pra, risk management, drug safety, world drug safety congress europe

Risk Management Planning and Mandated Post-Authorization Studies

Complex pharmacovigilance legislation in an evolving regulatory landscape has left drug makers searching for current, efficient and more meaningful solutions for their drug safety challenges, especially in the post-marketing arena. Companies are seeking expert advice and customized approaches to effectively collect, manage and analyze real-world evidence for a competitive advantage. Download whitepaper “Risk Management Planning and Mandated Post-Authorization Studies” from Agnes …

trilogy, drug safety, risk

Download whitepaper: Risk management plans – New challenges for a new era

  The risk management plan (RMP) is currently a hot topic and the focus of much discussion in industry due to the recent overhaul of the RMP guidance template. The complexity of the new RMP has introduced many challenges in preparing a high quality document compliant with all requirements, not least in the production of the newly legislated Part VI.2 …

Sciformix Whitepaper: Safety and Risk Management

  The area of safety signal detection has come into focus over the past few years and is growing in importance. It is well accepted that statistical methods of signal detection can flag certain drug-event combinations for in-depth analysis from a medical perspective, potentially leading to confirmation of evidence and identification of a signal. It is recognized that the quality of the data on which these methods are …

Download: Presentation ‘Assessing the effectiveness of Risk Management Plans’

Last night's Dispatches programme in the UK followed Deborah Cohen, Investigations Editor at the British Medical Journal, as she scrutinised diabetes medications, the benefits, the potential risks and the overall benefit risk balance of these medications. The risk benefit strategies for all drug is incredibly important and is a critical element used to reduce potential risks occurring and enlighten patients …

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 …

Post marketing safety: the industry’s key concern

I have been re-reviewing the drug safety survey results which have again proved interesting reading. Its a great way for us to keep up with what is happening in the industry as it allows safety colleagues to anonymously provide insight (and have a grumble) about the challenges of working in this sector. This survey shows clear patterns from the respondents …

Risk communication with Reinerio A. Deza #drugsafety

Reinerio A. Deza, MD, Head Global Pharmacovigilance, Cubist Pharmaceuticals spoke at the World Drug Safety Congress Americas last month on Risk Communication. He explained the purpose of risk communication as providing information regarding the positive and negative effects of a product to the intended user. He then went on to describes the process that takes place from identification through to …

Robin Geller, Baxter Healthcare Corporation, on the #Pharmacovigilance industry

Continuing with our series on the current pharmacovigilance industry we spoke with Robin Geller, Director of Risk Management and Safety Writing Global Pharmacovigilance, at Baxter Healthcare Corporation What is the biggest change that you are seeing in pharma's drug safety strategies at the moment? The continuing shift from submission of individual case reports to aggregate analysis, signal detection and risk …