Challenges in achieving excellence and ensuring compliance in the rapidly evolving global drug safety environment

Sciformix is a scientific knowledge-based global service provider for the Pharmaceutical, Biopharmaceutical, Medical Devices and Consumer Products industry. They partner with their clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Areas of specialization include Safety and Risk Management, Clinical Development, Biometrics, Scientific Writing, and …

Download: Presentation ‘CCDS, PSUR, RMP, DSUR, signal validation: Interrelations, modules and impact of the new GVP’

Véronique Basch, Executive Director, Global Pharmacovigilance, United BioSource Corporation, spoke at last year's World Drug Safety Congress Europe. I thought you might be interested in downloading her presentation on ‘‘CCDS, PSUR, RMP, DSUR, signal validation: Interrelations, modules and impact of the new GVP' for free. Download the presentation here. If you are interested in the topics discussed you might be …

Download: Whitepaper ‘Ensuring risk free pharmacovigilance’

Sciformix is a knowledge based global service provider for the Pharmaceutical and Biopharmaceutical industry. They partner with their clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Areas of specialization include Safety and Risk Management, Biometrics, Scientific Writing, and Regulatory Affairs. The increase in the …

Download: Whitepaper ‘Safety signal detection based on AERS data’

Sciformix is a knowledge based global service provider for the Pharmaceutical and Biopharmaceutical industry. They partner with their clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Areas of specialization include Safety and Risk Management, Biometrics, Scientific Writing, and Regulatory Affairs. Their signal detection and …

Top 3 scientific issues facing biosimilar development

Are you thinking about directing your R&D efforts in the direction of biosimilars?  Would knowing the scientific hurdles which are currently bottlenecking development aid in your decision making?  We posed this very question to over 200 individuals from a cross-section of the biosimilars industry and can provide you with an insight into this critical information. And the results are in: …

EMA opens nominations for CAT and PRAC committees

The EMA has made a new request for nomination for patients and healthcare-professionals to sit as representatives on the CAT (Committee for Advanced Therapies) and PRAC (Pharmacovigilance Risk Assessment) committees. It is important to have these key members represented in the committees to help review relevant information and provide a balanced perspective on the issues at hand. First attempts resulted …