Latest news with #pharmacovigilance
Medscape
11-07-2025
- Health
- Medscape
EMA Questions Valproate Prescribing Restrictions for Men
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has announced it is assessing new data on the potential risk of neurodevelopmental disorders (NDDs) in children born to men treated with valproate during spermatogenesis. The announcement comes after controversial new precautionary measures for the treatment of male patients with valproate medicines were imposed in January 2024. The cautionary approach to valproate — a medicine used to treat epilepsy, bipolar disorders, and in some countries migraine — came about as a result of a post-authorization safety study (PASS) funded by a consortium of marketing authorization holders for valproate and related substances. After examining the results, PRAC recommended that valproate treatment in male patients be started and supervised by a specialist in the management of epilepsy, bipolar disorder, or migraine. It also said that valproate treatment of male patients should be reviewed regularly to consider whether it remains the most suitable treatment, particularly if the patient is planning to conceive a child. Original Study Suggests Risk PASS was a population-based retrospective study that used data from multiple Scandinavian registry databases in Denmark, Norway, and Sweden, together with other available information, to evaluate the association between paternal exposure to valproate and the risk of NDDs in offspring, including autism spectrum disorders, intellectual disability, communication disorders, attention deficit/hyperactivity, and movement disorders, as well as congenital abnormalities. The results suggested a potential increased risk to children born to men treated with valproate during the 3 months before conception. This led PRAC , and later the UK's Medicines and Healthcare products Regulatory Agency, to recommend precautionary measures for the treatment of male patients with valproate medicines. These measures were in addition to restrictions already in place since 2018 to avoid valproate exposure in pregnancy due to evidence of an increased risk of malformations and developmental problems. Second Study Casts Doubt At that time, the committee acknowledged that the PASS data had limitations but concluded that the potential risk warranted informing patients and healthcare professionals. However, a study published in JAMA in June 2024 using a subset of the same data cast doubt on the PASS findings. That study aimed to replicate the PASS results using the nationwide Danish data sources that had been used in PASS. In this later study, 1336 children among the total cohort of 1,235,353 children had been born to fathers who filled prescriptions for valproate during spermatogenesis. No association was found between paternal valproate use and risk of major congenital malformations or NDDs, the researchers said. The researchers highlighted that the PASS results stemmed from an observational study report prepared by contract research organization IQVIA. "We were unable to replicate the IQVIA study results," they said. Latest Study Shows No Risk The same research team subsequently published a research letter in JAMA in May 2025, in which they said that they had access to only limited information about the IQVIA study at the time of their 2024 report. Following publication of the detailed IQVIA report, the team conducted analyses to explore the impact of methodological choices and definitions used in that study. "Paternal valproate exposure was not associated with an increased risk of NDDs," they concluded. This was the case for the composite endpoint of all NDDs and "remained robust" across analyses of specific NDDs, expanded definitions of NDDs, valproate dose, time trends, polytherapy, and analyses restricted to fathers with epilepsy. PRAC said that, in the light of this latest study's inability to replicate the signal for NDDs in children with paternal valproate exposure and a more recent systematic review from Australia that also showed "no clear evidence for an adverse impact of paternal antiseizure medication use on offspring outcomes," the committee has initiated a signal procedure to understand the difference in the findings across the studies. It has also requested further information and analysis from valproate marketing authorization holders. The EMA will communicate further when more information becomes available, it said.
Yahoo
16-06-2025
- Business
- Yahoo
Dr. Jethro Ekuta Joins BP Logix Life Sciences Strategic Advisory Board
Global regulatory leader brings decades of experience to guide the next generation of medical affairs automation. SAN DIEGO, June 16, 2025--(BUSINESS WIRE)--BP Logix, a leading provider of AI-enabled medical affairs automation technology, is proud to announce the appointment of Dr. Jethro Ekuta to its Life Sciences Strategic Advisory Board. Dr. Ekuta is the Chair of the Board of Directors for the Regulatory Affairs Professionals Society (RAPS) and currently serves as Chief Regulatory & Safety Officer at Ascendis Pharma. With over 30 years of experience in regulatory affairs and pharmacovigilance, Dr. Ekuta brings a deep understanding of global compliance, regulatory strategy and innovation in drug development. He has held senior leadership roles at organizations including Ascendis Pharma, Alexion (AstraZeneca Rare Disease), Horizon Therapeutics (Amgen), Johnson & Johnson, Genzyme (Sanofi), Bristol-Myers Squibb, Pfizer and the U.S. Food and Drug Administration (FDA). "We are honored to welcome Dr. Ekuta to our Life Sciences Strategic Advisory Board," said Girish Pashilkar, CEO of BP Logix. "His regulatory insight and leadership will be instrumental as we continue to expand our footprint in the life sciences sector and support teams navigating increasingly complex review and approval processes." "I've spent my career working to improve regulatory systems and processes within the pharmaceutical and biotech industries," said Dr. Ekuta. "I believe BP Logix is uniquely positioned to help life sciences organizations streamline compliance, reduce risk and move faster without compromising integrity. I'm excited to contribute to the company's mission and support its growth in this critical space." In his advisory role, Dr. Ekuta will provide strategic input across marketing, product, and customer engagement initiatives. His appointment is part of a broader effort by BP Logix to deepen its alignment with industry leaders and further tailor its solutions to the evolving needs of life sciences organizations. About BP Logix BP Logix helps medical affairs and regulatory teams at life sciences organizations streamline complex review and approval workflows. Its flagship solution, PubPro, simplifies the publication process, while the broader Approvia platform supports use cases such as MLR reviews, clearance systems, medical information requests and IIS evaluations. With a focus on configurability, compliance and speed, BP Logix empowers teams to reduce risk, improve collaboration and bring high-quality treatments to market faster. To learn more about BP Logix and its work in life sciences, visit View source version on Contacts Media contact: Catie Leary,
Associated Press
16-06-2025
- Business
- Associated Press
Dr. Jethro Ekuta Joins BP Logix Life Sciences Strategic Advisory Board
SAN DIEGO--(BUSINESS WIRE)--Jun 16, 2025-- BP Logix, a leading provider of AI-enabled medical affairs automation technology, is proud to announce the appointment of Dr. Jethro Ekuta to its Life Sciences Strategic Advisory Board. This press release features multimedia. View the full release here: Dr. Jethro Ekuta, member of the BP Logix Life Sciences Strategic Advisory Board. Dr. Ekuta is the Chair of the Board of Directors for the Regulatory Affairs Professionals Society (RAPS) and currently serves as Chief Regulatory & Safety Officer at Ascendis Pharma. With over 30 years of experience in regulatory affairs and pharmacovigilance, Dr. Ekuta brings a deep understanding of global compliance, regulatory strategy and innovation in drug development. He has held senior leadership roles at organizations including Ascendis Pharma, Alexion (AstraZeneca Rare Disease), Horizon Therapeutics (Amgen), Johnson & Johnson, Genzyme (Sanofi), Bristol-Myers Squibb, Pfizer and the U.S. Food and Drug Administration (FDA). 'We are honored to welcome Dr. Ekuta to our Life Sciences Strategic Advisory Board,' said Girish Pashilkar, CEO of BP Logix. 'His regulatory insight and leadership will be instrumental as we continue to expand our footprint in the life sciences sector and support teams navigating increasingly complex review and approval processes.' 'I've spent my career working to improve regulatory systems and processes within the pharmaceutical and biotech industries,' said Dr. Ekuta. 'I believe BP Logix is uniquely positioned to help life sciences organizations streamline compliance, reduce risk and move faster without compromising integrity. I'm excited to contribute to the company's mission and support its growth in this critical space.' In his advisory role, Dr. Ekuta will provide strategic input across marketing, product, and customer engagement initiatives. His appointment is part of a broader effort by BP Logix to deepen its alignment with industry leaders and further tailor its solutions to the evolving needs of life sciences organizations. About BP Logix BP Logix helps medical affairs and regulatory teams at life sciences organizations streamline complex review and approval workflows. Its flagship solution, PubPro, simplifies the publication process, while the broader Approvia platform supports use cases such as MLR reviews, clearance systems, medical information requests and IIS evaluations. With a focus on configurability, compliance and speed, BP Logix empowers teams to reduce risk, improve collaboration and bring high-quality treatments to market faster. To learn more about BP Logix and its work in life sciences, visit View source version on Media contact: Catie Leary, [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: TECHNOLOGY HEALTH TECHNOLOGY SOFTWARE NETWORKS INTERNET MANAGED CARE HEALTH DATA MANAGEMENT ARTIFICIAL INTELLIGENCE SOURCE: BP Logix Copyright Business Wire 2025. PUB: 06/16/2025 07:00 AM/DISC: 06/16/2025 06:59 AM
Yahoo
04-06-2025
- Business
- Yahoo
Global Regulatory Requirements for Drug Safety & Pharmacovigilance Certification Program: Navigating Product Safety Regulations in the US and EU Course (ONLINE EVENT: August 5, 2025)
Enhance your pharmacovigilance operations with our comprehensive training course tailored for pharmaceutical and biologic companies. Gain insights into US, EU, and UK drug safety regulatory requirements, risk management, and reporting processes. Ensure compliance, boost consumer confidence, and protect your brand image. Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "Global Regulatory Requirements for Drug Safety & Pharmacovigilance Certification Program" training has been added to offering. This training course is designed to give pharmaceutical and biologic companies operating in the US and EU an introduction to product safety regulatory requirements. The course will illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities. Product safety makes headlines every day - and the impact on a company's image, consumer confidence, and Wall Street's opinion is profound. Are you confident your current pharmacovigilance operations will meet the latest US, EU and UK expectations for compliance and keep your products on the market? Do you understand the processes needed to perform adequate risk assessment? Not knowing which systems and processes you must have in place for your own safety reporting could mean you miss an important issue with significant consequences for your product. You must be sure you have the understanding you need to avoid product recall, are able to work to international standards and have implemented regulatory requirements for signalling and risk management. What You'll Learn An understanding of regulatory requirements for drug safety Overview of US, EU and UK regulatory framework, including details of EU GVP modules and additional requirements for the UK Contents of the PV System Master File (PSMF) Requirements for quality oversight of drug safety Regulations for signal management EU and UK QPPV requirements and responsibilities An engaging and experienced instructor Multiple choice quizzes to test your understanding of the course Who Should Attend: Almost everyone involved in drug development and marketing needs to know the basics of worldwide regulations regarding drug who will benefit include: Drug safety and pharmacovigilance Regulatory affairs Clinical development Executives (including C-Level) with any legal responsibility for drug safety Key Topics Covered: Global Regulatory Requirements Legalities - US Legalities - EU Penalties for Non-Compliance Matrix of Safety Regulations FDA Regulations FDA Regulation for IND safety reporting IND Annual Report Literature Reporting International Conference on Harmonisation (ICH) ICH Topic Codes and Reports CIOMS Canadian Regulations Key EU Components EU Member States What is Europe? EU, EEA, EFTA EudraVigilance - Pre-Marketing Requirements EudraVigilance - Post-Marketing Requirements EUDRACT EU Clinical Trial Directive EU Clinical Trials Regulation CTIS Qualified Person for Pharmacovigilance (QPPV) requirements Development Safety Update Report European Signaling Regulations EU Pharmacovigilance Legislation Summary of Requirements Penalties and fees GVP modules Quality systems Audit and inspection PV System Master File (PSMF) ADR reporting EU and ex-EU Requirements Internet and Social Media Post-Authorisation Studies Biologics Periodic Safety Update Reports Periodic Benefit-Risk Evaluation Report PSUR Periodicity, ex-EU PSUR Periodicity, EU PSUR (PBRER) New Features PSUR Sections: Detailed Requirements Signal management MAH Responsibilities Signal Detection Signal Validation EudraVigilance Monitoring EudraVigilance Pilot Program UK Regulatory Requirements UK QPPV Quiz Questions Speakers: Steve Jolley DIA Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection. Steve has 37 years' experience in drug safety & pharmacovigilanceand has worked with 300 clients in North America, Europe, Japan, India, China, the Middle East, and Africa. He holds degrees in mathematics and computer science from Cambridge University, England. He is an Adjunct Professor at Rutgers University and developed part of their Master's degree in Drug Safety and Pharmacovigilance. Steve is a featured speaker with FDA, EMA and MHRA at conferences and webinars on auditing, signalling and data mining. He is a member of DIA's training faculty and is an instructor for DIA's Clinical Safety and Pharmacovigilance Certificate Program. In 2010 Steve was elected as chairman of the DIA's Clinical Safety and Pharmacovigilance steering committee for North America. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
03-06-2025
- Business
- Yahoo
Sixth Global Pharma Company Selects LifeSphere NavaX for GenAI-Driven Case Processing
Top 25 Global Life Science Organization Adopts NavaX, Demonstrating Industry Confidence in Scalable, GenAI-Enabled Technologies BOSTON, June 3, 2025 /PRNewswire/ -- ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, today announced that another Top 25 global pharmaceutical company has selected LifeSphere NavaX, the next-generation cognitive computing engine, to enhance case processing and pharmacovigilance operations. This milestone marks the sixth major pharmaceutical organization set to implement NavaX, underscoring industry-wide momentum toward intelligent automation and practical AI application across the R&D IT ecosystem. The company currently processes over 150,000 adverse event cases annually using the LifeSphere MultiVigilance platform. By leveraging NavaX, which includes dynamic data extraction and narrative generation capabilities, the organization will drive up to 65% efficiency gains across case processing while ensuring 90% data accuracy in intake. The NavaX implementation is set to go live in a few short months, in the fall of 2025. The decision to implement NavaX reflects a strategic commitment to deploying cutting-edge technologies to drive significant workflow efficiencies and cost savings, unlock insights across R&D teams, and enable optimal patient outcomes. Additional plans include expanding the use of NavaX to include signal detection, medical review augmentation, and global reporting. "This sixth global pharma adoption of NavaX is a clear signal that the future of pharmacovigilance is here," said Steve Nuckols, Chief Customer Officer at ArisGlobal. "We see a significant industry shift as leading organizations move from piloting AI to scaling it across global operations. NavaX empowers teams with the tools they need to work smarter, faster, and with greater confidence—and we're proud to be enabling that transformation." This announcement further cements LifeSphere NavaX as the innovation driver of choice for global pharma organizations seeking to accelerate, more intelligent workflows across the span of R&D IT spectrum. As more companies seek scalable, AI-augmented operations, ArisGlobal continues to lead the evolution of pharmacovigilance into the next era of automation and cognitive insights. About ArisGlobal ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, is transforming the way today's most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn. View original content to download multimedia: SOURCE ArisGlobal Sign in to access your portfolio
