Guest Post: ‘Safety signal action still down to human judgement, conference hears’

This article was provided by APM Heatlh Europe from their coverage of the recent World Drug Safety Congress Europe 2013. LONDON, Sept 12 (APM) – Major drug companies make decisions on whether to act on safety signals using human judgement, despite the vast amount of pharmacovigilance data and statistical tools now available, a conference heard. Unlike clinical trials, where statistical …

Debashis Ghosh, TCS, gives his views on challenges and way forward in the drug safety sector

The responses below have kindly been provided by our World Drug Safety Congress Key Note Speaker – Mr Debashis Ghosh, Global Head – Life Sciences, Manufacturing and Energy, Tata Consultancy Services. Mr Ghosh will discuss ‘Reimagining Drug Safety powered by Genomics, Information Integration and Emerging Technologies' on the morning of day one. 1. What do you see as the biggest …

Download: TCS Viewpoint Paper – ‘Strategic Partnerships in Drug Development and Drug Safety’

The need for faster drug launches and increasing post-marketing compliance requirements are the main challenges that pharmaceutical companies confront today. They also grapple with rising R&D costs and the pressure of regulatory compliance while confronting the need to launch their products in established and emerging markets and look for new opportunities to grow. Therefore, their drug development and safety cycles …

Download: eBook ‘Top tips from World Drug Safety US 2013 – Part II’

The recent World Drug Safety Congress Americas was a great success with lots of learning, networking, discussion and debate taking place over the 2 days. There were some fantastic presentations which included some invaluable lessons, new approaches and novel strategies for drug safety in light of today's industry challenges. We have collated a few slides with fantastic take away points, …

TCS Named as a Leader in Life Science Drug Safety Services by Leading Industry Research Firm

Tata Consultancy Services, a leading IT services, consulting and business solutions organization recently announced that it has been designated as a Leader in Life Science Drug Safety Services (DSS) by the prominent global market intelligence firm IDC. The report cites TCS' significant industry expertise and wide range of capabilities as key leadership characteristics. "TCS' large life science customer base, broad …

Download: eBook ‘Successful strategic pharmacovigilance partnerships’

Partnerships play an integral part right across the pharma industry. Now more than ever before developing long term strategic partnerships in PV is proving to be vital. Several high-profile safety issues, regulatory warnings and negative media coverage have forever changed pharmacovigilance as we know it today. The best relationships between sponsors and contractors are those that are well defined from …

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 …

GLP-1 diabetes drugs and pancreatic damage – has it been underplayed? BMJ, Channel 4 investigate

The timing could have almost been scripted. No sooner had an FDA panel downplayed historic safety fears over GSK's Avandia than a new diabetes drug safety scare has reared its head. A paper, published this morning in the British Medical Journal, details the results of a joint investigation between the BMJ and Channel 4 Dispatches into the potential proliferative or …

Download: eBook ‘Key stakeholders insights into benefit risk communication’

We recently spoke to some of key stakeholders in drug safety to gain their insights into benefit risk communication. We've put their answers into an eBook for you to download. Download a copy here. The eBook contains answers to the following questions: What do you think are the weaknesses and strengths in current benefit/risk communication approaches? What do you see …