Global Compliance:Regulatory bodies in countries such as Japan (PMDA) and Canada enforce comparable standards, highlighting the worldwide demand for high-quality pharmacovigilance translations. Challenges in Pharmacovigilance Translation Compliance Translating ICSRs presentsunique challenges, requiring a...
Paediatric cancer is the leading cause of death by disease in the US. The intent of the RACE for Children Act is to get more paediatric oncology drugs in the pipeline. Explore more updates on the RACE for Children Act The evolution of the Pharmacovigilance System Master File: Benefits, challe...
This includes the drug development process, pharmacovigilance, and manufacturing. Much of the day-to-day activities concerning the latter regulatory issues, however, are undertaken within the national regulatory bodies of the individual EU member states....
profile of a drug and to take appropriate corrective actions.Pharmacovigilance is not new to India, and has in fact been going onfrom 1998 when India Decided to join the Upsala centre for AdverseEvent Monitoring and already 16 years have passed. Something hasbeen achieved during this period, bu...
In order to enhance the supervision of drug safety in the period of clinical trial and gradually improve the life cycle management, the registration information in China Register would be incorporated into the pharmacovigilance system step by step as a whole for drug safety superv...
Healthcare: Pharmaceutical/Medical Products Regulatory 2024 | Band 5 | Morrison Foerster provides expert advice for a range of organizations in the life science and healthcare space. The team demonstrates its ability to handle a plethora of issues, including complex litigation, high-pr...
The MAH must “validate, monitor and document model performance and include AI/ML operations in the pharmacovigilance system, to mitigate risks related to all algorithms and models used.” The reflection paper highlights that a human-centric approach should guide all development and deployment of AI...
Artificial intelligence in personalized medicine application of AI algorithms in solving personalized medicine problems. Int J Comput Theory Eng. 2015;7(6):439. Article Google Scholar Murali K, Kaur S, Prakash A, Medhi B. Artificial intelligence in pharmacovigilance: practical utility. Mumbai: Med...
In August 2021, ProPharma Group acquired India-based iSafety Systems to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information. ...
European Medicines Agency. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).ENCePP website[online], (2010). European Medicines Agency. Press Release: EMEA-coordinated PROTECT project has been accepted for funding by the Innovative Medicines Initiative Joint Undertaking.EMA...