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 …

Re-Imagining Drug Safety Powered by Genomics, Information Integration and Emerging Technologies

The global healthcare environment is undergoing transformation across the care delivery eco-system to provide more affordable and quality healthcare to all. The paper focusses on the next-generation drug safety models, and outlines the direction for realizing the emerging vision. Scientific advancements, emerging technologies and availability of large amount of information from different sources are offering newer opportunities for modernizing drug …

Benefit Risk Management

Be Prepared. Benefit risk management is mandated by current regulations. As existing regulations are updated and new regulations emerge in all regions, especially in the European Union and United States, the requirements placed on drug development and Marketing Authorization Holders for safety and benefit-risk assessment are steadily increasing. This has led to a significant increase in suitable resource needs. In …

tcs, drug safety, genomics, technology, world drug safety congress europe

Re-imagining Drug Safety

Re-imaginging Drug Safety: Powered by Genomics, Information Integration & Emerging Technologies by Debashis Ghosh, President – Life Science, Manufacturing and Energy, Tata Consultancy Services The video covers: Changing context Genomics and drug safety Information and insights integration Next generation drug safety architecture using emerging technologies Regulatory direction Putting it all together For more information on Drug Safety, join us at the …

Download: Audits and inspections since the new PV legislation – a personal reflection

Sue Rees, EU QPPV, Executive Director, Global Safety, Amgen gave a presentation at last year’s World Drug Safety Congress Europe entitled “Audits and inspections since the new PV legislation – a personal reflection”. Download the presentation to learn What has not changed? What has changed? How can you prepare for an inspection QPPV oversight Take home messages Download presentation For …

Download: Proactive Pharmacovigilance – A New Model for the 21st Century

Whitepaper courtesy of Sciformix 21st century technologies will create significant opportunities and challenges for all health care stakeholders. Pharmacovigilance too is in transition, with new sources of medical information and methods for its analysis that will transform today’s largely reactive system into proactive benefit-risk management for all medication users. Download the Proactive Pharmacovigilance – A New Model for the 21st …

video, patient, strategy, safety, patient safety, drug safety

Big opportunities for improving patient safety

What is Pharma’s biggest opportunity for improving patient safety over the next 5-10 years?  This question was posed to several attendees at last year’s World Drug Safety Congress Europe event.  Watch the video for their answers. Hear from: Christina Stoem Moeller, Astra Zeneca Logesvaran Yogendran, Janssen Pharmaceuticals Logesvaran Yogendran, Janssen Pharmaceuticals Marqus Hamwright, UCB Pharma Dr Simon Ingate, Pope Woodhead …

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 …

drug safety, insight, essentials, pharmacovigilance

Download: Essential Insights into Drug Safety

  Drug safety strategies are facing ongoing changes and developments as the pharma industry search for new and better ways of working and ensuring patient safety. The current transition from a reactive to a more proactive mind-set is being influenced by many things such as regulatory changes, patient awareness, new benefit risk standards, innovations in safety informatics and signal management …

QSI celebrates 10th anniversary

Press Release: Quantum Solutions India October 2014 marks our 10th anniversary. In this short space of time QSI has become the largest exclusive provider of Drug Safety services in the world. It is without question that our attention to quality, timeliness and cost effective Drug Safety service has captured the industry’s admiration. Currently serving clients in Europe and the USA, …