the biggest farmer events globally. So yeah, very excited for the upcoming edition of the show.

What can you tell us about this year's CPHI Frankfurt? What's new this year, and are you seeing any specific trends?

 For this year's CPHI, it's going to be a bigger addition than ever before. We're looking forward to welcoming 62,000 attendees from over 166 different countries worldwide, and 2400

exhibitors. So, it's going to be the biggest edition of CPHI Europe as yet. What's new for this year? So, beyond the show floor, getting bigger and better, we have six content theaters this year covering the entire supply chain, so giving you a huge opportunity to update your knowledge, hear from thought leaders, really on all the market trends through from ingredients and formulation all the way to packaging and drug delivery. So, I'd really advise anyone coming to the show to check out the agenda and already start bookmarking the sessions.

If you'd like to join pre-show, we also have a brand new leadership summit for this year. This is open to our leader pass holders and above. This is going to be really, really interesting session held on the morning of the first day of the show, the 28th of October, bringing together C-suite speakers from a number of Big Pharma countries to really talk about the big picture outlook for pharma and to touch on some of the geopolitical and macroeconomic challenges and opportunities that we've seen in the market this year. So, really excited for all of that. 

Of course, we have our awards ceremony on the first night of the show as well the CPHI celebration. This is a really, really exciting evening where we give out trophies across 14 different categories. And it's also an amazing opportunity for networking and connecting on site, whether you're nominated for the awards or not. [I’m] really looking forward to seeing who takes home the trophies this year.

 What should attendees be taking away from the event this year?

 I think one of the major takeaways this year is really something that's always been at the heart of CPHI, and that's the ability to partner across the supply chain. I think the strength of the show has always been uniting the pharma community and really uniting the end-to-end supply chain from across the globe. And I think in the past year, we've seen a lot of challenges in pharma, particularly on the other side of the pond, around potential tariffs, and I really think that that's made partnering and being able to get in front of your customers and your clients and your suppliers more important than ever before, to renew those relationships, but also potentially to find and source new partners. 

I hope that anybody coming to the show this year will go home with a sense of meeting great people, connecting with existing partners, but just renewing those relationships. I think CPHI is that very, very important annual touch point where we can really bring the entire community together. I would be very happy if I felt that people were going home feeling that they'd achieved that.

 What makes Frankfurt an ideal city to host?

 It's always nice to be in Frankfurt. You know, Frankfurt has been home to CPHI many times over the years. And I think a few of the reasons for that are that one, it's a very well-located hub. As I mentioned. We do have attendees and exhibitors coming from all over the world, more than 166 different countries. Logistically, it's very important to us to have somewhere that is easy to connect to, and has good transport links, and that's definitely something that Frankfurt delivers on. 

We also have a fantastic partner in the Frankfurt Messe. You know, we've had a long-standing relationship over the years, and the Messe really gives us great facilities, great experience, and also the room to grow as the show has grown significantly, since the very first edition, which was in Frankfurt, 36 years ago. And also, I think it's very important to mention that Germany has a thriving life sciences industry, and Frankfurt is home to many biotechs and pharma companies. So, it's really nice to be able to host the show in such a strategic location.

 And do you have any advice for attendees this year?

 My advice to anybody coming to CPHI, if you are a veteran or you're a first timer, I would suggest just planning ahead. It's a huge show. You're going to be doing a lot of walking over three days, so bring comfortable footwear. Make sure you plan your schedule way in advance. And I would really recommend everyone taking a look at a lot of the activities that we have beyond the show floor … the content, the networking opportunities, such as the awards, CPHI celebration that I mentioned, and our happy hours that we have on days one and two. These are open to anybody attending the show. They're free to attend. So, make sure you join and you take part in what are going to be great networking opportunities. There's so much happening at the event, and you can really just scrape the surface if you don't plan ahead. Our event app is a really, really great tool for that. You have the full agenda on there. You can already have the exhibitor list, and you can start reaching out to prospective meetings already through the app, getting a bit of a head start at your time the show.

Pharmaceutical Technology® spoke with Tara Dougal, Event Director for Pharma at Informa Markets about what attendees at CPHI Frankfurt should expect this year.

 which will be held Oct. 28–30, 2025, is one of the pharmaceutical industry’s largest events. This year more than 62,000 professionals from the bio/pharmaceutical industry are expected to attend as the conference celebrates its 36th year. The three-day event will feature six content theatres, more than 2000 exhibitors, and expanded content and exhibitor zones that reflect diversification in the industry, such as bioproduction, finished dosage formulation, drug delivery, and packaging, in addition to the usual coverage of APIs (1). To learn more about what can be expected at this year’s event, 

Watch the video version of this interview here.

Articles

CPHI Frankfurt 2025 is set to be the largest edition yet, with over 62,000 attendees and 2,400 exhibitors from 166 countries. The event will feature six content theaters covering the entire pharmaceutical supply chain, a new leadership summit, and an awards ceremony. Attendees are encouraged to plan ahead to maximize networking and learning opportunities. Frankfurt is an ideal host city due to its strategic location and strong life sciences industry. The event emphasizes the importance of partnerships across the supply chain, especially amid recent industry challenges.

Tara Dougal Welcomes You to CPHI Frankfurt 2025

Doctor using AI-powered health data dashboard to monitor patient analytics, medical statistics, and clinical decision support in real time. | Image Source: ©Suriyo - stock.adobe.com

The pharmaceutical manufacturing sector is currently navigating an era defined by accelerating complexity, personalized medicine, and rigorous regulatory scrutiny. For manufacturers, the use of real-world evidence (RWE) has become a fundamental, mandatory asset that enhances drug safety, streamlines regulatory compliance, and accelerates future drug development pathways.

based on collected patient health information from such sources as electronic health records, medical claims, and product or disease registries (1, 2). RWE is clinical evidence about the usage, benefits, or risks of a drug product and is derived from analyzing RWD (1,3). Successfully integrating RWE into development and manufacturing protocols can maintain both product integrity and regulatory advantage.

Is RWE a mandatory component of the drug lifecycle?

For pharmaceutical manufacturers, the most immediate and critical application of RWE is in monitoring post-market safety. The lifecycle of a drug product does not conclude once it reaches the market; rather, it extends beyond approval, relying on data from patient use to inform continued safety testing (4).

RWE is a part of pharmacovigilance activities (4,5). Manufacturers must gather RWE for the entire time a product is on the market (4,5). This is essential because, while side effects and indications are identified in clinical trials, opening the drug up to the greater population often reveals additional side effects, as the product affects individuals differently, particularly outside the controlled environment of a clinical trial (4, 5). Whereas RWE collation may not have been required in the past, it is now expected to be a staple because of benefits it delivers (4,5).

Regulatory agencies are building infrastructures to facilitate RWE integration. In the United States, FDA’s Center for Drug Evaluation and Research (CDER) established the Center for Real-World Evidence Innovation (CCRI) to coordinate and advance the use of RWD and RWE in regulatory decisions (1). In Europe, the European Medicines Agency (EMA) advises using high-quality RWD in decision-making and is creating a flexible framework to deliver rapid access to and analysis of RWD throughout a product’s lifecycle (1,2). Resources for manufacturers include the public electronic RWD catalogues launched by EMA and the Heads of Medicines Agencies, which can help identify suitable data sources for research and assessment of study protocols (1, 2,6).

In addition, EMA's DARWIN EU (Data Analysis and Real-World Interrogation Network) project collects data from approximately 130 million patients across Europe and provides timely and reliable evidence on the safety and effectiveness of drugs (7). The project is designed to respond to scientific committees and national competent authorities by carrying out non-interventional studies, with goals to conduct 140 studies annually from 2025 onward (7).

How does RWE enhance patient-centric innovation?

Beyond mandatory safety monitoring, RWE is fundamentally tied to the industry’s push toward patient-centric and personalized therapies. Regulatory agencies are encouraging developers to gather and include patient experience data throughout a drug’s lifecycle (5). Patient perspectives are considered to be of "great value" and play a crucial, complementary role to scientific data during regulatory review (5).

By including RWE, companies can leverage patient data for adaptive regulatory pathways (8). For drug developers exploring novel therapies, RWE can be gathered from existing research or post-market drugs to help choose a drug development direction, such as investigating new cell therapies for oncology (4). RWE can help fill knowledge gaps quickly and offer tailored analyses that traditional clinical trials often cannot (2).

Prioritizing RWE generation and analysis can help pharmaceutical manufacturers ensure comprehensive safety monitoring, align with global regulatory mandates, and gain crucial insights necessary to drive the next generation of effective, patient-tailored treatments. Embracing RWE may establish a competitive advantage in a data-driven world.

Haigney, S. FDA Creates CDER Center for Real-World Evidence Innovation. 

Barton, C. Using RWD in Non-Interventional Studies. 

Haigney, S. FDA Publishes Guidance on Real-Word Data. 

Schniepp, S. J., and Siegfried S. Ask the Expert: Questions about Real-World Evidence and Supply Chain Security. 

. Sept. 25, 2025. https://www.pharmtech.com/view/ask-the-expert-questions-about-real-world-evidence-and-supply-chain-security.

Haigney, S. EMA Looks to Include Patient Perspectives in Drug Regulation. 

Haigney, S. EMA and HMA Launch Real-Word Data Catalogues. 

Haigney, S. Europe's DARWIN EU Data Program Adds Capacity. 

Challener, C. A. Personalized and Patient-Centric Administration of Oral Medicines. 

Pharmaceutical manufacturing is increasingly complex, with personalized medicine and regulatory scrutiny driving the need for real-world evidence (RWE). RWE, derived from real-world data (RWD), is crucial for drug safety, regulatory compliance, and development. It plays a vital role in post-market safety monitoring and pharmacovigilance, revealing side effects not seen in clinical trials. Regulatory bodies like the FDA and EMA are building infrastructures to support RWE integration. RWE also enhances patient-centric innovation by incorporating patient experience data, aiding in adaptive regulatory pathways and personalized therapies.

Real-world data can be utilized to ensure quality and effectiveness of drug products.

Harnessing Real-World Evidence to Future-Proof Drug Development

Ask the Expert: Commenting on Draft Regulations

Regulatory agencies, such as FDA and the European Medicines Agencies, and other industry standard setting bodies, such as the International Council for Harmonisation and the US Pharmacopeia, often publish draft versions of the guidance documents they are developing to gather feedback from the public, which includes those scientists and engineers working in the pharmaceutical industry. But who should comment and why?

“You know, there's an opportunity before regulations get approved for industry to participate and offer their comments on the regulation. This has worked in many cases where, for instance, in the US, way back in 2013, 2014, there was a proposal for metrics. And it was through the commenting period that was open to the public, where industry

was able to put forth a case to get the agency to consider some other metrics

that we thought were important, that they were not originally in the proposal,” explains Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates. “So, the way it works is anytime there's a new regulation or a change to an already existing regulation, the FDA will announce it in what we call the Federal Register. It's kind of like the daily newspaper for the government. It's that time when they open it up for comments from industry. And so, it's very important because you can change the final regulation before it becomes official by putting your comments in through this vehicle.”

“Absolutely anyone can comment,” stresses Siegfried Schmitt, PhD, is vice president, Technical at Parexel. “You don't have to be the ultimate expert. If you feel you have something to say, absolutely, you can. Now, perhaps it is advisable or sensible to not just comment as an individual but perhaps comment through your company. Perhaps your company as such is interested in providing comments.”

Both Schmitt and Schniepp also suggest commenting through a trade association, such as the Parenteral Drug Association. “I like commenting through industry associations because usually, they gather a group of experts together proposed regulation topic, And you get to hear not only your perspective voiced, but other experts' perspectives voiced,” Schniepp says. 

Click the video above to watch Sue and Siegfried answer the following question:

“I often see regulators publishing draft guidance documents for public consultation. Can I and should I comment?”

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Okay, hello, everyone. My name is Siegfried Schmitt. I'm vice president technical with PAREXEL, and I'm one of the Ask the Expert experts for the series here, and I'm Sue Schniepp, and I'm part of regulatory compliance associates, which is a subsidiary of Nelson labs, and I am Siegfried's counterpart for Ask the Expert series.

Okay. Oh, hello, Sue. Nice to see you again. Hi, Siegfried, good to see you too well.

So we got another question here for Ask the Expert series, and this is that there are several new regulations being published in draft in Europe. And of course, there are always some being published in the US as well, and the person writing in was wondering, so how can one do this? This commenting and well, is it the done thing? Because he or she feels well, perhaps this is not something that everyone should do. Can you perhaps comment on this?

Yeah, you know, there's an opportunity before regulations get approved for industry to participate and offer their comments on the regulation. This has worked in many cases where, for instance, in the US, now you're the expert on the European arena, but in the US, way back in 2014 2013 there was a proposal for metrics, and it was through the commenting period that was open to the public, where industry was able to put forth a case to get the agency to consider some other metrics that we thought were important, that they were not originally in the proposal. So the way it works is, anytime there's a new regulation or a change to already existing regulation, the FDA will announce it in the what we call the Federal Register. It's kind of like the daily newspaper for the government, and it's that time where they open it up for comments from industry. And so it's very important, because you can change the final regulation before it becomes official by putting your comments in through this vehicle.

That's very interesting. Thank you. Sue and perhaps to add, in Europe, not every regulation is open for public comment, but many are, and so as the person writing in was asking is, can anyone do this? Absolutely, anyone can comment. You don't have to be the ultimate expert if you feel you have something to say absolutely, you can now perhaps it is advisable or sensible to not just comment as an individual, but perhaps comment through your company. Perhaps your company as such, is interested in providing comments many companies do, or perhaps through an industry association like ispe, PDA, raps, you name it there. There are many out there. So perhaps so, because you have done this many times, you could say a few words why this is such a good way to comment. If you do it through an industry association.

Well, I like doing it through the industry associations because usually they gather a group of experts together on the topic, proposed topic, regulation, topic, and you get to hear not only your perspective is voiced, but other experts perspectives are voiced. So I like the broad scope information that working with a team of experts on this topic brings you, it makes the comments more robust. And I, I think the trade organizations have a certain because they're representing multiple experts, multiple companies. There's a little bit more weight kind of associated with it, from my perspective as a commenter, right rather than an individual. I'm not saying that the FDA or the regulatory authorities puts more weight in the comments of a trade organization over an individual. I'm saying that as. As a commenter, I feel there's more weight in my comments when they go in under a trade association. That's a personal feeling, though.

Well, to pick up on this Sue, particularly if you're an inexperienced person in commenting on regulations, I think it's very valuable to be part of such a group, in an industry association, because many of those who will be part of this group will have done it before, and there are certain things that regulators will simply ignore if you put things in that cannot be acted upon. So you can learn an awful lot how you can effectively influence, a regulation, a guidance, and what things are best left out. So it's a very good learning experience, and it helps one understand how, in fact, these regulations are being put together.

Yes, it puts a perspective for the the new person who might be new to this commenting game. I think we've restricted our discussion right now to regulation proposals, but there are other publications that are open for comment, such as the European Pharmacopeia or the United States Pharmacopeia, and it's important for people to understand those two have a comment period where You can influence the outcome of the work that they're doing and establishing, you know, the standards and some of the guide interpretation of guidances and how to enact those do?

They also have these expert advisory groups. I believe they're pharmacopeias.

They do. They have expert committees, both in the EU and the USP, I think that I'm not sure about the Japanese Pharmacopeia. And those advisory panels will propose the change to the Pharmacopeia, and then it will go, usually, through what they call, at least in the US, it's called the pharmacopeial forum, where it's open for review. I forget what they call it in Europe, but it's kind of similar to the same process.

Okay, yes, and perhaps, as you say, it's not just these draft regulations that are open for comment, where you can influence what will be the ultimate regulation, or how things will be regulated, because you and I, we are both members of industry associations and help them write best practice guides, yes, and these best practice guides are sometimes even cited by the agencies like FDA and Emma and so on, because they complement the regulations. Yes, not everything can be in a regulation. Certain things are better said in a guidance document, which may come from an industry association. Well,

there's also, and you're very active in PDA, as I am, and to use them, and as an example, we do publish technical reports on topics that may not quite have made it into the regulation, but are important and implementing some of this standards and expectations of regulatory authorities, and those often can be cited by the regulators, as as you said, Best Practice documents indeed. So coming back to the question that was asked of us, really, it is, it is very advisable to get involved. You do not have to be the ultimate expert, but you learn for yourself also about the processes. You learn about how regulations are being put together, and how, really, industry does have quite an influence on how these regulations will be written. So we can only encourage, I think, become part of these associations, be become an active part, not just the consumer, yes, and I think there's many more, you know, you're touching on a topic near and dear to my heart there. Siegfried, it's not only just commenting, but try to get involved. You know, if you think you have an expertise, maybe you want to put in your nomination. And for a USP expert committee or EP expert committee member. There's also American National Standards Institute. If you're in the US, you can join ANSI, or you can try to join a organization that works to develop ANSI standards. And then there's Amy, right So, and I know there's European organizations, maybe you have some of those that you but to put your name in the hat and say, I'd like to volunteer and I'd like to be on this committee is another great way to try and influence or get the best regulation out there.

And again, if you do work for a company, then your managers will be very interested in this, because it really helps you, but it also helps the company. It raises the profile, doesn't it?

Well, thank you very much. So I think we've covered this topic for today.

I agree. Thank you. Siegfried, always a pleasure to talk with you.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, Parexel, give their opinions on why those working in the pharmaceutical industry should lend their voices to draft regulations.