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From Data to Evidence: June 2024 biologit Newsletter

Welcome to our monthly newsletter: your place for the latest industry and regulatory news in the world of Pharmacovigilance and AI!


 

US: FDA Announcement -Introducing the Emerging Drug Safety Technology Program (EDSTP)


The FDA's Center for Drug Evaluation and Research (CDER) has launched the Emerging Drug Safety Technology Program (EDSTP), a program designed to enhance pharmaceutical safety evaluation through cutting-edge technologies. CDER recognises industry’s interest in dialogue around AI capabilities that advance PV, and has established the EDSTP with three goals: 


  • Serve as the central point of contact for discussion between industry and CDER on the use of AI and other emerging technologies in PV 

  • Enable knowledge management and knowledge transfer within FDA specific to the context of AI or other emerging technologies used in PV

  • Understand the context of the use of AI and other emerging technologies in PV to inform potential regulatory and policy approaches within PV


To help further these goals, CDER created the Emerging Drug Safety Technology Meeting (EDSTM) program. These meetings will provide participants with an opportunity to meet with CDER staff to discuss their research, development, and use of AI and other emerging technologies in PV.


Here at biologit, we look forward to submitting an application in line with our culture of transparency in the use of AI in PV.


For more detailed information, read the full article on the FDA's website: CDER Emerging Drug Safety Technology Program (EDSTP) | FDA


 


Europe: National pharmacovigilance (PhV) contact person updates – Human & Veterinary


On 21st May 2024, the European Medicines Agency (EMA) released updated information on the member states requirements for the nomination of a PhV contact person at a national level. This revision now only applies to human medicinal products.  The requirements for veterinary medicinal products were updated by the application of REGULATION (EU) 2019/6, Article 77(3) and they are the same for all Member States. This states that ‘The marketing authorisation holder shall designate a local or regional representative for the purpose of receiving reports of suspected adverse events who is able to communicate in the languages of the relevant Member States.’



 


UK: The Veterinary Medicines (Amendment, etc.) Regulations 2024


In the UK, The Veterinary Medicines (Amendment, etc.) Regulations 2024, which amend the Veterinary Medicines Regulations (VMR) 2013 in respect of Great Britain, are now in force as of 17 May 2024.


The new legislation came into force on 17 May 2024. The VMR set out the controls on the marketing, manufacture, distribution, possession, and administration of veterinary medicines and medicated feed. They are a critical tool to help protect animal health, public health, and the environment. The regulation is supported by a number of guidance notes aimed at providing more detail for practitioners on the implementation of the new rules. VMD will update its guidance documents on the website to reflect the new Regulations.




 


 Tech-enabled Services with biologit


At biologit, our expert team is dedicated to addressing your pharmacovigilance needs with precision and expertise. In a successful case study, we demonstrated how biologit significantly supported a clinical-stage biotech company with its literature review requirements for a Development Safety Update Report (DSUR). 

Facing the challenge of managing vast amounts of scientific literature to meet strict regulatory standards, the biotech company benefited from the advanced capabilities of the biologit platform and database.


Our sophisticated search algorithms and comprehensive database allowed us to quickly identify and analyse relevant literature, ensuring no critical information was overlooked. The biologit team provided tailored support and expert insights, completing the literature review in a fraction of the typical time. They also delivered fully compliant, detailed reports. This collaboration saved the company valuable time and resources while enhancing DSUR quality and accuracy. 

This case study underscores biologit's commitment to providing high-quality, efficient, and compliant solutions to clients.



 

Literature Monitoring in Pharmacovigilance Challenges and Opportunities


Missing safety information from the literature can lead to unsuccessful submissions and expensive inspection findings. A compliant literature monitoring process must scale with the ever-growing volume of scientific publications while maintaining comprehensive auditability. The burden on vigilance teams from this activity is significant.



Tackling these industry-wide challenges will require state-of-the-art technology which delivers robust automation, combined with novel approaches for searching the scientific literature. This white paper explores the challenges, trends and opportunities offered by new technologies to deliver efficient and compliant literature processes, and how those challenges can be met today with the advantages of the biologit MLM-AI platform.


Get our latest white paper here: biologit white paper


 

Growth in the Pharmacovigilance Market


The pharmacovigilance market is experiencing rapid growth, driven by an increasing need for drug safety and regulatory compliance across the pharmaceutical industry. This expansion is being driven by the implementation of enhanced reporting systems that allow for more efficient and accurate tracking of adverse drug reactions. Additionally, advanced data analytics enable deeper insights and faster identification of potential safety concerns, which ultimately improves the effectiveness of drug monitoring processes.


Rising awareness about pharmacovigilance among healthcare professionals and the public further reinforces the demand for comprehensive safety measures. As a result, the market is expected to continue its growth as companies continue to invest in high-quality pharmacovigilance systems to ensure patient safety and meet regulatory requirements.



 

About biologit


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biologit MLM-AI is a complete literature screening platform built for pharmacovigilance, medical device and veterinary vigilance teams. Its flexible workflow, unified global scientific database, which includes local journals and unique AI productivity features deliver fast, inexpensive, and fully traceable results for any screening needs. Teams can save up to 70% of their time and work collaboratively across departments.


biologit literature monitoring for pharmacovigilance


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