US FDA Commissioner Margaret Hamburg met with Indian health regulators and pharma execs, saying she wanted to see more collaboration between FDA and Indian officials. However, India’s top drug regulator, G.N. Singh, the Drug Controller General of India, feels a little reluctant about adhering to all of FDA’s standards and expectations. He says that he sees some areas where the …

pharmacovigilance, pharma, ipm safety services, ipm

Download whitepaper: Pharmacovigilance Outsourcing

  Over the past several years pharmaceutical companies have evaluated the cost of performing pharmacovigilance operations with a critical eye. Global regulatory requirements have continually increased with expanded focus on aggregated data assessments, and signal detection. These Global regulations require processes and systems to be in place for all aspects of Pharmacovigilance from receipt of individual case safety reports through …

Download: Drug Safety Outlook- Predictions and analysis of drug safety today and tomorrow

The drug safety sector is in a transition phase, progressing from a reactive to a more proactive mind-set. Change in the industry such as the new benefit risk standards, regulatory environment, safety informatic innovations and signal management processes, are all helping to help drive patient safety on the global scale. This is a critical change that will prioritise the patient, …

Guest Post: ‘EU pharmacovigilance changes have not addressed unsafe prescribing – experts’

This article was provided by APM Heatlh Europe from their coverage of the recent World Drug Safety Congress Europe 2013. LONDON, Sept 12 (APM) – Experts at a conference expressed support of last year’s shake-up of Europe’s pharmacovigilance rules but warned the changes had not done enough to address the issue of unsafe prescribing by medical professionals.In a panel discussion …

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: 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, …

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 ‘The benefit risk mindset & evolving management strategies’

Dr Robin Gellar, Director of Risk Management of Global Pharmacovigilance, Baxter International, spoke at this year's World Drug Safety Congress Americas. I thought you might be interested in downloading his presentation on ‘The benefit risk mindset & evolving management strategies' for free. Download the presentation here. Reasons to download: – A comprehensive review of the PSUR/PBRER in the EU– Learn …

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

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, …