Changing face of benefit risk management

At the World Drug Safety Congress Europe 2014 event, Lesly Wise, Takeda development Centre Europe, gave the presentation “Changing faceof Benefit Risk Management.” Download and learn: A brief History of Risk Management The impact of the 2012 legislation on risk management What do we need from a BR process Download Presentation Found this interesting? You might also be interested in …

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 …

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 …

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, …

Criteria for risk benefit balance

Roche's Michael Forstner spoke at the World Drug Safety Congress Europe and Americas in 2011. Following up to his interview in the blog last week I wanted to focus a bit of what he covered in his previous conference involvement. He brought his in-depth knowledge of pharmacovigilance and risk management to the meetings and has some interesting perspectives. He spoke …