Anni Svala Archives - European Industrial Pharmacists Group (EIPG)

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

How AI is Changing the Pharma Industry and the Industrial Pharmacist’s Role

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Svala Anni, Favard Théo, O´Grady David

The pharmaceutical sector is experiencing a major transformation, propelled by groundbreaking drug discoveries and advanced technology. As development costs in the pharmaceutical industry exceed $100 billion in the U.S. in 2022, there is a pressing need for innovative solutions to accelerate drug development. The urgency stems from a renewed focus on novel approaches, driven by the complexities of advanced therapeutic modalities like mRNA, CGT, and synthorins. This blog delves into the influence of Artificial Intelligence (AI) on overcoming the unique hurdles within the manufacturing domain of the pharmaceutical industry. It specifically emphasizes the crucial partnership between AI and human expertise, shedding light on the vital role of industrial pharmacists in optimizing manufacturing processes.

The demands for precision, quality, and compliance in pharmaceutical manufacturing present challenges, notably in managing rising costs and intricate logistical processes. The adoption of various AI technologies, including generative AI (GenAI), represents a strategic shift, aiming to augment human capabilities while automating routine tasks and facilitating knowledge transfer in the ever-evolving landscape of pharmaceutical production

The fourth industrial revolution is upon us with the development of cyber physical systems and the fifth industrial revolution is on the horizon with the advancement of artificial intelligence (AI) in partnership with humans to enhance workplace processes. The factory of the future is here with digitalization, AI, Big data, robotics and advanced manufacturing becoming the norm rather than the exception in the pharmaceutical industry.

GenAI excels in promoting collaboration while surpassing traditional task automation. It is key in transmitting complex knowledge crucial for maintaining quality, compliance, and safety in pharmaceutical manufacturing. AI empowers experts to document processes using everyday devices, transforming this raw data into straightforward, visual instructional guides.

The pharmaceutical industry confronts distinct manufacturing challenges, including complex processes and rigorous regulatory standards. AI can offer several innovative and compliant solutions. In addition, AI platforms swiftly update training materials, creating dynamic learning environments that keep the workforce informed about the latest developments. These platforms are redefining roles by taking over mundane tasks, thereby freeing human workers to focus on more strategic and creative roles. Furthermore, AI guarantees uniform training across global operations, ensuring consistent processes and fostering global standardization.

Combining humans and AI creates a powerful team that may benefit everyone. AI helps make learning experiences unique for each person, fitting their own way of learning. It also makes it easy for people to get the information they need anytime, thanks to the latest tech advancements. AI is great at helping people from different cultures and who speak different languages work together better. It can give feedback right away, so mistakes don’t spread. Plus, AI holds onto valuable knowledge, reducing the chance of losing important information when people leave or retire. Together, all these benefits show how AI can make a big, notable change also in the pharmaceutical field.

AI – Shaping the Future of Pharmaceutical Industry

AI is transforming the pharmaceutical landscape, particularly in areas vital to industrial pharmacists, such as manufacturing, quality control, and distribution. These professionals play a pivotal role in skillfully integrating AI, serving as the human-in-the-loop to enhance efficiency and ensure safety in pharmaceutical operations.

AI elevates the manufacturing process, forecasts maintenance needs, and sharpens quality control. Industrial pharmacists are pivotal in deploying these AI-driven techniques, ensuring that operations are not only effective but also meet high-quality standards and regulatory requirements.

The Role of Industrial Pharmacists

Industrial pharmacists are essential contributors to this technological revolution, actively collaborating with data engineers and scientists. They play a pivotal role in ensuring regulatory compliance, upholding product quality, and leveraging AI to enhance drug development processes, inventory management, and distribution. Industrial pharmacists:

  • are essential in incorporating AI into manufacturing workflows.
  • ensure AI tools align with regulatory requirements and uphold product quality.
  • utilize AI to accelerate and economize the drug development process.
  • leverage AI for more effective inventory and distribution management.
  • analyze data generated by AI systems for informed decision-making in production and quality control.
  • ensuring the quality of pharmaceutical products, they play a crucial role in safeguarding patient safety.
  • leverage AI to identify eco-friendly manufacturing practices, contributing to sustainable pharmaceutical production.

Risks and Challenges

Using AI in the pharmaceutical environment involves navigating risks such as ensuring data privacy and security, maintaining regulatory compliance, addressing biases and ethical concerns, and dealing with the quality and reliability of data. Additionally, there are challenges related to intellectual property issues, integration with existing systems, scalability and maintenance, and dependence on external vendors. To effectively leverage AI benefits while minimizing these risks, a comprehensive strategy encompassing robust data governance, ethical AI practices, ongoing regulatory engagement, and careful technological and organizational change management is essential.

Conclusion

The pharmaceutical industry stands on the brink of a transformative era, driven by the profound potential of AI to reshape its landscape. The key to unlocking this potential lies in the proactive involvement of industrial pharmacists, who are urged to assume a more strategic and leading role in steering innovation.

Traditionally perceived as followers, industrial pharmacists now face a pivotal moment to transition into drivers of change. This isn’t merely a shift in perception; it is a call to action. The integration of AI offers a unique opportunity for pharmacists to shape the future of pharmaceutical care actively and courageously.

In this evolving landscape, industrial pharmacists are not just guardians of compliance but architects of efficiency, adaptability, and innovation. Collaborating seamlessly with AI technologies, they hold the power to propel the industry forward. Despite certain challenges, this collaboration looks promising – it isn`t just compliant and efficient but also dynamic and inventive.

The call to action is clear – pharmacists, especially those in industrial roles, are not merely spectators in this technological revolution; they are the forerunners, charting a course towards a more responsive and innovative pharmaceutical future.

References:

Artificial trends: intelligence in the pharmaceutical industry: analyzing, innovation, investment and hiring

Insights to the Industrial Pharmacist role for the future: A concept paper from EIPG Advisory Group on Competencies, vol 2, 2023

Pizoń J, Gola A. Human–Machine Relationship—Perspective and Future Roadmap for Industry 5.0 Solutions. Machines. 2023; 11(2):203.

Zheng, S. (2023, Nov. 2). “Empowering the pharma workforce.” Pharma Manufacturing.

Contact for further information:
Anni Svala, Vice-President for European Affairs, European Industrial Pharmacists Group, [email protected]


Academic Research in industrial pharmacy field

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By Anni Svala

Dear Colleague,

As a part of our University of Helsinki Industrial Pharmacy specialization studies we are conducting a research of remote audits.

The purpose of our academic study is to gather information and knowledge about remote audits together with the company practices and remote audit policies. The study consists of an audit survey created with the Webpropol® survey platform.

On our studies, we research both the Auditor and the Auditee experiences and points of view.

The supervisor of the study is Professor Anne Juppo from University of Helsinki, Faculty of Pharmacy (e-mail: [email protected]).

All responses are anonymous and the respondents cannot be recognized by the survey results.

In case you have experience in both Auditor and Auditee perspective, we would highly appreciate it if you could answer the survey twice, once for each point of view.

The survey material is solely collected for the study purposes to which this invitation to response also includes. All study material is archived and kept on our personal computers for 6 months after the study publication, after which the material is destroyed.

Answering the electronic survey will take approximately 15-20 minutes. Link to the survey is at the end of this letter. This survey has been sent as a sampling to Auditors and quality professionals working in pharmaceutical companies and wholesale distribution companies.

Our study will be completed during summer 2022 and it will be published in an academic journal. Our research is also stored in the publication archive of the University of Helsinki, where it is freely readable.

Please fill in your contact information via separate link after answering the survey questions if you wish to receive the publication when available.

The survey is open until 17 April 2022.

If you have any questions regarding our research feel free to contact us by email.

Link to the survey: 

https://link.webropol.com/s/Uni-Helsinki-audit-survey2022

Our utmost gratitude for giving a moment of your time to answer to our survey.

Kind regards,

Terhi Liukko & Anni Svala

University of Helsinki, Faculty of Pharmacy

Industrial Pharmacy Specialization students
[email protected], [email protected]