Susan Haigney

Women, scientist and discussion with tablet by glass, reading and review with results at pharma company. People, mentor and feedback with notes, application and medical research for mpox vaccine | Image Credit: ©peopleimages.com -stock.adobe.com

’s quality experts, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, got together in December 2025 to talk about one of their favorite topics: training. The pharmaceutical industry often struggles to keep up with a robust number of skilled workers. And recent developments by major pharma companies to bring manufacturing facilities to the United States have made the topic even more complex. Below is Sue and Siegfried’s response to a reader question about training.

Q. My company is building new manufacturing facilities in the US, which will require additional workforce and skill sets. What kind of training is required and how can we deliver that training?

It's exciting news to know that there are going to be new modern manufacturing facilities. I think the question on training is really fascinating. We do keep hearing there is a shortage of workers for these facilities. So, I think there's going to need to be a lot of training fast to bring workers up to date and up to speed to man these new facilities. And I think the whole concept of training has changed from internal, where we did it internally with our little PowerPoint slides and somebody watching, to more virtual. Training has undergone, in the past 20 to 30 years massive changes, and we use artificial intelligence (AI) tools. It's going to be a challenge, because skill sets are different.

We need to talk about delivery. And as you say, there are many more ways to deliver training these days than we had 10 to 20 years ago. You and I, we've been a while in this industry, but certainly we find that almost every day we learn something new, we hear something new we had no idea about, something interesting comes about. So, learning doesn't stop.

When I started in the industry, and I needed to learn all the basics, it was learning by watching, by being told by the people who have been in the industry for a while. It's not so much in the first instance about reading the books or reading the standard operating procedure, reading the instruction. It's a lot about learning from those who've done it before. So, there needs to be a mix. You can't just throw out instructions and give it to people and say, ‘Here, you read, and you understand and you sign off’. You still need some experienced workforce that holds your hand and that guides you through what needs to be done.

I think it's kind of a scary proposition right now there, because there's a couple of things for me that are going on. One is the virtual AI assistance, where you can put somebody in that virtual area, and they can practice. We saw a demo at one of our conferences, and it's pretty amazing how it picks up on your mistakes. I think that's one way of training. I don't know how many companies can afford that, but the scary part to me is there's a lot of different companies jumping into this arena of training, and I'm not so sure that we have a lot of training associated with colleges and universities now.Do the universities have the extra, long-term expertise?

These are new, sophisticated pieces of equipment going into drive the production of these advanced therapeutic medicinal products, and I don't know that everybody jumping into the training game is qualified. So, how do we figure out who's qualified, who's not, and make the best recommendations to, you know, get the most from these activities going on?

 There are a lot of providers of training, and you mentioned universities, colleges, and I'm aware that quite a number these days are collaborating with industry all industry associations, be it the Parenteral Drug Association, the International Society for Pharmaceutical Engineering, or others. And as part of this collaboration, I know that some of these institutions have established proper clean rooms and have modern equipment in there, so you can practice hands on, and we're coming back to this point here. Yes, you can learn an awful lot by watching a video, maybe even on YouTube, but it's never exactly the same as if you are gowned up in the room, and you have to behave in the right way. You have to act in the right way. And perhaps coming back to what you said, once you see yourself doing something, you're suddenly surprised. Did I really do that? For that, you don't need very sophisticated equipment. A video camera does perfectly fine. Training should, if possible, also have this feedback loop where either someone observes and gives you feedback. But it's much more impressive if you can see it on the video, and you see for yourself where you slipped up in your process.

I also think companies should take advantage of the factory acceptance training that many of the manufacturers of the equipment offer, because that's a way to get to utilize or to see the equipment as it's being built, and kind of play with it before it gets installed. What do you think about that?

 Well, I think it's not just the equipment on the shop floor, but also the manufacturing and laboratory equipment. When you think of some of the new analytical instruments, they are really tricky and require a lot of skills to operate correctly. And again, as you say, there are lots of providers that offer these training courses is hands-on courses, and absolutely, what we are saying is training in-house, definitely, very important, but it's unlikely to suffice. There needs to be other training elements, like external training, training with suppliers, etc. It's a mix of training we suggest here.

I wonder if we look at our workforce now, we have to look at them in a different way and get them different skills. You know, the operator is no longer an operator. He's like the pilot of a sophisticated plane in a way, right? The laboratory people aren't just doing the simple high-performance liquid chromatography that came in 1980. The lab person is working with these really sophisticated, sensitive pieces of equipment. And we need to have the quality assurance professional who has to have skill sets to be able to interpret what the data that's coming in. And we've got AI out there on the floor collecting data, too. We have artificial intelligence, sophisticated equipment, new skill sets, so how do we bring people up to speed on that? I mean, it's a daunting task, in my opinion, how do we measure that they've gotten through this training the skill sets to be able to do the job in this new environment?

 Well, this reminds me of the old days when you did a lot more mechanically and by hand. And for example, in formulation, you would often employ bakers, people from a profession where you had to mix things, where they were used, to be precise, with weighing in and mixing consistently and so on.

And you're absolutely right. These days we have so much more automation. So again, it's unlikely that you can find all the skilled workforce on the market who have all the training, who've worked in this environment before. So you will need to train up persons who come from a different environment, from a different profession, and because there is so much automation, perhaps this is where their skills in computer science may be the ideal starting point to get them trained up in using, as you say, a highly sophisticated analytical system or manufacturing system. What you need to look for is, what are transferable skills? Because there isn't just a huge workforce out there that you can just bring into all these facilities and start up from day one. We will need to find transferable skills and skills that are appropriate for the modern facility.

Articles

The pharmaceutical industry faces challenges in training a skilled workforce for new US manufacturing facilities. Training has evolved from traditional methods to include virtual and AI tools, but the need for experienced mentors remains crucial. Universities and industry collaborations offer hands-on training, but the quality of training providers varies. Companies should leverage factory acceptance training and external courses to supplement in-house training. The workforce requires new skill sets to operate sophisticated equipment and interpret data, necessitating a focus on transferable skills and comprehensive training strategies.

Pharmaceutical Technology®’s quality experts, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel discuss how pharmaceutical manufacturing training has evolved over the years and how the influx of new facilities is demanding a skilled workforce.

Onshoring Requires a Plan for Training 

Integrated Digital Workflow Essential in 2026

After a year of change that included geopolitical shake ups, tariffs, and travel restrictions, André Cerbe, CEO of Schlafender Hase, sees artificial intelligence (AI) and digital workflows as tools for pharmaceutical manufacturers to be successful in 2026.

“I think it's important to mention that the pharmaceutical industry hasn’t had the easiest year, but what we've seen with our customer base is a strive for digitalization,” Cerbe says. “Some who have not digitalized their current workflow are already looking into AI.”

Cerbe says an end-to-end workflow, especially within regulatory departments, creates a more robust, agile landscape that support both the company and the greater pharmaceutical industry.

“While in the past, many projects have been a bit siloed,” explains Cerbe. “I see more and more integration of different tools, regulatory information management systems, artwork management systems, and other tools like proofreading tools or medical writing tools and research tools. A lot of pharmaceutical companies and regulatory departments are asking whether they should look for a one size fits all solution, or should they go with best-in-class providers for different segments? My recommendation is to find the best [tools] in class, integrate them well across the work stream, and reuse a lot of these things available in the industry to your best knowledge and with the best technology, because digitalization across countries, across different sites and time zones, is so important. [Digitalization is] facilitated by well-integrated workflows, and software frees up a lot of capacity within regulatory departments and speeds up time to market.”

is Managing Director of Schlafender Hase. He brings extensive experience in MedTech, Healthcare, and Private Equity to the business and has a proven track record of successfully developing and growing companies. Previous roles include investment director at Westlake Partners, Managing Director at AURA Health technologies and Managing Director at SOMATEX Medical Technologies where his strategic vision played a pivotal role in steering these organizations towards sustained success.

Videos

André Cerbe, CEO of Schlafender Hase, spoke with Pharmaceutical Technology® about the disruptions the pharma industry faced in 2025 and how digital workflows will be key for success in 2026.

Syringe and vaccine with European flag | Image Credit: ©peterschreiber.media -stock.adobe.com

 in December 2025 that it has reached an agreement with the European Commission (EC) and the Council of the European Union to move ahead with revising the pharmaceutical policy framework in the EU (1). The European Medicines Agency (EMA) has stated that it is looking forward to using the changes to streamline procedures (2, 3).

But how will the revised legislation potential impact the industry, particularly for innovation and market exclusivity? 

, a partner at Morgan Lewis, to get her perspective on what the changes, and the process for putting them in place, will mean for pharmaceutical companies.

PharmTech: What do you see as the most significant change in the new agreed-upon revamped EU medicines policy?

The most highly contested and most discussed element of the reform has always been the regulatory protections for innovative medicinal products. Under the current “8 + 2 +1” system, a new product receives eight years of data protection, followed by two years of marketing protection, plus an additional year for the authorization of a new indication under certain conditions. Whether this represents the correct balance between incentivizing innovation and enabling generic/biosimilar entry has long been debated, and amending these rules was a key part of the Commission’s original proposal. 

Under the agreement, the baseline period of protection will remain at eight years of data protection, but market protection will be a standard one-year period. However, this can be extended up to a maximum of three years (with 11 years of protection overall) if certain conditions are met, including if the product addresses an unmet medical need, is a new active substance fulfilling certain conditions, or if the company obtains an authorization for a new therapeutic indication.

Linked to this, the supply obligations have been controversial. The original proposal was focused on ensuring that medicines are available across all member states, and various mechanisms were proposed during the legislative process for how this should take place. Under the agreement, EU countries ‘have the power’ to ‘require’ companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs, and if this does not happen, companies may lose market protection in the relevant member state.

How will the market exclusivity changes impact drug development and market competition?

The key issue will be the uncertain and variable protection periods introduced by the new regime. The agreement does seem to address some concerns raised by the industry and is more favorable than the initial proposal from the Commission. However, it does still mean a reduction to the current period of protection, although with the potential for extensions. A key question will be how these extensions operate, including what steps should be met and how companies can evidence each of the criteria. This adds complexity and uncertainty to the current regime, and it is unclear how many products will be able to benefit from the extensions available. Companies should factor this uncertainty into their development and investment plans, and the impact of that is not yet known.

Similarly, the access obligation will need to be reviewed in the final text to understand how this will work in practice and what this means for the supply of the product in member states where market protection is still in place. Enforcement of market protection is complex, and having different periods of protection in different member states will only add to the complexity.

While this regime has been presented by the EU institutions as a balance between the innovative and generic industries, this in fact leads to uncertainty for both. Generic-drug companies make development and launch plans a number of years before the expiry of the protection period for the reference product. Those plans might have to be amended if protection periods are reduced or extended.

How does the new policy on orphan drug exclusivity impact the development of innovative medicines for unmet needs?

For orphan protection, the current period of orphan exclusivity is 10 years. Under the agreement, the baseline period will be nine years, with 11 years of protection for a new class of ‘breakthrough’ products. Again, the EU institutions were keen to emphasize that this represents a balance between reduced base period of protection on the one hand, but rewarding innovation with a longer period of protection for ‘breakthrough’ products on the other. The definition will be crucial in understanding how attainable the additional years of protection will be and whether this operates as an incentive to develop products for unmet medical needs.

In addition, during the legislative process, all three EU institutions recommended extending the concept of the global marketing authorization to orphan products, so that an active substance only receives one period of protection that can be extended under certain conditions, rather than the current system where separate exclusivities apply for each orphan condition. In addition, generic applicants would be able to make applications two years before the expiry of orphan exclusivity. It is not clear from the press releases whether these proposals have been maintained, and if so, in what form. In practice, both of these proposals are likely to reduce the protection for innovative products, and so questions will remain about whether the agreed incentives are sufficient to support the development of products for unmet needs.

How will the EU changes impact how drug manufacturers submit products for market authorization?

The changes will lead to a lot of additional strategy planning for companies to consider how the new protection periods and procedures might impact development. Companies may need to revisit their filing strategies in light of the possibilities for extensions. For some products, it might be beneficial to speed up applications so they can be made under the current rules, while for others, it might be beneficial to delay applications to take advantage of the changes. Companies may also need to adjust launch sequencing to avoid the risk of a reduction in market protection. This will likely impact all companies, but in particular small and medium-sized companies that may not have operations in all countries.

The agreement also puts in place procedural and structural reforms intended to modernize the regulatory framework and foster innovation. These include a shorter assessment time (reduced from 210 to 180 days), streamlined EMA processes and structures, and the use of regulatory sandboxes to test innovative medicines that cannot be developed under current rules. The amendments will also provide additional ways for companies to engage with EMA, including extended scientific advice with health technology assessment bodies or medical device expert panels. All of these could be positive changes to EMA procedures, but until the full text is available, it is unclear whether these will impact how manufacturers approach development and interactions with EMA, and whether they lead to meaningful advances for patients.

European Parliament. Deal on Comprehensive Reform of EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation

EMA. EMA Welcomes Political Agreement on New EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation

EMA. Emer Cooke, EMA’s Executive Director: 2025 Achievements in Medicine Regulation. Press Release. Dec. 19, 2025. 

https://www.ema.europa.eu/en/news/emer-cooke-emas-executive-director-2025-achievements-medicine-regulation

The European Parliament, European Commission, and Council of the European Union have agreed to revise the EU pharmaceutical policy framework, impacting innovation and market exclusivity. The new policy maintains the eight-year data protection but reduces market protection to one year, extendable to three years under specific conditions. Orphan drug exclusivity is reduced from ten to nine years, with potential extensions for breakthrough products. These changes introduce uncertainty in protection periods, affecting drug development strategies. Procedural reforms aim to modernize the regulatory framework, including shorter assessment times and streamlined EMA processes.

How will plans to rework medicines legislation in the European Union impact drug development, innovation, and market exclusivity?

Innovation and Market Exclusivity in the EU

Concept of EMA European Medicines Agency. Drugs evaluation and quality control department. | Image Credit: ©wladimir1804 -stock.adobe.com

On Dec. 19, 2025, Emer Cooke, executive director of the European Medicines Agency (EMA), published highlights of the agency’s accomplishments in 2025, which marked three decades since its inception. Among EMA’s successes was the recommendation of 104 new drugs during the year, with almost 40% containing a new active substance (1).

Chief among the 2025 events, according to Cooke, is the 

 between the European Commission (EC), the European Parliament, and the Council of the European Union to revamp pharmaceutical legislation (2), 

How will EMA shift to address new legislation?

“The agreement on the new pharmaceutical legislation is a historic milestone for medicines regulation in Europe and for patients across the EU, a golden opportunity to become more agile and efficient,” Cooke stated in the release (1).

Cooke said the agency will be using the opportunity provided by the legislation to focus efforts in three areas. The agency will be “reimagining” how it works, and Cooke plans to adapt systems to better handle scientific and technological advancements. Early development and innovation will be supported to enable quicker market authorizations. Investments will also be made in staff and network workforce to build capacity and capabilities.

What drug recommendations were made by EMA?

EMA recommended 104 new drugs in 2025, 40% of which were new active substances. These included the first treatment to delay the onset of stage 3 type 1 diabetes in adults and children aged eight and older. The first treatment for Duchenne muscular dystrophy was also recommended for patients aged six and older who can walk. Europe also got its first Chikungunya vaccine for adolescents aged 12 and older.

EMA also recommended changes to the use of the antibiotic azithromycin to reduce the chance of antimicrobial resistance. Plus, measures were recommended to minimize the risk of suicide with finasteride and dutasteride, which is used to treat androgenetic alopecia in men.

 in January to provide a coordinated system and framework for how the agency works with national authorities and actors in the European Union to ensure that the supply chain of drugs is robust.

The agency coordinated with the European Commission and other regulatory bodies to communicate across channels and worked with content creators to promote safe and responsible use of GLP-1 drugs. “In an environment where misinformation spreads faster than facts, we must embrace innovative approaches to communication and stakeholder engagement,” Cooke stated.

“Europe has always been a place where ideas spark change. It has world-class science and world-class expertise. We need to protect and promote these strengths,” she continued. “We need a Europe where facts matter, innovation thrives, and collaboration wins. The future is ours to shape—let’s shape it together, with science.”

EMA. Emer Cooke, EMA’s Executive Director: 2025 Achievements in Medicine Regulation. Press Release. Dec. 19, 2025. 

In 2025, the European Medicines Agency (EMA) celebrated its 30th anniversary by recommending 104 new drugs, with 40% featuring new active substances. A significant milestone was the agreement to revamp EU pharmaceutical legislation, enhancing EMA's agility and efficiency. The agency plans to focus on reimagining operations, supporting early development, and investing in workforce capabilities. Notable drug recommendations included treatments for type 1 diabetes, Duchenne muscular dystrophy, and a Chikungunya vaccine. EMA also launched the European Shortages Monitoring Platform to strengthen drug supply chains and collaborated to promote responsible drug use.

Executive Director Emer Cooke presents EMA’s achievements for the year.

EMA Director Sees Legislation Revamp as Highlight of 2025

Ask the Expert: Training for a Skilled Workforce

Geopolitical stressors, such as trade policies put in place by the Trump administration in the United States, have pushed some pharmaceutical companies to invest in moving production and building new facilities in the US (1). With expansion, however, comes the need for qualified personnel to run operations in these manufacturing facilities.

But the industry has been struggling in recent years in obtaining the personnel with the proper skill sets to meet demand. And because pharmaceutical development and manufacturing are regulated industries, training personnel is crucial to ensure safe and effective medicines reach the patients that need them. So how can pharma companies ensure their staff, new and current, are up to speed on the latest tools, processes, and regulations?

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt, PhD, VP Technical at Parexel, delve into the complexity of training in this episode of Ask the Expert.

“I think the question on training is really fascinating, says Schniepp. “We do keep hearing there is a shortage of workers for these facilities. I think there's going to need to be a lot of training fast to bring workers up to date and up to speed to man these new facilities. And I think the whole concept of training has changed from internal, where we did it internally with our little PowerPoint slides and somebody watching to more virtual training has undergone in the last 2030, years, massive changes, and we use AI tools.”

“We need to talk about delivery [of training],” Schmitt stresses. “There are many more ways to deliver these days than we had 1020, years ago. You and I, we've been a while in this industry, but certainly we find that almost every day we learn something new, we hear something new, we had no idea about something interesting comes about. So, learning doesn't stop. And the other thing that I certainly look back to when, when I started in industry and I needed to learn all the basics, it was learning by watching, by being told by the people who have been in the industry for a while. So, it's not so much in the first instance about reading the books or reading the standard operating procedure, reading the instruction. It's a lot about learning from those who've done it before. So there needs to be a mix, I'd say. You can't just throw out instructions and give it to people and say, ‘here you read and you understand and you sign off’. You still need some experienced workforce that holds your hand and that guides you through what needs to be done.”

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

“My company is building new manufacturing facilities in the US, which will require additional workforce and skill sets. What kind of training is required and how can we deliver that training?”

Cole, C. How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains. 

https://www.pharmtech.com/view/how-100-pharmaceutical-tariffs-will-impact-domestic-manufacturing-and-supply-chains

Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates, a Nelson Labs company

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

Siegfried Schmitt, PhD, VP Technical at Parexel

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.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), and Siegfried Schmitt, Parexel, tackle the ever-growing problem of having a properly trained workforce with a variety of needed skill sets. 


 (EMA) positively responded to the news that the European Commission (EC), the European Parliament, and the Council of the European Union have reached an agreement to comprehensively reform pharmaceutical legislation in the EU (1). The 

 to move forward with a 2023 proposal by the European Commission was announced on Dec. 11, 2025 (2). The reform will grant regulatory data and market protection for a period of eight years with additional years given to drugs developed for unmet needs and other considerations.

According to EMA, with this reform, the development and authorization of drugs will be modernized and procedures will be simplified. Current regulations that will be impacted will include Regulation 726/2004 and Directive 2001/83/EC, Regulation 1901/2006 and Regulation 141/2000/EC (medicines for children and rare diseases, respectively), and the advanced therapy medicinal products (ATMP) Regulation 1394/2007.

“Today marks a historic milestone for European medicines regulation and for patients across the EU,” said EMA’s Executive Director Emer Cooke in a press release (1). “The revamp of the pharmaceutical legislation will enable EMA and the European medicines regulatory agencies network to become more agile and efficient while upholding the highest standards of scientific rigor.”

“By simplifying procedures, embracing digitalization, and rationalizing our use of scientific resources, we will be better positioned to support innovation and ensure that promising new treatments reach patients faster,” Cooke added in the release (1). “The new legislation also provides us with the tools to deliver on our network strategy to 2028 and address the major public health challenges of the future, from antimicrobial resistance to emerging health threats.”

How will the reform impact EMA procedures?

The agency’s committee structure will be made leaner and will be complemented by increased patient and healthcare professional representation. This includes the Committee for Human Medicinal Products and the Pharmacovigilance Risk Assessment Committee.

Assessment times will be reduced from 210 days to 180 days, freeing up scientific resources for pre-authorization support for drug companies. Digital solutions will include the requirement for drug applicants to submit market authorization applications in electronic formats and provide product information in electronic form.

Possibly one of the most interesting changes is that market authorization of a drug will be valid by default for an unlimited period. The agency states this will avoid unnecessary administrative burden surrounding renewals, unless required for safety reasons determined by EMA’s scientific committees.

How will these changes improve innovation?

The agency states that. with these reforms, it will be able to offer extended scientific advice with health technology assessment bodies and strengthen support for drugs under priority medicine designation. EMA will also be able to request that the EC establish a regulatory sandbox to test requirements for innovative medicines that cannot be developed under the current rules.

Adapted frameworks may also be created for certain non-standard drug categories, and process inefficiency improvements for pediatric medications can be established, such as the formalization of a new process from iterative pediatric investigation plans.

The agreement is subject to formal approval by the European Parliament and the Council and may take months to years to be finalized. During that time, EMA will work with the EC and EU Member States to develop guidance documents to help drug developers comply with the new rules. EMA will be keeping stakeholders informed as the process goes forward and has plans for an information repository web page available for pharmaceutical companies.

EMA. EMA Welcomes Political Agreement on New EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

European Parliament. Deal on Comprehensive Reform of EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. 

The European Medicines Agency (EMA) has endorsed a significant reform of EU pharmaceutical legislation, agreed upon by the European Commission, European Parliament, and the Council of the European Union. This reform aims to modernize drug development and authorization, streamline procedures, and enhance innovation. Key changes include extended regulatory data protection, reduced assessment times, and digitalization of application processes. The reform also introduces unlimited market authorization validity, unless safety concerns arise. Formal approval is pending, and EMA will collaborate with stakeholders to ensure compliance with the new regulations.

The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union. 